Drugs / CHS-1701
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | — | 2018-05-03 | “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,...” coherus.com ↗ “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 ↗ |
| Rejected (CRL) | US (FDA) | — | — | 2017-06-12 | “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...” coherus.com ↗ |
| Filed | EU (EMA) | — | — | 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) | — | — | 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 ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT02418104 | May → Dec 2015 | — | Coherus Oncology, Inc. | Completed | Met primary |
| Phase 1 | NCT02385851 | Feb → Jul 2015 | — | Coherus Oncology, Inc. | Completed | Met primary |
News releases announcing trial results or a regulatory action · 13
| Date | Issuer | Release |
|---|---|---|
| 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. |
| 2018-09-25 | 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. |
| 2018-07-27 | 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. |
| 2018-05-14 | 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. |
| 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. |
| 2016-02-01 | 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. |
| 2015-10-01 | Coherus Oncology, Inc. | Results Coherus Announces Topline Results of CHS-1701 Pharmacokinetic and Pharmacodynamic Biosimilarity Study coherus.com ↗
This study met its primary PD endpoints of absolute neutrophil count (ANC). |
All press releases naming this drug 16 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | CHS-1701 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02418104 ↗ |
| Known as | Coherus Pegfilgrastim | “Comparison of the Pharmacokinetic and Pharmacodynamic Biosimilarity of CHS-1701 (Coherus Pegfilgrastim) With Neulasta® (Pegfilgrastim)” NCT02385851 ↗1“Assessing the Immunogenicity of 2 Subcutaneous Doses of CHS-1701 (Coherus Pegfilgrastim) With 2 Subcutaneous Doses Neulasta®” NCT02418104 ↗ |
| Route | Subcutaneous | “single 6 mg subcutaneous (SC) injection of CHS-1701” NCT02385851 ↗ |