Mylan NV must wait for certain issues at Biocon Ltd.'s production facilities in Malaysia to be resolved before the U.S. Food and Drug Administration decides to approve its application for insulin glargine, the regulator noted in a complete response letter.
Indian drugmaker Biocon is supposed to manufacture Mylan's generic diabetes medicine but ran into issues after the U.S. regulator observed certain violations at its facilities in Malaysia, the intended site to produce insulin glargine. Once approved, the drug will compete against Sanofi's Lantus.
Biocon noted in an Aug. 31 filing that the FDA did not identify any outstanding scientific issues with Mylan's application, and the medicine's approval is pending completion of corrective actions to be taken up by the Indian drugmaker at the Malaysian facility.
The timing of the commercial launch of insulin glargine in the U.S. is not expected to be impacted, Biocon said.
Separately, Biocon said the FDA noted four violations at its biologics drug product facility in Bengaluru, Karnataka, India, following an inspection between Aug. 22 and Aug. 30.
Biocon noted that the issues raised would not impact supplies from the facility and that it is working to address them.
