FDA Okays Amgen’s First Biosimilar, Company Tells AbbVie It Will Provide Notice

September 23, 2016 at 7:12 PM
FDA approved Amgen’s first biosimilar product, a version of AbbVie’s Humira, Friday (Sept. 23), bringing the agency's total number of biosimilar approvals to four. The drug received support from the agency’s advisory committee, but is the subject of litigation like many of the other approved and pending biosimilar applications. The biosimilar, Amjevita, is approved to treat moderately to severely active rheumatoid arthritis; active psoriatic arthritis; active ankylosing spondylitis; moderately to severely active Crohn’s disease; moderately to severely active ulcerative colitis;...


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