Slingshot members are tracking this event:

FDA Accepts Amgen's Biosimilar Biologics License Application For ABP 501, a Humira (adalimumab) biosimilar candidate; BsUFA target action date set for Sept. 25 2016, for ABP 501

Do you think this event is important to the companies below? How will it affect their stock price?

Related Companies
High Medium Low
Impact on Stocks
AMGN Community voting in process

Additional Information

Additional Relevant Details The BLA, submitted on Nov. 25, 2015, is based on analytical, clinical and pharmacokinetic data. Phase 3 comparative efficacy and safety studies were 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:
Jan 25, 2016
Related Projects Image
  • Don’t see a project related to the catalyst you care about?

Related Keywords Fda Acceptance, Bla, Biosimilar, Abp 501