Biocon Biologics May See Delay In Key Launches On U.S. FDA Observations

Biocon in the filing disclosed that the observations were primarily related to “the need for improving strategies for microbial control, enhancing quality oversight, augmenting the use of software applications and computerised tools to aid risk assessment and investigations and other procedural and facility upgrades”.

The company said it would submit corrective and preventive action plans to the U.S. FDA in the stipulated time frame, and doesn’t expect the outcome of these inspections to impact the current supply of its products.

Biocon has declined to comment on BQ Prime’s emailed queries on expected timelines for resolution of the issues, corresponding delay and new timelines for the potential launch of these products, the market potential of these launches and the loss due to delay.

Vishal Manchanda, pharma analyst at Systematix, told BQ Prime that “Insulin Aspart, which is to be launched from the company’s Malaysian facility, is an important potential launch for the company in the U.S.”

The current expectation was a CY22-end launch. But with the Malaysian facility receiving fresh observations, there is a potential chance for the approval timelines getting extended, he said. That could push back the launch.

The approval for this biosimilar has seen a delay in the past on account of a complete response letter that Biocon had received from the U.S. FDA, Manchanda said.