Biotech Values

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MNTA: FDA denied TEVA citizen petition and approved generic Copaxone based on 4 criteria

Based on our current understanding of the product, its indication and its mechanisms of action, this can be accomplished by showing equivalence between the ANDA product and RLD as to the following criteria:

1. Fundamental reaction scheme;
2. Physicochemical properties including composition;
3. Structural signatures for polymerization and depolymerization; and
4. Results in a biological assay.

These four criteria take into account the inherent molecular diversity associated with glatiramer acetate and, taken together, are designed to provide overlapping and confirmatory evidence of active ingredient sameness through which FDA can conclude that generic glatiramer acetate injection has the same active ingredient as Copaxone.

http://www.regulations.gov/contentStreamer?documentId=FDA-2015-P-1050-0012&attachmentNumber=1&disposition=attachment&contentType=pdf