Biotechnology major Biocon's subsidiary Biocon Biologics has received multiple observations across its production facilities in India and Malaysia from the US Food and Drug Administration (USFDA).

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The regulator has issued Form 483s with 11 observations each for the two Bengaluru sites and six observations for the Malaysian facility.

The USFDA conducted three onsite inspections of its subsidiary Biocon Biologics' seven manufacturing facilities across two sites in Bengaluru and one at Johor in Malaysia.

The company said in an exchange filing that the inspections happened between August 11 and August 30.

Three preapproval inspections for Biocon's biosimilar Bevacizumab, rh-Insulin, and Insulin Aspart, along with a capacity expansion inspection for Trastuzumab triggered these inspections.

Biocon has highlighted the list of observations that the observations pertain to:

Need to improve strategies for microbial control

Enhancing quality oversight

Augmenting the use of software applications

Computerized tools to aid risk assessment & investigations and

Other procedural and facility upgrades

The company will submit the Corrective and Preventive Action Plans (CAPA) to the USFDA in the stipulated time frame.

"We do not expect the outcome of these inspections to impact the current supply of our products," the company mentioned in its exchange filing.

These USFDA observations come just a few weeks after the drug regulator flagged quality and procedural lapses at Biocon's Hyderabad facility. The Malaysian unit for Insulin Aspart also received six observations from the USFDA in September last year.

Management's Take

Shreehas Tambe, Deputy CEO of Biocon Biologics told CNBC TV 18 that the company will respond to the inspection within 15 days and that there is no delay in the approval timelines.

"We will respond to these observations through Corrective And Preventive Action (CAPA) plan over 15 working days, which is the timeframe that is provided by the agency, and we are confident of being able to respond to their observations in these timely manner," he said.

The company had signed a deal with Viatris in February 2022 and it says it is on track to close the transaction by September this year.

Shares of Biocon fell as much as 3.5 percent in opening trade before staging a slight recovery from the opening lows. The stock trades 2 percent lower at Rs 303.70 as of 9:30 AM.

The stock is down 15 percent this year after a 22 percent drop in 2021. Out of the 21 analysts tracked by Bloomberg who cover Biocon, 62 percent of them have a "buy" recommendation while 19 percent each have a "hold" and "sell" rating, respectively.

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First Published:Sept 1, 2022 8:54 AM IST