FDA: Amgen’s Biosimilar “Highly Similar” to Abbvie’s Humira

Goodwin
Contact

A preliminary review by FDA staff found that Amgen Inc.’s biosimilar of AbbVie Inc.’s Humira® showed potency and safety similar to the original product. Humira® (adalimumab) is the top-selling drug in the world and is used to treat autoimmune conditions including rheumatoid arthritis, Crohn’s disease, and ulcerative colitis. A panel will meet on Tuesday, July 12, 2016 to determine whether to recommend approval of Amgen’s biosimilar product, ABP 501.

Written by:

Goodwin
Contact
more
less

Goodwin on:

Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Custom Email Digest
- hide
- hide