Teva Sues FDA For Excluding Copaxone From BLA Transition; Wants To Use Biosimilar Litigation Process

Teva and US FDA disagree over whether Copaxone is a protein. While generics are already on the market, Teva wants to assert process patents against future would-be competitors, which the firm cannot do through the ANDA pathway.

Medical needles of Copaxone — Teva Wants Copaxone To Be Deemed A Biologic

The day after the US Food and Drug Administration switched nearly 100 new drug applications from being regulated as drugs to biologics, Teva Pharmaceuticals USA Inc. filed suit against the agency for excluding Copaxone (glatiramer acetate injection) from the transition list. While generics of the multiple sclerosis treatment are already on the market, Teva would like to use the biosimilar litigation process to prevent further generics from launching.

The complaint, filed on 24 March in the US District Court for the District of Columbia, says that had...