Biocon insulin operation gets FDA nod, paving way for approval of Lantus knockoff

Biocon insulin operation gets FDA nod, paving way for approval of Lantus knockoff

Source: 
Fierce Pharma
snippet: 

Biocon has finally satisfied the FDA that its insulin production plant in Malaysia is ready for prime time. The sign-off on the plant opens the way for a possible approval of the Lantus competitor developed with Mylan, which has been delayed in the U.S. for several years because of manufacturing questions.