The FDA has once again checked out the manufacturing plant where Biocon will make its challenger to Sanofi’s Lantus and once again it has come up short. The FDA tallied a dozen issues at the three facilities that comprise the manufacturing operation for the yet-to-be approved offering.
Biocon in a filing today with the Bombay Stock Exchange said the citations followed a two-week long pre-approval inspection of the insulin glargine drug substance, drug product and device assembly facilities in Malaysia.
The company did not say what problems were found but said it will respond to the Form 483 quickly. It says it does not expect the turn of events to affect its commercialization plans for the product in the U.S., which it will share with biosimilar partner Mylan.
Those plans, of course, have already been run into a number of detours. The FDA in June 2018 issued a complete response letter for the drug candidate after the first pre-approval inspection of the plant resulted in Form 483 with six observations.
The year before that, the FDA had concerns about Biocon’s plant in Bangalore, India, where it makes the autoinjectors for its insulin products. Biocon resolved those matters quickly but the partners are also still fighting with Sanofi over patents.
With all of the delays, analysts now believe the offering from Biocon and Mylan will not gain much traction against competition already in the market. Lilly and Boehringer Ingelheim launched their copycat, Basaglar, in 2016 under a patent settlement with the French drugmaker while Merck & Co. and Samsung Bioepsis last year ditched their effort as the market for Lantus and its rivals eroded.
That left Wells Fargo analyst David Maris to note at the time that Merck's decision did not bode well for Mylan and Biocon. “In our opinion, if Samsung Bioepis and Merck can't make the economics work, then one should be skeptical of Mylan and Biocon having substantial success,” he wrote at the time.