Biocon hit with multiple 483s

Sept. 2, 2022

Biocon, India's biggest biopharma, has revealed that the U.S. FDA has issued three Form 483s following inspections of the manufacturing facilities of its Biocon Biologics arm.

The agency conducted three on-site inspections of Biocon Biologics’ facilities, spanning two sites in Bengaluru, India and one in Johor, Malaysia. The inspections started with the Bengaluru site on August 11, 2022 and concluded with the Malaysia site on August 30, 2022.

Biocon was then issued Form 483s with 11 observations each for the two sites in Bengaluru and six observations for the plant in Johor.

According to the drugmaker, the observations primarily relate to the need for improving strategies for microbial control, enhancing quality oversight, augmenting the use of software applications and computerized tools to aid risk assessment and investigations and other procedural and facility upgrades.

Biocon said the inspections were part of the pre-approval process for its biosimilar to Roche's Avastin (bevacizumab) and two insulins.  One of the inspections was related to capacity expansion for the manufacturing of a biosimilar to Roche's Herceptin (trastuzumab).

The 483s come just months after Biocon acquired Viatris' global biosimilars business with the stated goal of becoming a fully integrated biosimilars enterprise. Biocon said it will submit CAPA plans to the FDA in the stipulated time frame.