FDA Committee Recommends Two Biosimilars

Jul 14, 2016

Biosimilars to Humira and Enbrel are one step closer to the marketplace with FDA advisory committee approval.

This week, the U.S. Food and Drug Administration's Arthritis Advisory Committee recommended the approval of a biosimilar product to Humira (adalimumab) for the treatment of rheumatoid arthritis and moderate to severe plaque psoriasis.

The biosimilar, ABP 501 (Amgen), was determined to be highly similar to adalimumab in terms of safety and efficacy. The FDA panel voted unanimously in favor of recommending its approval.

However, AbbVie, the maker of Humira, indicated that it would attempt to block the Amgen’s biosimilar product from production by claiming patent infringement.

Humira is approved for rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis and a chronic skin condition called hidradenitis suppurativa. It is also used to treat Crohn's disease or ulcerative colitis.

Reuters reportedthat the FDA panel concluded that clinical trial results could be extrapolated to other conditions for which Humira is approved and should be approved for those conditions too, a recommendation that concerns patient advocacy groups like CreakyJoints which questioned the safetyof such a measure. CreakyJoints and other groups urged the FDA to require post-market surveillance studies on the biosimilar product since it hasn’t yet been studied in all conditions for which Humira has been approved.

The FDA advisory committee voted to approve the Sandoz/Novartis biosmilar to Amgen’s Enbrel (etanercept) for all original indications:  rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis and plaque psoriasis.

 

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