Catalyst
Slingshot members are tracking this event:
Amgen Announces FDA Advisory Committee Meeting To Review ABP 501, A Biosimilar Candidate To Adalimumab
Do you think this event is important to the companies below? How will it affect their stock price?
| Related Companies | Importance
|
Impact on Stocks
|
||||
|---|---|---|---|---|---|---|
| AMGN | Community voting in process | |||||
Additional Information
The Committee will review analytical, clinical and pharmacokinetic data from studies involving ABP 501, including results from two Phase 3 comparative efficacy and safety studies conducted in both moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis. The Phase 3 studies met their primary endpoints showing clinical equivalence to adalimumab. Safety and immunogenicity of ABP 501 were also comparable to adalimumab. Data to support the transition of adalimumab patients to ABP 501 are included in the submission.
Slingshot Insights Explained
Catalyst Date
Occurred on:
Sep 23, 2016
Occurred Source:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm522243.htm
Related Projects
-
Don’t see a project related to the catalyst you care about?
Related Keywords
Rheumatoid Arthritis, Adalimumab, Abp 501, Humira
