The US Food and Drug Administration (FDA) has issued an Establishment Inspection Report (EIR) to Biocon, a Bangalore, India-based pharmaceutical company, for its sterile drug-product manufacturing facility in Bangalore. The FDA’s inspection of the facility is now closed.

The EIR follows an FDA pre-approval inspection of the facility in April and May of 2018.

“Biocon is committed to global standards of quality and compliance,” Biocon said in a June 23, 2018 company statement.

In October 2017, the FDA issued a Complete Response Letter (CRL) to Biocon and Mylan over manufacturing issues for their biologics license application for a proposed biosimilar to Amgen’s Neulasta (pegfilgrastim), a drug to stimulate white-blood cell production after chemotherapy. The CRL related to the pending update of the BLA with certain chemistry, manufacturing, and controls data from facility requalification activities post recent plant modifications.

In July 2017, Biocon was cited by French regulatory authorities for good manufacturing practice deficiencies in the drug-product manufacturing plant that was to make pending biosimilars, including for biosimilars referencing Roche’s Herceptin (trastuzumab) and Amgen’s Neulasta (pegfilgrastim). While European regulatory authorities approved the drug-substance facilities for manufacturing trastuzumab and pegfilgrastim, regulators informed the company that there was a need for a reinspection of its drug-product manufacturing facility.

Source: Biocon