Replies to post #101691 on 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.

[bladerunner1717]

Mouton and Zipjet,

What are the criteria by which the FDA determines whether a drug is "fully substitutable" or not? How are those criteria different from a drug approved as a "not fully substitutable" generic?

If a drug is approved as a generic, but not a "fully substitutable" generic, then how do we refer to this drug (as opposed to how we would refer to the fully substitutable drug)? Branded generic?

Does a drug that is approved as a generic, but not a "fully substitutable" generic have to undergo any clinical testing?

Do you happen to know whether the generics approved for Wellbutrin XL were approved as fully substitutable or not?

Would a physician be less likely to prescribe a generic drug, if s/he knew that the drug had been approved as a "not fully substitutable" drug?

Does a patient generally know whether a generic has been approved as "fully substitutable" or "not fully substitutable?" (I understand that a pharmacist can fill the prescription anyway that s/he wants, if the drug has been approved as "fully substitutable." I assume the treating physician can write the prescription for the branded original, if s/he has any doubts about the efficacy and/or safety of the approved generic, whether it's been approved as "fully substitutable" or not.)


Bladerunner


Bladerunner