Replies to post #79390 on Biotech Values

[DewDiligence]

MNTA: My other point is that the EMEA/CHMP guidelines talks about efficacy and safety. It states that since a clear correlation between surrogate PD parameters (antifactor Xa or IIa) and clinical outcome has not been established, a similar biological medicinal product containing LMWH should show therapeutic equivalent to a reference product approved in the EU by at least one clinical trial.

This is no different from the EMEA guidance on any biosimilar—all you’re saying is that the EMEA has chosen to regulate heparin-based drugs as biologics rather than small molecules.

Since there are no FDA guidelines on the requirements for generic approval of a complex heparin mixture, a future guidelines may resemble that of the EMEA/CHMP.

Unlikely, IMO, for the reasons mentioned in my previous post. To reiterate, the EMEA does not have—and never has had—the charge of ruling on whether two drugs are to be substitutable; rather, this matter is regulated in the EU at the individual-country level. The FDA, on the other hand, is legally empowered to rule on substitutability and it does so implicitly every time an ANDA is approved. This fundamental distinction between the regulatory charge of the two agencies makes it unlikely that the agencies will end up with similar policies vis-à-vis generic heparin-based drugs.