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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.

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