Daily Archives: November 8, 2007

Immunogenicity and Follow-on-Biologics

This week, the FDA issued a non-approvable letter to Momenta Pharmaceuticals as outlined in a press release from the company.   The approvable letter was issued to Momenta and its partner, Sandoz, Inc, which is a generics manufacturing division of Novartis.  … Continue reading

Posted in Biologics | 4 Comments