Big Molecule Watch
July 25, 2019

FDA Approves Samsung Bioepis’s HADLIMA (adalimumab-bwwd)

Earlier this week, the U.S. FDA approved Samsung Bioepis’s  HADLIMA (adalimumab-bwwd), a biosimilar referencing HUMIRA, for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis, and plaque psoriasis. HADLIMA is the fourth adalimumab biosimilar to receive approval in the U.S.

According to a Samsung Bioepis press release, HADLIMA will be commercialized in the U.S. by Merck, and is expected to launch in the U.S. after June 30, 2023, in accordance with a licensing agreement signed with AbbVie Inc. (previously reported on here).

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