Drugs / ABP 215
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | EU (EMA) | — | — | 2016-12-02 | “today announced the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for ABP 215” amgen.com ↗ |
| Filed | US (FDA) | — | — | 2016-11-15 | “today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration ( FDA ) for ABP 215” amgen.com ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT04466917 | May 2021 → Nov 2022 | non-small cell lung carcinoma | Amgen | Withdrawn | No outcome recorded Stop: Business |
| Phase 3 | NCT01966003 | Nov 2013 → Jul 2015 | non-small cell lung carcinoma | Amgen | Completed | Met primary |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2017-11-10 | Amgen | Regulatory Amgen And Allergan Receive Positive CHMP Opinion For ABP 215 (Biosimilar Bevacizumab) For The Treatment Of Certain Types Of Cancer amgen.com ↗
Amgen (NASDAQ:AMGN) and Allergan plc . (NYSE:AGN) today announced that 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 ABP 215, a biosimilar to Avastin ® (bevacizumab). |
| 2017-06-07 | Amgen | Results Amgen And Allergan Announce FDA Advisory Committee Meeting To Review ABP 215, A Biosimilar Candidate To Bevacizumab amgen.com ↗
The Phase 3 study met its primary endpoint showing clinical equivalence to bevacizumab. |
| 2016-12-02 | Amgen | Regulatory Amgen And Allergan Submit Biosimilar Marketing Authorization Application To European Medicines Agency For ABP 215, A Biosimilar Candidate To Bevacizumab amgen.com ↗
Amgen (NASDAQ:AMGN) and Allergan plc . (NYSE:AGN) today announced the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for ABP 215, a biosimilar candidate to Avastin ® (bevacizumab). |
| 2016-11-15 | Amgen | Regulatory Amgen And Allergan Submit Biosimilar Biologics License Application For ABP 215 To U.S. Food And Drug Administration amgen.com ↗
Amgen (NASDAQ:AMGN) and Allergan plc . (NYSE:AGN) today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration ( FDA ) for ABP 215, a biosimilar candidate to Avastin ® (bevacizumab). |
| 2015-09-23 | Amgen | Results Amgen And Allergan Announce Positive Top-line Results From Phase 3 Study of Biosimilar Candidate ABP 215 amgen.com ↗
Amgen (NASDAQ:AMGN) and Allergan plc . (NYSE:AGN) today announced a Phase 3 study of biosimilar candidate ABP 215 met its primary and secondary endpoints. |
All press releases naming this drug 6 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ABP 215 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04466917 ↗ |
| Route | Intravenous | “by IV infusion” NCT01966003 ↗ |