Eye on Pharma: Biocon's Insulin Facility Earns GMP Certification

Biocon has gained a certificate of good manufacturing practice (GMP) from the European Medicines Agency’s Irish inspection authority for its Malaysian manufacturing site where it produces its insulin glargine biosimilar, Semglee, referencing Lantus.

The site was inspected in May 2019, according to Biocon. The company indicated in a statement that the approval will allow the company to expand its capacities with new large-scale devices as it seeks to meet the growing demand for insulins in Europe, where the biosimilar has been authorized for sale since March 2018.

Since its authorization by the European Commission, the biosimilar, developed in partnership with Mylan, has become available in key markets that include the United Kingdom. The biosimilar is also approved in other major regulatory territories, including Australia.

Semglee is not yet approved in the United States, however, where the product received a Complete Response Letter (CRL) from the FDA in 2018 after having been evaluated under the 505(b)(2) regulatory pathway for follow-on drugs (as insulins and some other biological products will not be regulated as biologics in the United States until March 2020).

At the time of the CRL, a Mylan representative told The Center for Biosimilars^® that the partnership had agreed with the FDA to provide additional clinical data in support of a manufacturing site change from Bangalore to Malaysia and that the companies had incorporated the CRL into their plan.

Prior to the CRL, the company received a Form 483 from the FDA, inclusive of 6 observations, after an inspection of the Malaysia facility. Another inspection of the site in June and July 2019 yielded another Form 483 with 12 observations. Biocon indicated that it will respond with a corrective and preventive action plan.