Drugs / Pegfilgrastim
Pegfilgrastim
also known as
Neulasta · pegylated G-CSF · B12019 · KRN125 · Neulastim · QL0605 · TPI-120 · biosimilar pegfilgrastim · +11 more
Regulatory milestones approvals, filings & regulatory actions · 16 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed cancer 2 milestones | |||||
| Filed | EU (EMA) | — | cancer | 2016-02-11 | “announced today that the European Medicines Agency (EMA) has accepted their Marketing Authorization Application (MAA) for its biosimilar to Amgen's EU-licensed Neulasta ®*...” novartis.com ↗ “Pfizer has also filed its pegfilgrastim biosimilar candidate for regulatory approval with the European Medicines Agency (EMA) and the application is currently under review.” pfizer.com ↗ “The EMA accepted Sandoz's regulatory submission for biosimilar Neulasta ® (pegfilgrastim), marking the division's fifth of 10 planned biosimilar filings through 2017.” novartis.com ↗ “L'Agence européenne des médicaments (EMA) a accepté la demande d'homologation réglementaire déposée par Sandoz pour son biosimilaire Neulasta® (pegfilgrastim)” novartis.com ↗ “Die Europäische Arzneimittelagentur (EMA) nahm den Zulassungsantrag von Sandoz für das Biosimilar Neulasta® (Pegfilgrastim) an.” novartis.com ↗ |
| Filed | US (FDA) | — | cancer | 2015-11-18 | “Der Zulassungsantrag von Sandoz für das Biosimilar Neulasta® (Pegfilgrastim), einen rekombinanten, humanen Granulozyten-Kolonie-stimulierenden Faktor, wurde von der FDA angenommen.” novartis.com ↗ “La FDA a accepté la demande déposée par Sandoz pour le biosimilaire de Neulasta® (pegfilgrastim), un facteur recombinant humain de stimulation des colonies de granulocytes.” novartis.com ↗ “FDA has accepted its Biologics License Application (BLA) under the 351 (k) pathway for its proposed biosimilar to Amgen's US-licensed Neulasta ® (pegfilgrastim)*” novartis.com ↗ “The FDA accepted Sandoz's regulatory submission for biosimilar Neulasta® (pegfilgrastim), a recombinant human granulocyte colony-stimulating factor.” novartis.com ↗ |
| Filed neutropenia 4 milestones | |||||
| Filed | US (FDA) | — | neutropenia | 2019-04-03 | “today announced resubmission of its Biologics License Application (BLA) for a proposed biosimilar pegfilgrastim to the US Food and Drug Administration (FDA)” novartis.com ↗ “Le biosimilaire pegfilgrastim proposé par Sandoz (Neulasta® d'Amgen) a été soumis à nouveau en avril à la FDA” novartis.com ↗ “Sandoz proposed biosimilar pegfilgrastim (Amgen's Neulasta ® ) was resubmitted to FDA in April” novartis.com ↗ |
| Rejected (CRL) | US (FDA) | — | neutropenia | 2017-06-12 | “Sandoz proposed biosimilar pegfilgrastim (Amgen's Neulasta ® ) was resubmitted to FDA in April, following the complete response letter received in June 2016.” novartis.com ↗ “complete response letter (“CRL”) for its biologics license application (“BLA”) for CHS-1701, a pegfilgrastim” coherus.com ↗ |
| Filed | EU (EMA) | — | neutropenia | 2016-11-29 | “today announced acceptance of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for CHS-1701, a pegfilgrastim (Neulasta®) biosimilar candidate.” coherus.com ↗ |
| Filed | US (FDA) | — | neutropenia | 2016-08-09 | “today announced submission of the biologics license application (BLA) for CHS-1701, a pegfilgrastim (Neulasta®) biosimilar candidate, to U.S. FDA under the 351(k) pathway.” coherus.com ↗ “today announced that the U.S. FDA has accepted the filing of 351(k) Biologics License Application for CHS-1701, a pegfilgrastim (Neulasta®) biosimilar candidate.” coherus.com ↗ |
| Approved Indication not stated 9 milestones | |||||
| Filed | US (FDA) | — | — | 2025-05-15 | “The company has submitted three separate Biologics License Applications to the FDA for biosimilar versions of trastuzumab, pegfilgrastim and filgrastim.” intaspharma.com ↗ |
| Filed | US (FDA) | — | — | 2021-06-02 | “the U.S. FDA has accepted the Biologics License Application (BLA) for its proposed biosimilar to Neulasta® (pegfilgrastim)” lupin.com ↗ |
| Filed | US (FDA) | — | — | 2020-05-27 | “Fresenius Kabi announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the company`s Biologics License Application (BLA) for MSB11455, a...” fresenius.com ↗ |
| Filed | EU (EMA) | — | — | 2020-05-22 | “The European Medicines Agency (EMA) has accepted for review Fresenius Kabi`s Marketing Authorization Application (MAA) for MSB11455, a biosimilar candidate of Neulasta®...” fresenius.com ↗ |
| Filed | US (FDA) | — | — | 2018-05-03 | “today announced the re-submission of its biologics license application (BLA) for CHS-1701, a pegfilgrastim (Neulasta®) biosimilar candidate, to the U.S. FDA under the 351(k) pathway.” coherus.com ↗ “FDA has accepted and acknowledged for review the re-submission of the biologics license application (BLA) for CHS-1701, a pegfilgrastim (Neulasta®) biosimilar candidate.” coherus.com ↗ |
| Filed | EU (EMA) | — | — | 2017-10-27 | “its biosimilar to EU-authorized Neulasta ®* (pegfilgrastim) has been accepted by the European Medicines Agency (EMA) for regulatory review.” novartis.com ↗ |
| Label expansions (2) | US (FDA) | NEULASTA | — | 2005-09-15 – 2015-11-13 | fda.gov ↗ |
| Approved | EU (EMA) | Neulasta | — | 2002-08-22 | europa.eu ↗ |
| Approved | US (FDA) | NEULASTA | — | 2002-01-31 | fda.gov ↗ |
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT06168188 | Jul 2020 → Dec 2024 | optic nerve disorder | Buddhist Tzu Chi General Hospital | Unknown | No outcome recorded |
| Phase 119 trials · 3 met primary | ||||||
