Teva Calls on FDA to Make Copaxone a Biologic as Part of March Transition

Beginning 23 March, the US Food and Drug Administration (FDA) is going to convert more than 100 medicines approved under new drug applications (NDAs) to biologics license applications (BLAs) because the Biologics Price Competition and Innovation Act of 2009 and the recent appropriations law broadened the scope of “biological product” to include any protein, including chemically synthesized polypeptides.

Ahead of this switch, FDA published a list of the drugs making this transition, but generic drugmaker Teva Pharmaceuticals is now calling on the agency to add its multiple sclerosis drug Copaxone (glatiramer acetate), which it says is “noticeably absent from this list.”