Replies to post #125382 on Biotech Values

[mouton29]

I think the FDA has now given a route-map to approval, and so subsequent entrants will have an easier time of it than MNTA did. The Amphastar disclosures added to my conviction on this.

It sounds like you don't regard MNTA's IP as an impediment. Also, which Amphastar disclosures are you referring to?

[iwfal]

I think the FDA has now given a route-map to approval, and so subsequent entrants will have an easier time of it than MNTA did

Anyone have any idea of the longest time between a company's first filing for a generic approval and when they actually got it?

[DewDiligence]

Generic Lovenox—You’re making a whale of an error in logic, IMO, by thinking that meeting the FDA’s five criteria for Lovenox sameness is sufficient for FDA approval of a substitutable Lovenox generic. In fact, meeting these five criteria is necessary for FDA approval, but nowhere does the FDA say that it is sufficient.

Unless an applicant can reverse engineer Sanofi’s production process (as NVS/MNTA have done), the FDA’s five criteria for Lovenox sameness are not especially helpful to an applicant who seeks an FDA-approved substitutable generic. That’s why no applicant other than NVS/MNTA has obtained FDA approval or is even close to obtaining it despite elapsed time of more than one year since the FDA published the Lovenox sameness criteria in Jul 2010.