| Phase 1 | NCT07416955 | Apr → Oct 2025 | — | Kashiv BioSciences, LLC | Completed | No outcome recorded |
| Phase 1 | NCT04873765 | Mar → Aug 2022 | neutropenia | Megalabs | Completed | No outcome recorded |
| Phase 1 | NCT04651036 | Nov 2020 → Nov 2021 | — | Qilu Pharmaceutical Co., Ltd. | Unknown | No outcome recorded |
| Phase 1 | NCT04015232 | Feb → Jun 2018 | — | Intas Pharmaceuticals, Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT04014062 | Feb → May 2018 | — | Intas Pharmaceuticals, Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT03251248 | Aug 2017 → May 2018 | — | Fresenius Kabi SwissBioSim GmbH | Completed | Met primary |
| Phase 1 | NCT03146988 | Apr → Sep 2017 | — | Gedeon Richter Plc. | Completed | No outcome recorded |
| Phase 1 | NCT03202927 | Mar 2017 → Mar 2018 | — | Adello Biologics, LLC | Completed | No outcome recorded |
| Phase 1 | NCT02912377 | Sep 2016 → May 2017 | — | Cinfa Biotech | Completed | No outcome recorded |
| Phase 1 | NCT03376503 | May 2016 → Oct 2017 | breast cancer | Nanogen Pharmaceutical Biotechnology Joint Stock Company | Completed | No outcome recorded |
| Phase 1 | NCT02629562 | Nov 2015 → Jul 2016 | — | Cinfa Biotech | Completed | No outcome recorded |
| Phase 1 | NCT02589301 | Nov 2015 → Mar 2016 | neutropenia | Eurofarma Laboratorios S.A. | Completed | No outcome recorded |
| Phase 1 | NCT02629289 | Aug 2015 → Jun 2016 | neutropenia | Pfizer | Completed | Met primary |
| Phase 1 | NCT02385851 | Feb → Jul 2015 | — | Coherus Oncology, Inc. | Completed | Met primary |
| Phase 1 | NCT02205320 | Feb → Aug 2014 | — | Dr. Reddy's Laboratories Limited | Unknown | No outcome recorded |
| Phase 1 | NCT01637493 | Feb 2012 → Feb 2013 | neutropenia | Hangzhou Jiuyuan Gene Engineering Co. Ltd. | Unknown | No outcome recorded |
| Phase 1 | NCT01037543 | Nov 2009 → Feb 2011 | — | Hanmi Pharmaceutical Company Limited | Completed | No outcome recorded |
| Phase 1 | NCT00969826 | Sep 2008 → Jan 2009 | — | Seoul National University Hospital | Completed | No outcome recorded |
| Phase 1 | NCT00662519 | Apr 2008 → Mar 2014 | type 1 diabetes mellitus | University of Florida | Completed | No outcome recorded |
| Phase 1/22 trials · 1 met primary | ||||||
| Phase 1/2 | NCT01106157 | Apr 2010 → Jan 2015 | type 1 diabetes mellitus | University of Florida | Completed | Met primary |
| Phase 1/2 | NCT01527422 | Jan 2006 → Nov 2010 | non-Hodgkin lymphoma | Fernando Cabanillas | Completed | No outcome recorded |
| Phase 241 trials · 2 met primary · 1 missed | ||||||
| Phase 2 | NCT07188090 | Oct 2025 → Dec 2027 expected | Hodgkins lymphoma, non-Hodgkin lymphoma, plasma cell myeloma | Thomas Jefferson University | Recruiting | No outcome recorded |
| Phase 2 | NCT06616987 | Jul 2025 → Jun 2027 expected | breast carcinoma | Yeon Hee Park | Recruiting | No outcome recorded |
| Phase 2 | NCT03993639 | May 2019 → Jul 2020 | disease related to hematopoietic stem cell transplant | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT03571633 | Aug 2018 → Jan 2027 expected | HER2 positive breast carcinoma | Centre Leon Berard | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04227990 | Nov 2017 → Oct 2018 | neutropenia | BeyondSpring Pharmaceuticals Inc. | Completed | No outcome recorded |
| Phase 2 | NCT02776059 | Jan 2017 → Mar 2020 | alcoholic hepatitis | Timothy Morgan, MD | Completed | Missed primary |
| Phase 2 | NCT03575520 | Jun 2016 → Feb 2017 | breast cancer | Yonsei University | Completed | No outcome recorded |
| Phase 2 | NCT01918241 | Jul 2013 → Jan 2016 | neutropenia | Hangzhou Jiuyuan Gene Engineering Co. Ltd. | Unknown | No outcome recorded |
| Phase 2 | NCT01724866 | Mar 2013 → Aug 2014 | neutropenia | Spectrum Pharmaceuticals, Inc | Completed | Met primary |
| Phase 2 | NCT01624805 | Jun 2012 → Jun 2029 expected | aplastic anemia, myelodysplastic syndrome | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT00856492 | Apr 2010 → Oct 2015 | breast cancer | SWOG Cancer Research Network | Completed | No outcome recorded |
| Phase 2 | NCT00794261 | Sep 2008 → Jan 2010 | plasma cell myeloma | Centre Leon Berard | Completed | No outcome recorded |
| Phase 2 | NCT00554463 | Jan 2008 → Aug 2011 | lung cancer | Radiation Therapy Oncology Group | Completed | No outcome recorded |
| Phase 2 | NCT01682044 | Apr 2007 → Nov 2013 | MALT lymphoma, chronic lymphocytic leukemia/small lymphocytic lymphoma, nodal marginal zone B-cell lymphoma, splenic marginal zone lymphoma | Roswell Park Cancer Institute | Completed | No outcome recorded |
| Phase 2 | NCT00478361 | Apr 2007 → Jun 2015 | bladder transitional cell carcinoma, renal pelvis/ureter urothelial carcinoma, urethra cancer | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT00470366 | Mar 2007 → Jun 2016 | central nervous system neoplasm, extragonadal germ cell tumor, ovarian cancer, teratoma +1 | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT00410696 | Sep 2006 → Nov 2008 | hematopoietic and lymphoid cell neoplasm | Armando Santoro, MD | Completed | Met primary |
| Phase 2 | NCT00364468 | Mar 2006 → Mar 2008 | neutropenia | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00526734 | Feb 2006 → ? | plasma cell myeloma | Erasme University Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT00695370 | Jan 2006 → Dec 2007 | cancer | University Hospital, Clermont-Ferrand | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT02469116 | Jan 2006 → Aug 2009 | ovarian carcinoma | Washington University School of Medicine | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT00306111 | Jan 2006 → Dec 2008 | non-Hodgkin lymphoma | University Hospital Tuebingen | Completed | No outcome recorded |
