Katy bar the door - the FDA has just approved the first biologic generic anti-clotting factor from Momenta Pharmaceuticals (and Novartis). This is expected to be a spirited competitor to Sanofi-Aventis SA's Lovenox - a $4.57 B drug.
Momenta's shares soared 70% on the news and Sanofi-A'ventis' stock took a 5% hit. This approval might be seen as a harbinger that the FDA is going to be willing to assertively approve new biologics. While Momenta's drug is not genetically engineered, it is a complex biologic and this approval may signal how the FDA may view recombinant biologics when judging equuivalency.
Teva's Copaxone may be next on the list to be challenged by a biologic generic.
Posted by Bruce Lehr July 23rd 2010.