In Europe, guidelines for the development of monoclonal biosimilars have been released for consultation and are expected to be finalised this year, providing clarity to manufacturers. In the US, there are currently no guidelines and the FDA is still mulling over the input that...
FDA finally wakes up to biologics and approves generic Lovenox
The FDA sprang a surprise last Friday and approved the first generic exnoxaparin (sanofi’s Lovenox), a low molecular weight heparin. Momenta and Sandoz’ application for this product has been pending for something like five years and although Lovenox was originally approved via the NDA...
What goes up must come down: FDA tells Hikma to get its colchicine off the market
The FDA announced yesterday that it would ban unapproved oral versions of the drug colchicine, some 14 months after it approved a version of the drug made by Mutual Pharma. As we discussed in detail in our report of September 21st, Hikma has been...