| Phase 2 | NCT00107510 | Aug 2005 → Sep 2007 | breast cancer | Alliance for Clinical Trials in Oncology | Completed | No outcome recorded |
| Phase 2 | NCT00031629 | Jan 2005 → Jul 2007 | leiomyosarcoma of the corpus uteri | Gynecologic Oncology Group | Completed | No outcome recorded |
| Phase 2 | NCT00453232 | Aug 2004 → Dec 2008 | extragonadal germ cell tumor, teratoma, testicular germ cell tumor | Cambridge University Hospitals NHS Foundation Trust | Completed | No outcome recorded |
| Phase 2 | NCT00169143 | May 2004 → Jan 2007 | diffuse large B-cell lymphoma | Lymphoma Study Association | Completed | No outcome recorded |
| Phase 2 | NCT00726700 | May 2004 → Feb 2012 | lymphoma | Saarland University | Completed | No outcome recorded |
| Phase 2 | NCT00067639 | Dec 2003 → Apr 2007 | plasma cell myeloma | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT00101127 | Dec 2003 → Jul 2006 | sarcoma | Gynecologic Oncology Group | Completed | No outcome recorded |
| Phase 2 | NCT00682383 | Sep 2003 → Jan 2010 | non-small cell lung carcinoma | Mt. Sinai Medical Center, Miami | Completed | No outcome recorded |
| Phase 2 | NCT00146562 | Jul 2003 → May 2007 | breast cancer | Harold J. Burstein, MD, PhD | Completed | No outcome recorded |
| Phase 2 | NCT00066092 | Apr 2003 → Mar 2004 | Hodgkins lymphoma, non-Hodgkin lymphoma | Amgen | Completed | No outcome recorded |
| Phase 2 | NCT00114764 | Mar 2003 → Apr 2004 | myeloid leukemia | Amgen | Completed | No outcome recorded |
| Phase 2 | NCT00117442 | Aug 2002 → Aug 2004 | breast cancer, lung cancer, ovarian cancer | Amgen | Completed | No outcome recorded |
| Phase 2 | NCT00117897 | Jul 2002 → Feb 2004 | non-Hodgkin lymphoma | Amgen | Completed | No outcome recorded |
| Phase 2 | NCT00004192 | May 2000 → Feb 2001 | lymphoma, neutropenia | University of Nebraska | Completed | No outcome recorded |
| Phase 2 | NCT00035620 | Apr 2000 → Jan 2007 | neutropenia, sarcoma | Amgen | Completed | No outcome recorded |
| Phase 2 | NCT00124111 | — | breast cancer | Amgen | Completed | No outcome recorded |
| Phase 2 | NCT00115414 | — | female breast carcinoma, neutropenia | Amgen | Completed | No outcome recorded |
| Phase 2 | NCT00117455 | — | non-Hodgkin lymphoma | Amgen | Completed | No outcome recorded |
| Phase 2 | NCT00751894 | — | cancer | University Hospital, Clermont-Ferrand | Unknown | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT01328938 | Oct 2010 → Nov 2012 | neutropenia | Green Cross Corporation | Completed | No outcome recorded |
| Phase 314 trials · 2 met primary | ||||||
| Phase 3 | NCT06520176 | Aug 2024 → Dec 2026 expected | hemopoietic proliferation, plasma cell myeloma | The Affiliated People's Hospital of Ningbo University | Recruiting | No outcome recorded |
| Phase 3 | NCT06116734 | Nov 2023 → Nov 2024 | neutropenia, plasma cell myeloma | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's | Unknown | No outcome recorded |
| Phase 3 | NCT02768714 | Jan 2018 → Oct 2019 | breast cancer | Eurofarma Laboratorios S.A. | Withdrawn | No outcome recorded Stop: Business |
| Phase 3 | NCT05283616 | May 2017 → Oct 2019 | neutropenia | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Completed | No outcome recorded |
| Phase 3 | NCT02953340 | May 2017 → Jun 2018 | breast cancer, neutropenia | Spectrum Pharmaceuticals, Inc | Completed | No outcome recorded |
| Phase 3 | NCT02643420 | Jan 2016 → Jan 2018 | breast cancer, neutropenia | Spectrum Pharmaceuticals, Inc | Completed | Met primary |
| Phase 3 | NCT03404752 | Aug 2015 → Jun 2018 | breast cancer | Gema Biotech S.A. | Unknown | No outcome recorded |
| Phase 3 | NCT02238873 | Oct 2014 → Jan 2018 | lymphoma, neutropenia | Rabin Medical Center | Unknown | No outcome recorded |
| Phase 3 | NCT00536081 | Jan 2008 → Dec 2009 | breast cancer | Maastricht University Medical Center | Completed | No outcome recorded |
| Phase 3 | NCT00516425 | Jan 2007 → ? | female breast carcinoma | Charing Cross Hospital | Unknown | No outcome recorded |
| Phase 3 | NCT00301925 | Dec 2005 → Sep 2024 | breast cancer | Institute of Cancer Research, United Kingdom | Unknown | Mixed |
| Phase 3 | NCT00433420 | Apr 2003 → May 2006 overdue | breast cancer | IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy | Active not recruiting | Mixed |
| Phase 3 | NCT00117910 | Oct 2002 → May 2004 | breast cancer | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT00035594 | Feb 2002 → Feb 2004 | neutropenia | Amgen | Completed | Met primary |
| Phase 46 trials · 2 met primary | ||||||
| Phase 4 | NCT06616571 | Sep 2024 → Dec 2025 overdue | chemotherapy-induced toxicity | Qilu Pharmaceutical Co., Ltd. | Recruiting | No outcome recorded |
| Phase 4 | NCT03511378 | Mar 2018 → Jan 2019 | breast cancer | Lupin Ltd. | Completed | Met primary |
| Phase 4 | NCT02782845 | Jun 2006 → Oct 2007 | non-Hodgkin lymphoma | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 4 | NCT00115206 | Jul 2002 → Jul 2004 | non-small cell lung carcinoma | Amgen | Completed | No outcome recorded |
| Phase 4 | NCT00277160 | Jun 2002 → Nov 2004 | breast cancer, lung cancer, neutropenia, non-Hodgkin lymphoma +1 | Amgen | Completed | Met primary |
| Phase 4 | NCT00030758 | Oct 2001 → ? | breast cancer, neutropenia | Anglo Celtic Cooperative Oncology Group | Unknown | No outcome recorded |
| Phase not applicable6 trials | ||||||
