Biotech Values

[DewDiligence]

Corollary of Sandoz’s reply vis-à-vis Teva:

…according to FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, also known as the “Orange Book,” a therapeutic equivalence rating is available for any FDA-approved drug product so long as it has made the necessary showing. Thus, the criteria by which FDA may assign therapeutic equivalence clearly does not depend on the regulatory pathway chosen, but rather on scientific determinations of equivalence that FDA can make.

If Sandoz’s argument is valid, it follows that a drug approved under 505(j) could conceivably be non-substitutable for the branded product, which is apropos to the speculation on this board about Teva (#msg-43206942).

p.s. It’s somewhat disturbing to see NVS’ lawyers use the word criteria as a singular noun.