FDA Accepts Sandoz aBLA for Adalimumab Biosimilar

Sandoz, a division of Novartis, announced on Tuesday that the FDA has accepted for review its BLA under the 351(k) pathway for a biosimilar candidate to AbbVie’s Humira (adalimumab). According to the press release, adalimumab “is indicated for the treatment of a number of inflammatory diseases including rheumatoid arthritis, plaque psoriasis, Crohn’s disease and ulcerative colitis.”

The FDA previously accepted for review two other aBLAs for adalimumab biosimilars: one for Amjevita, manufactured by Amgen, and the other for Cyltezo, manufactured by Boehringer Ingelheim. The FDA approved Amjevita for marketing in September of 2017 and Amgen reached a settlement agreement with AbbVie that would allow it to launch the product in the U.S. in 2023. Cyltezo was approved in August of 2017 and is currently the subject of litigation between Boehringer Ingelheim and AbbVie.

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