| — | NCT07525869 | Oct 2025 → Oct 2026 expected | triple-negative breast carcinoma | Yonsei University | Recruiting | No outcome recorded |
| — | NCT05296317 | Sep 2022 → Sep 2025 | breast carcinoma | Centre Georges Francois Leclerc | Completed | No outcome recorded |
| — | NCT01541072 | Feb 2012 → Jun 2014 | B-cell non-Hodgkin lymphoma | Centre Leon Berard | Terminated | No outcome recorded Stop: Enrollment |
| — | NCT00886509 | Mar 2009 → Feb 2015 | coronary artery disorder | Insel Gruppe AG, University Hospital Bern | Completed | No outcome recorded |
| — | NCT00689884 | Jan 2007 → Jan 2009 | hematopoietic and lymphoid cell neoplasm | Dartmouth-Hitchcock Medical Center | Terminated | No outcome recorded Stop: Enrollment |
| — | NCT00283621 | Jun 2003 → Apr 2006 | sarcoma | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Comparator or background therapy234 trials | ||||||
| Phase 0 | NCT02392039 Background | Dec 2015 → Apr 2018 | lymphoma | M.D. Anderson Cancer Center | Terminated | No outcome recorded Stop: Enrollment |
| Phase 0 | NCT00515138 Background | May 2007 → Nov 2011 | B-cell non-Hodgkin lymphoma | University of California, San Francisco | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT07278856 Background | Dec 2025 → Mar 2027 expected | Nodal T-follicular helper cell lymphoma, follicular type, angioimmunoblastic T-cell lymphoma, peripheral T-cell lymphoma, not otherwise specified | City of Hope Medical Center | Recruiting | No outcome recorded |
| Phase 1 | NCT06698861 Comparator | Aug 2024 → Feb 2025 | — | PharmaEssentia | Completed | No outcome recorded |
| Phase 1 | NCT05211336 Background | Apr 2022 → Jun 2024 overdue | diffuse large B-cell lymphoma of the central nervous system | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Show all 234 trials opens the full record — a long page | ||||||
News releases announcing trial results or a regulatory action · 54
| Date | Issuer | Release |
|---|---|---|
| 2026-08-25 | Biocon Biologics UK Ltd | Regulatory Biocon Announces Pegfilgrastim Biosimilar Marketing Approval by Japan Ministry of Health, Labour and Welfare (MHLW) bioconbiologics.com ↗
Biocon Biologics Ltd., a wholly-owned subsidiary of Biocon Ltd. (BSE code: 532523, NSE: BIOCON), received marketing approval for its pegfilgrastim biosimilar (“Product”) from Japan’s Ministry of Health, Labour and Welfare (MHLW). |
| 2025-11-30 | Lupin Limited | Regulatory Lupin Receives Approval from U.S. FDA for Biosimilar Armlupeg™ (Pegfilgrastim-unne) lupin.com ↗
Mumbai, Naples, December 1, 2025:Global pharma major Lupin Limited (Lupin), today announced that the United States Food and Drug Administration (U.S. FDA) has approved Armlupeg™ (pegfilgrastim-unne) 6 mg/0.6 mL injection for subcutaneous use in a single-dose prefilled syringe, as biosimilar to Neulasta® (pegfilgrastim) 6 mg/0.6 mL injection. |
| 2024-08-23 | Lupin Limited | Regulatory Lupin Receives Health Canada Approval for Biosimilar Pegfilgrastim lupin.com ↗ |
| 2023-12-26 | Coherus Oncology, Inc. | Regulatory Coherus Announces FDA Approval of UDENYCA ONBODY™, a Novel and Proprietary State-of-the-Art Delivery System for pegfilgrastim-cbqv coherus.com ↗ |
| 2023-10-05 | Coherus Oncology, Inc. | Regulatory Coherus Announces Resubmission of Biologics License Application (BLA) Supplement for UDENYCA® ONBODY™ coherus.com ↗
Coherus BioSciences, Inc. (Coherus, NASDAQ: CHRS) today announced the Company has resubmitted the Biologics License Application (BLA) Supplement for UDENYCA® ONBODY™, the company's on-body injector presentation of UDENYCA® (pegfilgrastim-cbqv), to the U.S. Food and Drug Administration (FDA) for review. |
| 2023-09-25 | Coherus Oncology, Inc. | Regulatory FDA Issues Complete Response Letter (CRL) for UDENYCA® ONBODY™ Biologics License Application Solely Due to an Ongoing Review of Inspection Findings at a Third-Party Filler; Coherus Also Announces Completion of Toripalimab FDA Inspections coherus.com ↗
The CRL did not identify any issues with the UDENYCA® ONBODY™ clinical efficacy or safety, trial design, labeling, drug substance manufacturing, or device design or manufacturing, and no additional data or trials have been requested. |
| 2023-07-24 | Kyowa Kirin, Inc. | Regulatory Kyowa Kirin Announces Application for Partial Change of Approved Indication of G-Lasta® for the Mobilization of Hematopoietic Stem Cells into Peripheral Blood for Autologous Blood Stem Cell Transplantation in Japan kyowakirin.com ↗
Kyowa Kirin Co., Ltd. (Kyowa Kirin, TSE:4151, President and CEO: Masashi Miyamoto) announced that the company has filed an application for partial change of approved indication of the sustained duration form of G-CSF(Granulocyte-Colony Stimulating Factor)*1 product G-Lasta® [KRN125, generic name: pegfilgrastim (genetical recombination)] for the mobilization of hematopoietic stem cells into peripheral blood in autologous blood stem cell transplantation*2 (the "indication") in Japan today. |
| 2023-03-06 | Coherus Oncology, Inc. | Regulatory FDA Approves UDENYCA® Autoinjector coherus.com ↗ |
| 2023-02-07 | Humanetics Corporation | Results BIO 300 Demonstrates Protection Against Radiation-Induced Lung Injury humaneticscorp.com ↗
The researchers concluded that both BIO 300 formulations, as well as the combination of BIO 300 with PEGfilgrastim, demonstrated significant efficacy in preventing radiation-induced lung inflammation and fibrosis, whereas PEGfilgrastim administered alone had minimal impact on such delayed lung injuries. |
