FDA Approves 7th Biosimilar to Humira – Yusimry

At the end of December, the FDA approved yet another biosimilar, Yusimry (adalimumab-aqvh) from Coherus Bioscience. Yusimry is a tumor necrosis factor blocker approved as a subcutaneous formulation. It is indicated for plaque psoriasis, psoriatic arthritis, rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, Crohn’s disease, and ulcerative colitis.

Yusimry is the seventh biosimilar to be approved for AbbVie’s blockbuster Humira (adalimumab).

This approval marks the thirty third (33) biosimilar in the US and the 7th biosimilar to Humira. None of the Humira biosims are currently available for sale in the US. Per the terms of its agreement with AbbVie, Coherus (as with the others) will launch in the U.S. in July of 2023.

Last year was a lean year for new biosimilar approvals….. only four products. That compares poorly compared with 2019 when 10 biosimilars were approved.

Pricing for Yusimry is unlikely to be released until the product is close to its 2023 launch date.

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