Biotech Values

[DewDiligence]

Marth claims the ANDA is now at the FDA’s Office of Biotechnology Products (http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090470.htm ) to assess immunogenicity, and he implies that this means the drug has achieved sameness to branded Lovenox.

I don’t doubt that OBP has looked at or is looking at the application; what I do doubt is that OBP’s involvement signals that the product is approvable.