| 2022-09-06 | Fresenius Kabi | Regulatory Fresenius Kabi receives U.S. FDA approval for biosimilar Stimufend®* (pegfilgrastim) fresenius.com ↗
The U.S. Food and Drug Administration (FDA) has approved Fresenius Kabi’s pegfilgrastim biosimilar, Stimufend®, for use in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. |
| 2022-05-27 | Impax Laboratories, LLC | Regulatory Amneal Achieves Third U.S. Biosimilar Approval with FYLNETRA™ (pegfilgrastim-pbbk) amneal.com ↗
today announced that the U.S. Food and Drug Administration (“FDA”) has approved the Company’s Biologics License Application (“BLA”) for pegfilgrastim-pbbk, a biosimilar referencing Neulasta ® . |
| 2022-04-04 | Kyowa Kirin, Inc. | Results Safety Data from a Clinical Trial of Automated InjectionDevice of G-Lasta® was Reported kyowakirin.com ↗
The study enrolled 35 patients and no serious adverse events or febrile neutropenia occurred. |
| 2022-03-30 | Fresenius Kabi | Regulatory Fresenius Kabi receives European Commission approval for its pegfilgrastim biosimilar Stimufend® fresenius.com ↗
The European Commission (EC) has granted Fresenius Kabi the marketing authorization for Stimufend®, the company’s pegfilgrastim biosimilar, for all approved indications of the reference medicine. |
| 2021-10-05 | Coherus Oncology, Inc. | Results Coherus Announces Positive Results of UDENYCA® On-Body Injector Clinical Trial coherus.com ↗
The study met all PK bioequivalence primary endpoints as well as the key secondary pharmacodynamic endpoint of ANC (absolute neutrophil count). |
| 2021-06-02 | Lupin Limited | Regulatory Lupin announces U.S. FDA acceptance for Pegfilgrastim Biosimilar application lupin.com ↗ |
| 2021-03-12 | Kyowa Kirin, Inc. | Regulatory Kyowa Kirin Announces Application for Partial Change of Approved Indication of G-Lasta® for the Mobilization of Hematopoietic Stem Cells into Peripheral Blood for Allogeneic Blood Stem Cell Transplantation in Japan kyowakirin.com ↗ |
| 2020-09-18 | Eisai Inc. | Results EISAI PRESENTS LATEST DATA OF PHASE I CLINICAL TRIAL ON LIPOSOMAL FORMULATION OF ANTI-CANCER AGENT HALAVEN® (ERIBULIN) AT ESMO VIRTUAL CONGRESS 2020 eisai.com ↗
Additionally, preventive treatment with the G-CSF (granulocyte colony stimulating factor) pegfilgrastim demonstrated a decrease in the ratio of febrile neutropenia occurrence (with treatment: 10.0%, without treatment: 33.3%). |
| 2020-06-11 | Pfizer | Regulatory FDA Approves Pfizer’s Oncology Supportive Care Biosimilar, NYVEPRIA™ (pegfilgrastim-apgf) pfizer.com ↗
Pfizer Inc. (NYSE: PFE) today announced the United States (U.S.) Food and Drug Administration (FDA) has approved NYVEPRIA™ (pegfilgrastim-apgf), a biosimilar to Neulasta ® (pegfilgrastim). |
| 2020-05-27 | Fresenius Kabi | Regulatory Fresenius Kabi’s regulatory submission for pegfilgrastim biosimilar accepted for review by FDA fresenius.com ↗
Fresenius Kabi announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the company`s Biologics License Application (BLA) for MSB11455, a biosimilar candidate of Neulasta® (pegfilgrastim)*. |
| 2020-05-22 | Fresenius Kabi | Regulatory Fresenius Kabi’s regulatory submission for pegfilgrastim biosimilar accepted for review by EMA fresenius.com ↗
The European Medicines Agency (EMA) has accepted for review Fresenius Kabi`s Marketing Authorization Application (MAA) for MSB11455, a biosimilar candidate of Neulasta® (pegfilgrastim)*. |
| 2019-11-05 | Novartis Pharmaceuticals | Regulatory Sandoz receives US FDA approval for long-acting oncology supportive care biosimilar Ziextenzo™ (pegfilgrastim-bmez) novartis.com ↗
Sandoz, a Novartis division and a global leader in biosimilars, today announced that the US Food and Drug Administration (FDA) approved its biosimilar Ziextenzo TM (pegfilgrastim-bmez). |
| 2019-06-05 | Hanmi Pharmaceutical Company Limited | Results <보도자료> 한미약품 파트너사들, 항암신약 연구결과 잇따라 발표 hanmi.co.kr ↗
스펙트럼은 두 연구의 총 4회 치료 주기에서 Pegfilgrastim 대비 ‘호중구감소증 발현 기간 및 안전성’의 비열등성 및 우수한 상대적 위험 감소율 등을 확인하며 롤론티스와 Pegfilgrastim의 유사한 약효 및 안전성을 입증했다. |
| 2019-04-03 | Novartis Pharmaceuticals | Regulatory Sandoz resubmits biosimilar pegfilgrastim application to US FDA novartis.com ↗
Sandoz, a Novartis division and a global leader in biosimilars, today announced resubmission of its Biologics License Application (BLA) for a proposed biosimilar pegfilgrastim to the US Food and Drug Administration (FDA) to address an FDA complete response letter received in June 2016. |
| 2019-03-18 | Coherus Oncology, Inc. | Regulatory Coherus BioSciences Receives Transitional Pass-Through Status from CMS coherus.com ↗
Coherus BioSciences, Inc. (Nasdaq: CHRS), today announced that the Centers for Medicare and Medicaid Services (CMS) approved UDENYCA™ (pegfilgrastim-cbqv) biosimilar for transitional pass-through payment status in the hospital outpatient setting. |
| 2018-11-30 | Biocon Biologics UK Ltd | Regulatory Biosimilar Pegfilgrastim Co-Developed by Biocon Receives Approval in EU bioconbiologics.com ↗
Fulphila®, a biosimilar Pegfilgrastim jointly developed by Biocon and Mylan, has been approved in EU. |
| 2018-11-30 | Coherus Oncology, Inc. | Regulatory Coherus BioSciences Announces Apexus Contract Agreement for 340B Hospitals and Clinics, and Q-Code Issuance from CMS coherus.com ↗
In addition to entering into a UDENYCA™ contract agreement with Apexus, Coherus BioSciences has received Q-Code medical billing status for UDENYCA™ from the Centers for Medicare and Medicaid Services (CMS). |
