USFDA approves production of Biocon biosimilar at new Bengaluru unit

The US Food and Drug Administration's (USFDA's) nod to Biocon's supplemental biologics licence application for the new unit will expand the company's capacity multifold, the company said

Biopharmaceutical major Biocon on Wednesday received approval from the US health regulator to manufacture biosimilar Pegfilgrastim at its new drug substance facility in Bengaluru. Manufacturing at the plant starts immediately after the approval as per regular Good Manufacturing Practices SoPs (standard operating procedures), said a company spokesperson.

The US Food and Drug Administration’s (USFDA’s) nod to Biocon’s supplemental biologics licence application for the new unit will expand the company’s capacity multifold, said the Bengaluru-headquartered firm.

“This is a significant milepost in our journey of serving five million patients by FY22 and crossing a revenue milestone of $1 billion. This approval