Biocon confident of approval for Lantus copy after Malaysia plant inspected by FDA a 3rd time

Biocon Malaysia insulin plant
Biocon says a pre-approval inspection of its insulin manufacturing facility in Malaysia resulted in three observations, much improved over an inspection last year that led to a complete response letter for the competitor to Sanofi's Lantus that Biocon has developed with Mylan. (Biocon)

With a new target date fast approaching for its competitor to Lantus, Biocon’s insulin manufacturing plant in Malaysia has again been given a once over by the FDA. While the agency nicked it with three observations, the Indian company is confident of getting the product to market this time.

Biocon in a financial filing said (PDF) that the FDA issued a Form 483 with three observations after the pre-approval inspection for its insulin glargine product. The inspection, which began February 10, concluded last Friday, February 21. The target action date is set for June. 

Biocon said it is responding with a corrective and action plan and is confident of addressing the observations "expeditiously."   

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"We believe the outcome of this inspection does not in any way impact the commercialization plans of insulin glargine in the U.S." the biosimilars maker said in the filing.

That was not the case following two earlier pre-approval inspections, both of which led the FDA to issue complete response letters to Biocon partner Mylan for the drug. Last year, the FDA noted a dozen observations at the three facilities that comprise the manufacturing operation for the drug. 

Biocon and Mylan have won approval in Europe of their drug, branded Semglee. If approved by the FDA, Semglee will compete in the U.S. with a biosimilar from Eli Lilly and Boehringer Ingelheim. They launched their competitor to Sanofi's blockbuster Lantus in 2016.