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.”
The whole episode is deja vu for Biocon and Mylan, which received a CRL for the product in June 2018 following an earlier preapproval inspection. In that case, the FDA asked for additional clinical data to support a request to manufacture the insulin injectors at the Malaysia facility instead of at a plant in Bangalore, India, that has had its own issues.
Biocon and Mylan have won approval of their drug, branded Semglee, in Europe and already launched it in England, but it competes in those markets with copies from Eli Lilly and Merck & Co.
While the further U.S. delay is a setback for Biocon and Mylan, it doesn’t mean much for Sanofi. That’s because sales of the French drugmaker’s top-selling drug have already been badly eroded by significant price discounting and by competition from Basaglar, the Lantus biosimilar Eli Lilly and Boehringer Ingelheim launched in the U.S. in 2016.
Sales of Lantus nosedived 19% to €3.95 billion in 2018 and were off another 16.7% to just €1.5 billion in the first half of this year.