1. Generics Bulletin

US Ruling Confirms Copaxone Is Not A Biologic

Legal Fight May Finally Be Over After District Court Ruling

 
• By Brenda Sandburg

US FDA’s interpretation of ‘protein’ is reasonable and owed deference, the court concludes in tossing Teva suit which challenged Copaxone’s exclusion from list of drugs transitioned to being regulated as biologics.

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District court dismisses Teva's suit against FDA over Copaxone designation • Source: Shutterstock

The long saga of Teva’s fight to block additional Copaxone (glatiramer acetate) competitors from entering the market appears to have come to an end with a district court ruling that the US Food and Drug Administration reasonably determined that the multiple sclerosis treatment is not a biologic.

Teva filed suit against FDA last year challenging its decision to exclude Copaxone from a list of 96 new drug applications transitioned from being regulated as drugs to being regulated as biologics. The products on the transition list included insulins, human growth hormone and certain other types of protein products. The agency concluded that Copaxone does not have a specific, defined sequence of amino acids and is therefore not a biological product

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