| 2018-11-27 | Novartis Pharmaceuticals | Regulatory Sandoz receives eighth European Commission approval for a biosimilar with Ziextenzo® (pegfilgrastim) novartis.com ↗
Sandoz, a Novartis division and the pioneer and global leader in biosimilars, today announced that the European Commission (EC) granted marketing authorization for biosimilar Ziextenzo ® (pegfilgrastim). |
| 2018-11-02 | Coherus Oncology, Inc. | Regulatory U.S. FDA Approves UDENYCA™ (pegfilgrastim-cbqv) coherus.com ↗
Coherus BioSciences, Inc. (NASDAQ: CHRS), today announced that the U.S. Food and Drug Administration (FDA) has approved UDENYCA™ (pegfilgrastim-cbqv), the first pegfilgrastim biosimilar approved by both the FDA and the European Commission (EC) for patients with cancer receiving myelosuppressive chemotherapy. |
| 2018-10-09 | Fresenius Kabi | Results Fresenius Kabi biosimilar candidate meets primary endpoints in the two pivotal clinical studies fresenius.com ↗
MSB11455, a biosimilar candidate for Neulasta ® (pegfilgrastim), has met its primary endpoints in the two pivotal clinical studies. |
| 2018-09-25 | Coherus Oncology, Inc. | Regulatory Coherus BioSciences Receives European Commission Approval for UDENYCA™ (Pegfilgrastim Biosimilar) coherus.com ↗
Coherus BioSciences, Inc. (Nasdaq: CHRS), today announced the European Commission (EC) has granted marketing authorization to UDENYCA™ (formerly CHS-1701), a pegfilgrastim (Neulasta®) biosimilar. |
| 2018-09-21 | Novartis Pharmaceuticals | Regulatory Sandoz receives positive CHMP opinion for proposed biosimilar pegfilgrastim novartis.com ↗
Sandoz, a Novartis division and the pioneer and global leader in biosimilars, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for marketing authorization of its proposed biosimilar pegfilgrastim, ® *** a long-acting version of supportive oncology care medicine filgrastim. |
| 2018-07-27 | Coherus Oncology, Inc. | Regulatory Coherus BioSciences Receives Positive CHMP Opinion for UDENYCA™ (Pegfilgrastim Biosimilar Candidate) coherus.com ↗
today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the marketing authorization of UDENYCA™ (formerly CHS-1701), a pegfilgrastim (Neulasta®1) biosimilar candidate. |
| 2018-06-01 | Apotex Inc. | Regulatory Apotex Builds Momentum in Canada's Biosimilar Market After World's First Approval apotex.com ↗
The recent Health Canada approval is a noteworthy success for Apobiologix as this is the first-ever pegfilgrastim biosimilar approved in any highly regulated market worldwide. |
| 2018-05-14 | Coherus Oncology, Inc. | Regulatory U.S. Food and Drug Administration Accepts and Acknowledges Coherus BioSciences Biologics License Application of CHS-1701 (Pegfilgrastim Biosimilar Candidate) for Review coherus.com ↗
Coherus BioSciences, Inc. (NASDAQ:CHRS), today announced the U.S. Food and Drug Administration (FDA) has accepted and acknowledged for review the re-submission of the biologics license application (BLA) for CHS-1701, a pegfilgrastim (Neulasta®) biosimilar candidate. |
| 2018-05-03 | Coherus Oncology, Inc. | Regulatory Coherus BioSciences Re-Submits Biologics License Application for CHS-1701 (Pegfilgrastim Biosimilar Candidate) coherus.com ↗
REDWOOD CITY, Calif., May 03, 2018 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (NASDAQ:CHRS), today announced the re-submission of its biologics license application (BLA) for CHS-1701, a pegfilgrastim (Neulasta®) biosimilar candidate, to the U.S. FDA under the 351(k) pathway. |
| 2018-02-27 | Amgen | Regulatory Amgen Receives Positive CHMP Opinion For Delivery System Of Neulasta® (pegfilgrastim) amgen.com ↗
Amgen (NASDAQ:AMGN) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending a label variation for Neulasta ® (pegfilgrastim) to include the Neulasta ® Onpro ® Kit. |
| 2017-12-08 | Novartis Pharmaceuticals | Results Sandoz announces new Phase I data showing proposed biosimilar pegfilgrastim matches reference medicine novartis.com ↗
The Phase I study, conducted in healthy volunteers, confirmed that Sandoz biosimilar pegfilgrastim matches the reference biologic in terms of PK, PD, safety and immunogenicity profiles[1]. |
| 2017-10-27 | Novartis Pharmaceuticals | Regulatory Sandoz proposed biosimilar pegfilgrastim accepted by EMA for regulatory review novartis.com ↗
Sandoz, a Novartis Division, and the global leader in biosimilars, announced today that its biosimilar to EU-authorized Neulasta ®* (pegfilgrastim) has been accepted by the European Medicines Agency (EMA) for regulatory review. |
| 2017-06-12 | Coherus Oncology, Inc. | Regulatory Coherus BioSciences Receives Complete Response Letter from FDA for its Biologics License Application for CHS-1701 (Pegfilgrastim Biosimilar Candidate) coherus.com ↗
today announced that the U.S. Food and Drug Administration (“FDA”) has issued a complete response letter (“CRL”) for its biologics license application (“BLA”) for CHS-1701, a pegfilgrastim (Neulasta®) biosimilar candidate, under the 351(k) pathway. |
| 2016-11-29 | Coherus Oncology, Inc. | Regulatory Coherus’ Marketing Authorization Application to European Medicines Agency for CHS-1701 (Pegfilgrastim Biosimilar Candidate) Accepted coherus.com ↗
today announced acceptance of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for CHS-1701, a pegfilgrastim (Neulasta®) biosimilar candidate. |
| 2016-10-06 | Coherus Oncology, Inc. | Regulatory Coherus BioSciences Announces FDA Acceptance of 351(k) Biologics License Application to U.S. Food and Drug Administration for CHS-1701 (Pegfilgrastim Biosimilar Candidate) coherus.com ↗
