Biocon buzzes on details of USFDA observation

The stock of Biocon was buzzing as the details about the inspection of the company's Bengaluru unit which is crucial for the planned launch of three biosimiliars reaches the market.

The company has assured investors through a communication that it will addrss the concern of the USFDA in a timely manner. The US pharma regulator completed a pre-approval inspection of their manufacturing facility in Bengaluru and issued a Form 483 with 7 observations. The inspection was conducted between April 23 and May 1. The observations demand for corrective and procedural improvements of the company's sterile drug product manufacturing facility.

Approvals for Biocon's three major biosimilar products Trastuzumab, Pegfilgrastim and insulin Glargine are expected in the FY19.

On Friday, at 10:26 hours, Biocon Limited was quoting Rs. 636.45 per share, down by 52 per cent on BSE. The stock has witnessed a fall of 0.91 per cent in the last two days.