Drugs / GP2013
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed follicular lymphoma, susceptibility to 1 milestone | |||||
| Filed | EU (EMA) | — | follicular lymphoma, susceptibility to | 2016-05-24 | “the European Medicines Agency has accepted their Marketing Authorization Application for a biosimilar to Roche's EU-licensed MabThera® (rituximab)” novartis.com ↗ |
| Filed Indication not stated 2 milestones | |||||
| Rejected (CRL) | US (FDA) | — | — | 2018-05-02 | “Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the Biologics Licensing Application (BLA) for its proposed biosimilar rituximab.” novartis.com ↗ |
| Filed | US (FDA) | — | — | 2017-09-12 | “accepted its Biologics License Application (BLA) under the 351 (k) pathway for a proposed biosimilar to the reference medicine, Rituxan ® ** (rituximab).” novartis.com ↗ |
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT01933516 | May 2013 → Aug 2014 | indolent B-cell non-Hodgkin lymphoma | Sandoz | Completed | No outcome recorded |
| Phase 1/21 trial · 1 met primary | ||||||
| Phase 1/2 | NCT01274182 | Jan 2011 → Jan 2016 | rheumatoid arthritis | Sandoz | Completed | Met primary |
| Phase 32 trials · 1 met primary | ||||||
| Phase 3 | NCT02514772 | Jul 2015 → Jul 2016 | rheumatoid arthritis | Sandoz | Completed | No outcome recorded |
| Phase 3 | NCT01419665 | Dec 2011 → Jul 2015 | follicular lymphoma | Sandoz | Completed | Met primary |
News releases announcing trial results or a regulatory action · 11
| Date | Issuer | Release |
|---|---|---|
| 2022-07-21 | Novartis Pharmaceuticals | Regulatory Sandoz Supplemental Biologics License Application accepted by US FDA for biosimilar Hyrimoz® (adalimumab-adaz) high concentration formulation (HCF) novartis.com ↗
Sandoz, a global leader in generic and biosimilar medicines, today announced that the US Food and Drug Administration (FDA) has accepted for review its Supplemental Biologics License Application (sBLA) for a high concentration formulation of 100 mg/mL (HCF) of its biosimilar Hyrimoz ® (adalimumab-adaz). |
| 2022-06-17 | Sandoz | Regulatory Sandoz Application for proposed biosimilar adalimumab’s high concentration formulation accepted by EMA sandoz.com ↗
Sandoz, a global leader in generic and biosimilar medicines, today announced that the European Medicines Agency (EMA) has accepted the application for high concentration formulation 100 mg/mL (HCF) of its biosimilar Hyrimoz® (adalimumab) for regulatory review. |
| 2022-06-17 | Novartis Pharmaceuticals | Regulatory Sandoz Application for proposed biosimilar adalimumab’s high concentration formulation accepted by EMA novartis.com ↗
Sandoz, a global leader in generic and biosimilar medicines, today announced that the European Medicines Agency (EMA) has accepted the application for high concentration formulation 100 mg/mL (HCF) of its biosimilar Hyrimoz ® (adalimumab) for regulatory review. |
| 2018-05-02 | Novartis Pharmaceuticals | Regulatory Sandoz receives complete response letter from the US FDA for proposed biosimilar rituximab novartis.com ↗
Sandoz, a Novartis division, announced today that the US Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the Biologics Licensing Application (BLA) for its proposed biosimilar rituximab. |
| 2017-11-14 | Novartis Pharmaceuticals | Results New data reinforces clinical basis for switching to Sandoz biosimilar medicines novartis.com ↗
Sandoz, a Novartis division and the global leader in biosimilars, today announces data from four clinical studies comparing its proposed biosimilar adalimumab and biosimilar rituximab with their reference medicines, Humira ® * and MabThera ® /Rituxan ® ** respectively[1]-[4]. |
| 2017-09-12 | Novartis Pharmaceuticals | Regulatory Sandoz proposed biosimilar rituximab accepted for review by the FDA novartis.com ↗ |
| 2017-06-19 | Novartis Pharmaceuticals | Regulatory Sandoz receives approval in Europe for Rixathon® (biosimilar rituximab) to treat blood cancers and immunological diseases novartis.com ↗
European Commission approves Sandoz Rixathon ® to treat blood cancers and immunological diseases. |
| 2017-04-21 | Novartis Pharmaceuticals | Regulatory Sandoz proposed biosimilars rituximab and etanercept recommended for approval in Europe* novartis.com ↗
Sandoz, a Novartis division, and the pioneer and global leader in biosimilars, announced today that the Committee for Medicinal Products for Human Use (CHMP) has adopted positive opinions, separately recommending the approval of both Sandoz' biosimilar rituximab and biosimilar etanercept in Europe, to treat the same indications as their respective reference medicines. |
| 2016-12-05 | Novartis Pharmaceuticals | Results New interim data demonstrate Sandoz proposed biosimilar rituximab has equivalent efficacy to reference product novartis.com ↗
The confirmatory safety and efficacy study shows GP2013 met its primary endpoint of overall response rate (ORR), demonstrating equivalence with the reference product, MabThera ®* , in 629 patients. |
| 2016-06-09 | Novartis Pharmaceuticals | Results New data demonstrates Sandoz' etanercept and rituximab biosimilar candidates bioequivalent to originator products novartis.com ↗
Sandoz' biosimilar rituximab candidate shows PK bioequivalence and similar pharmacodynamics (PD), safety, efficacy and immunogenicity. |
| 2016-05-24 | Novartis Pharmaceuticals | Regulatory Sandoz' biosimilar rituximab regulatory submission accepted by European Medicines Agency novartis.com ↗
Sandoz, a Novartis division and the global leader in biosimilars, announced today that the European Medicines Agency has accepted their Marketing Authorization Application for a biosimilar to Roche's EU-licensed MabThera® (rituximab). |
All press releases naming this drug 12 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | GP2013 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01274182 ↗ |
| Known as | rituximab | “GP2013 - A Proposed biosimilar rituximab” NCT02514772 ↗ |
| Route | Intravenous | “For i.v. administration, two 500 mg vials (1000 mg of active molecule) of concentrate are diluted in 0.9% NaCl solution and infused i.v.” NCT02514772 ↗ |