Biocon has finally satisfied the FDA that its insulin production plant in Malaysia is ready for prime time. The sign-off on the plant opens the way for a possible approval of the Lantus competitor developed with Mylan, which has been delayed in the U.S. for several years because of manufacturing questions.
Biocon reported (PDF) Wednesday the FDA has closed the pre-inspection of the plant for its insulin glargine, tagging the facility with a voluntary action indicated, a rating that indicates the facility meets at least the minimum FDA standards.
The finding follows a February inspection that resulted in a Form 483 with three observations. Biocon called the FDA decision “an endorsement of our commitment to global standards of Quality and Compliance.”
Mylan’s application for the knockoff of Sanofi’s blockbuster is currently before the FDA for review with a June target action date. Biocon and Mylan have won approval of their drug, branded Semglee, in Europe and some other markets, where it competes with other knockoffs.
It's been a long and bumpy road for the candidate, which has twice been sidelined by complete response letters because of the FDA’s concerns over the Malaysia plant. The second CRL was issued last August after the FDA tallied a dozen issues during a June pre-approval inspection of the three facilities that comprise the manufacturing operation for the drug.