today announced that the U.S. FDA has accepted the filing of 351(k) Biologics License Application for CHS-1701, a pegfilgrastim (Neulasta®) biosimilar candidate. |
| 2016-08-09 | Coherus Oncology, Inc. | Regulatory Coherus BioSciences Submits 351(k) Biologics License Application to U.S. Food and Drug Administration for CHS-1701 (Pegfilgrastim Biosimilar Candidate) coherus.com ↗
Coherus BioSciences, Inc. (NASDAQ:CHRS), today announced submission of the biologics license application (BLA) for CHS-1701, a pegfilgrastim (Neulasta®) biosimilar candidate, to U.S. FDA under the 351(k) pathway. |
| 2016-07-11 | Coherus Oncology, Inc. | Results Coherus Announces Positive Topline Results for CHS-1701 (Pegfilgrastim Biosimilar Candidate) Pharmacokinetic and Pharmacodynamic Biosimilarity Study coherus.com ↗
This study met all of its co-primary endpoints for PK, Cmax and Area Under the Curve (AUC), and PD, absolute neutrophil count, and ANC (ANCmax and ANC AUC). |
| 2016-02-29 | Coherus Oncology, Inc. | Results Coherus BioSciences Reports Fourth Quarter and Year End 2015 Financial and Operating Results coherus.com ↗
Met primary endpoints in an immunogenicity study in healthy volunteers initiated in 2015 and completed in February 2016. |
| 2016-02-11 | Novartis Pharmaceuticals | Regulatory Sandoz advances its biosimilars program with EMA acceptance of regulatory submission for biosimilar pegfilgrastim novartis.com ↗
Sandoz, a Novartis company and the global leader in biosimilars, announced today that the European Medicines Agency (EMA) has accepted their Marketing Authorization Application (MAA) for its biosimilar to Amgen's EU-licensed Neulasta ®* (pegfilgrastim) - a long-acting recombinant human granulocyte colony-stimulating factor (G-CSF). |
| 2016-02-01 | Coherus Oncology, Inc. | Results Coherus Announces CHS-1701 (Neulasta® Biosimilar) Met Both Primary Endpoints in Registration-Enabling Immunogenicity Study coherus.com ↗
This study successfully met both pre-specified immunogenicity endpoints. |
| 2015-12-07 | Novartis Pharmaceuticals | Results Phase III data shows Sandoz' proposed biosimilar pegfilgrastim has similar safety and efficacy as the reference product novartis.com ↗
Sandoz, a Novartis company and global leader in biosimilars, today announced results from the PROTECT 2 study which compared the safety and efficacy of proposed biosimilar pegfilgrastim with the reference product, Neulasta®*. |
| 2015-11-18 | Novartis Pharmaceuticals | Regulatory Regulatory submission for Sandoz' proposed biosimilar pegfilgrastim accepted by the FDA novartis.com ↗
The FDA's acceptance of our regulatory submission for biosimilar pegfilgrastim - our third biosimilar filed in the US - demonstrates our commitment to expanding patient access to biologics in the US |
| 2015-03-02 | Dong-A ST Co., Ltd. | Regulatory 동아ST, 호중구감소증치료제 ‘듀라스틴 주사액’ 건강보험 급여 개시 donga-st.com ↗
동아에스티(대표이사 사장 박찬일)는 호중구감소증치료제인 ‘듀라스틴 주사액(성분명: Tripegfilgrastim, 트리페그필그라스팀)’이 건강보험심사평가원으로부터 보험 약가를 취득해 3월 1일부터 건강보험 적용을 받는다고 밝혔다. |
| 2014-09-26 | Kyowa Kirin, Inc. | Regulatory Approval for Sustained-Duration G-CSF Product G-Lasta® in Japan kyowakirin.com ↗
Kyowa Hakko Kirin Co., Ltd. (Tokyo: 4151, President and CEO: Nobuo Hanai, "Kyowa Hakko Kirin") announced today that it has received approval for sustained-duration G-CSF product G-Lasta® subcutaneous injection 3.6mg (G-Lasta®) [generic name: pegfilgrastim (genetical recombination)] by the Ministry of Health, Labour and Welfare (MHLW). |
| 2013-06-27 | Kyowa Kirin, Inc. | Regulatory Kyowa Hakko Kirin Submits Application for Approval in Japan for Sustained-Duration G-CSF Product (KRN125) kyowakirin.com ↗
Kyowa Hakko Kirin Co., Ltd. (Tokyo: 4151, President and CEO: Nobuo Hanai, "Kyowa Hakko Kirin") announced today that it has filed an application for marketing approval to the Ministry of Health, Labour and Welfare (MHLW) for sustained-duration G-CSF product KRN125 (generic name: pegfilgrastim) which is currently undergoing development for the treatment of chemotherapy-induced febrile neutropenia. |
| 2013-01-25 | Kyowa Kirin, Inc. | Results Results of Phase 3 Clinical Trials of KRN125 in Patients with Malignant Lymphoma and Breast Cancer in Japan kyowakirin.com ↗
Each study meets the primary endpoints. |
| 2011-06-06 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva Announces Successful Results of Phase III Study of Its Long-Acting G-CSF Product (Lipegfilgrastim) in Breast Cancer Patients tevapharm.com ↗
We are pleased with the successful results of this Phase III study. |
| 2011-05-31 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva Announces Data on Granulocyte Colony Stimulating Factor Compounds for the Prevention of Chemotherapy-Induced Neutropenia in Breast Cancer Patients tevapharm.com ↗
A Phase II/III study of CG-10639, a long-acting recombinant human albumin-human G-CSF to prevent chemotherapy-induced neutropenia, demonstrated similar outcomes to pegfilgrastim (PEGF), for both efficacy and safety measures in breast cancer patients. |
All press releases naming this drug 70 releases
Evidence & citations 23 cited values
