FDA slaps Biocon following inspections of biosimilar production sites in India, Malaysia

In an apparent move to enforce biosimilar quality requirements, the FDA hit Biocon Biologics with multiple Forms 483 (PDF) following an inspection spree of the drugmaker’s manufacturing operations in two countries.

The regulatory agency conducted three on-site inspections of Biocon Biologics’ production plants in two sites in Bengaluru, India, and one facility in Johor, Malaysia, from Aug. 11 through Aug. 30 this year, the company said.

Inspectors cited 11 observations at each of the sites in India and six observations at the Malaysian plant.

“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,” the company said in a statement.

The inspections were part of the agency's preapproval requirements for Biocon Biologics' biosimilar to Roche cancer treatment Avastin and two insulins. Inspectors also reviewed a proposed capacity expansion for Biocon's Herceptin biosimilar.

The company said it will initiate corrective plans in response to the FDA citations but does not expect the inspections to have an impact on supplies.

Biocon Biologics is a subsidiary of Indian drugmaker Biocon. Back in February, the company scooped up Viatris' biosimilar franchise for $3.3 billion.

Biocon, which has been part of a wave of manufacturers scrambling to produce new insulin treatments, was hit with a bribery scandal in June when India’s Central Bureau of Investigation arrested an Indian regulator and four Biocon employees, including an associate vice president.

The law enforcement agency alleged Biocon agreed to pay the regulator about $11,500 to waive a phase 3 clinical trial of its insulin aspart injection, which treats of Type 1 and Type 2 diabetes. The company has denied the allegations.