Mylan's Lantus copy derailed in U.S. again by manufacturing ills
When Biocon’s insulin operations in Malaysia won EU approval two weeks ago, it sounded like the company had turned a quality corner. But that turn is not near sharp enough for the FDA, which has issued a second complete response letter (CRL) for the Lantus competitor Biocon developed with Mylan.
Biocon announced over the weekend that the FDA had issued the CRL to Mylan for the drug approval “pending completion” of improvements at Biocon’s facilities in Malaysia. It was not a big surprise given that the FDA tallied a dozen issues at the three facilities that comprise the manufacturing operation for the drug during a preapproval inspection in June.
“The CRL did not identify any outstanding scientific issues with the application,” Biocon said (PDF) in a public filing. “We remain confident of the quality of our application and do not anticipate any impact of this CRL on the commercial launch timing of our Insulin Glargine in the U.S.”