Every value below carries the sentence it was read from. 325 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | pegfilgrastim | “The study was an assessor-blind, balanced, randomized, two-treatment, two-period, single-dose, two-way crossover, comparative, pharmacokinetic (PK) and pharmacodynamic (PD)...” NCT04014062 ↗290“Pegfilgrastim will be administered at a dosage of 6 mg subcutaneously on Day 4 to help prevent neutropenia. Alternatively, participants received filgrastim 5 ug/kg/d starting...” NCT00211185 ↗ “Participants randomized to this arm will receive abiraterone acetate (1000 mg/day), prednisone (5 mg twice daily), leuprolide (22.5 mg every 3 months), and cabazitaxel (20...” NCT02543255 ↗ “Recommended rescue medications are pegfilgrastim or equivalent, histamine-1 (H1) receptor antagonist, histamine-2 (H2) receptor antagonist, acetaminophen or equivalent,...” NCT07419295 ↗ “Rescue medications include pegfilgrastim (or equivalent), H1 receptor antagonist, H2 receptor antagonist, acetaminophen (or equivalent), dexamethasone (or equivalent), steroid...” NCT07829783 ↗ “PEG-Filgrastim would be given in order to allow us to administer the chemotherapy courses every 2 weeks with the practical advantage of requiring only one dose of...” NCT01527422 ↗ “Pegylated GCSF (PEG-GCSF) (e.g. pegfilgrastim) on-body injector (OBI) or daily GCSF (e.g. filgrastim) will be given according to institutional policy after Day 5 of topotecan.” NCT02649673 ↗ “Two-weekly administrations of 600 mg/m2 cyclophosphamide and 60 mg/m2 doxorubicin PEG-filgrastim (Neulasta(r)) will be administered on the day following chemotherapy.” NCT01057069 ↗ “The aim of this trial was to determine the safety and efficacy of pegfilgrastim, a long-acting recombinant GCSF, in patients with AH in the United States.” PMID 36267499 ↗ Oct 2022 “All patients will receive G-CSF (peg-filgrastim or filgrastim) starting on day -4, prior to planned peripheral blood stem cell collection on day 0.” NCT07188090 ↗ “Pegfilgrastim (given at 6 mg subcutaneous for one dose approximately 24 hours after completion of the chemotherapy) may be substituted for G-CSF.” NCT00968253 ↗ |
| Known as | B12019 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02912377 ↗ |
| Known as | biosimilar pegfilgrastim | “biosimilar pegfilgrastim” NCT06116734 ↗ |
| Known as | KRN125 | “Dose Finding Study of KRN125 (Pegfilgrastim) for Treatment of Neutropenic Patients” NCT00364468 ↗1“after a single subcutaneous (SC) dose of KRN125(Pegfilgrastim)in healthy adults.” NCT03993639 ↗ |
| Known as | Lapelga | “Biosimilar pegfilgrastim or Lapelga™ (one dose)” NCT06116734 ↗ |
| Known as | Nanogen pegfilgrastim | “Pegcyte (Nanogen pegfilgrastim)” NCT03376503 ↗ |
| Known as | Neulasta | “Granulocyte colony stimulating factor (Neulasta 6 mg sc) with each cycle, starting with the first cycle, to minimize the risk of complications from neutropenia.” NCT01750866 ↗46“Pegfilgrastim (Neulasta) fixed dose of 6mg (0.6mL of a 10mg/mL solution) as a single subcutaneous injection on Day 2 of each study cycle.” NCT00291850 ↗ “compared with Neulasta® (pegfilgrastim) in women with breast cancer who are receiving myelotoxic chemotherapy.” NCT01648322 ↗ “Pegfilgrastim (Neulasta) fixed dose of 6 mg (0.6 mL of a 10 mg/mL solution) as a single subcutaneous injection” NCT00256360 ↗ “It is at the discretion of the treating physician to give Neulasta, 6 mg sq x 1 post treatment” NCT02578732 ↗ “Single subcutaneous administration of Pegfilgrastim (Neulasta® - Laboratory AMGEN) 6 mg at D5” NCT00794261 ↗ “ASCT,Rituxan, Ifex, Paraplatin®, etoposide, Vepesid®, Mesnex®, Neupogen, Neulasta” NCT00588094 ↗ “or receive equivalent single dose of Neulasta every 14 days while neutropenic” NCT03649438 ↗ “Mobilization: one sc injection of 300 µg/kg pegfilgrastim (Neulasta, Amgen)” NCT00695370 ↗ “Neulasta injection 6mg subcutaneous” NCT02592395 ↗ “Neulasta 6mg SQ will also be given” NCT01125787 ↗ |
| Known as | Neulasta(r) | “Two-weekly administrations of 600 mg/m2 cyclophosphamide and 60 mg/m2 doxorubicin PEG-filgrastim (Neulasta(r)) will be administered on the day following chemotherapy.” NCT01057069 ↗ |
| Known as | Neulastim | “An Expanded Access Program of Pegfilgrastim (Neulastim) in Participants With Non-Hodgkin's Lymphoma (NHL)” NCT02782845 ↗1“Neulastim (Roche pegfilgrastim)” NCT03376503 ↗ |
| Known as | Peg Filgrastim[Neulasta (G-CSF or GCSF)] | “Peg Filgrastim[Neulasta (G-CSF or GCSF)]” NCT01527422 ↗ |
| Known as | PEG-rhG-CSF | “QL0605(PEG-rhG-CSF)” NCT06616571 ↗ |
| Known as | Pegcyte | “Pegcyte (Nanogen pegfilgrastim)” NCT03376503 ↗ |
| Known as | Pegfilgastim Amgen | “Biological: Pegfilgastim Amgen” NCT04873765 ↗ |
| Known as | Pegfilgastrim Megalabs | “Biological: Pegfilgastrim Megalabs” NCT04873765 ↗ |
| Known as | Pegfilgrastim Amgen | “Administration of 6 mg of Pegfilgrastim Amgen subcutaneous single dose” NCT04873765 ↗ |
| Known as | Pegfilgrastim Megalabs | “Administration of 6 mg of Pegfilgrastim Megalabs subcutaneous single dose” NCT04873765 ↗ |
| Known as | pegylated G-CSF | “Myeloid growth factor (G-CSF or pegylated G-CSF)” NCT02390843 ↗ |
| Known as | QL0605 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06616571 ↗ |
| Known as | Roche pegfilgrastim | “Neulastim (Roche pegfilgrastim)” NCT03376503 ↗ |
| Known as | TPI-120 | “Pharmacokinetic, Immunogenicity, and Safety Evaluation of Pegfilgrastim TPI-120 in Healthy Adults” NCT07416955 ↗1“TPI-120 (PEGFILGRASTIM)” NCT03202927 ↗ |
| Action | Activate | “Colony-stimulating factor” NCT02834403 ↗ |
| Modality | Protein / enzyme biologic | “Growth factor (GCSF) administered to promote neutrophil development post-chemotherapy.” NCT00035594 ↗ |
| Route | Subcutaneous | “Alternatively, patients may receive pegfilgrastim SC beginning 24-36 hours after completion of each course of chemotherapy and continuing until blood counts recover.” NCT00003955 ↗ |