BioCentury
ARTICLE | Politics & Policy

FDA bioequivalence guidance includes Copaxone, Iressa

April 15, 2016 12:08 AM UTC

FDA released a batch of new and revised product-specific guidances describing how manufacturers of generic drugs can establish bioequivalence to their reference products. The guidances include recommendations for multiple sclerosis therapy Copaxone glatiramer acetate from Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) and lung cancer drug Iressa gefitinib from AstraZeneca plc (LSE:AZN; NYSE:AZN).

In the Copaxone draft guidance, FDA says ANDA manufacturers should use four criteria to demonstrate the API's sameness: equivalence of fundamental reaction scheme, physicochemical properties including compositions, structural signatures for polymerization and depolymerization, and biological assay results. ...