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FDA Clears Biocon's Insulin Factory in Malaysia


After a number of issues raised by the FDA about plant quality, Biocon has gotten clearance for its Malaysia insulin plant and now awaits FDA marketing authorization for Semglee, its insulin glargine agent.

After a few years struggling with quality issues at its new Malaysia plant, Biocon appears to be closer to getting its insulin glargine (Semglee) product on the market in the United States. The company announced that the FDA noted only voluntary improvements needed on the latest inspection of the facility.

This follows earlier receipt of Complete Response Letters and Form 483 notices, which indicate that essential improvements are needed to allow production.

The resolution of those issues and the just-announced plant clearance represent “an endorsement of our commitment to global standards of quality and compliance,” the company said in a release.

The latest inspection, in February 2020, appears to have come under the wire for Biocon, as in March the FDA announced that it would suspend foreign site inspections as a result of the coronavirus 2019 (COVID-19) pandemic.

“The inspection has been closed with a Voluntary Action Indicated classification in the Establishment Inspection Report,” Biocon said in a release.

“The closing of the USFDA Inspection of our Malaysia facility is an important milestone in our journey of developing insulin glargine for patients in the United States,” Biocon said.

The company has partnered with Mylan in the effort to bring the biologic to market. Mylan has previously filed an application for the product with the FDA under the 505(b)(2) new drug application pathway under the FD&C Act. Under a change in the Biologics Price Competition and Innovation Act, insulin applications will be reviewed as biologic license applications under section 351 of the Public Health Service Act.

The insulin glargine product is already authorized in the European and Australian markets, where it is sold under the brand name Semglee.

In 2019, the Malaysia plant received a certificate of good manufacturing practice from the European Medicines Agency’s Irish inspection authority.

The effort to get the Malaysia plant approved for production was the result of a manufacturing site change from Bangalore.

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