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Copaxone And Complex Generics: Difficult-To-Copy Does Not Mean Impossible

 
• By Cole Werble

FDA’s approval of the first ANDA for an MS therapy signals the agency’s determination to find a way to get generic versions of complex drugs to market. What if any lessons does that hold for biosimilars?

FDA’s approval of Sandoz Inc./Momenta Pharmaceuticals Inc. generic glatiramer acetate (Glatopa) reiterates the agency’s determination to find a way to approve copies of complex, difficult-to-copy drugs.

That’s the foundational message from the April 16 approval, and from the very substantive, simultaneous rejection

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