U.S. FDA Makes Eight Observations On Biocon’s Bengaluru Plant 

Shares of Biocon Ltd. fell as much as 6 percent in morning trade to its lowest level in three months on Wednesday, after the U.S. pharmaceutical watchdog made eight observations on the company’s Bengaluru plant, leading to worries over further delay in approvals.

The U.S. FDA had inspected the biotechnology major’s Bengaluru plant between March 27 and April 7, before issuing a Form-483 listing out these observations.

A Form 483 is issued when the U.S. FDA finds possible violations of the U.S. Food Drug and Cosmetic Act after an investigation.

Form 483 Observations For Biocon's Bangalore Plant:

• There are discrepancies between information submitted and manufacturing process performed
• Quality assurance unit allowed release of drugs with out of specification (OOS) results
• Handling of in-process samples is inadequate
• Lack of quality oversight in review of procedures followed in quality control testing
• Out of specification (OOS) procedure is internally inconsistent and not clear
• No adequate microbial control for solutions used for drug substance formulation
• Bioburden sampling is inadequate
• Deviations are not initiated or closed in time and do not include justifications for delays in closure

Biocon manufactures biosimilars at its Bengaluru plant, including a variant called Monoclonal Antibodies (MAbs). Trastuzumab is one such medicine which can be used to treat cancer and the company has filed for approvals to sell the product in Europe and the U.S. The latest observations made by the U.S. FDA could lead to a delay the approval process.

Biocon has been looking to ramp up its biosimilar division, as the company expects approvals to sell such medicines in regulated markets to start trickling in from the current financial year.

The U.S. pharma watchdog had accepted Biocon’s application seeking approval for Trastuzumab in the third quarter of financial year 2016-17. An application for another biosimilar called Pegfilgrastim was also accepted for review by the U.S. FDA in the fourth quarter of FY17.

The company has another biosimilar called Glargine, which it wants to sell in the U.S. and will be filing for approvals shortly.

The stock pared some of its initial losses, and was trading 2.9 percent lower at Rs 1,055.15 at 11.46 a.m.