Biotech Values

[DewDiligence]

MNTA/TEVA/MYL—In the Copaxone appellate-court document the amino-acid content of generic glatiramer acetate of both Momenta and Mylan are mentioned on Page 18. The numbers are quite different, especially in the case of Tyrosine (8.3% vs. 9.2% respectively which is a ~10% deviation). Does this mean that the similarity required by the FDA has some flexibilities?

There is clearly some flexibility in the FDA’s standard of sameness or no generic for a complex molecule would ever be approved; however, the differences you cited in the court documents may be consequential.

As far as I know, MYL did no development work on its generic-Copaxone product, so MYL’s ANDA is based on the Copaxone knockoff that Natco sells in India and Ukraine (#msg-29902618). Still, I don't think MYL's Copaxone ANDA is a hoax in the sense that Teva's Lovenox ANDA was.