Biocon Biologics Receives Multiple Usfda Observations in India and Malaysia

By STI (Update)


Biocon’s subsidiary, Biocon Biologics, received several sightings at its facilities in Bengaluru and Malaysia. Has the company received such observations in the past? Read to find out more.

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

The USFDA conducted three on-site inspections of its subsidiary Biocon Biologics’ seven manufacturing facilities at two sites in Bengaluru and one in Johor, Malaysia.

The company said in an exchange filing that the inspections took place between Aug. 11 and Aug. 30.

Three pre-approval inspections of Biocon’s biosimilars Bevacizumab, rh-insulin and insulin aspart, as well as a capacity expansion inspection for trastuzumab triggered these inspections.

Biocon has highlighted the list of sightings the sightings relate to:

  • Need to improve microbial control strategies
  • Improve quality monitoring
  • Increase the use of software applications
  • Computerized tools to facilitate risk assessment and investigations and
  • Other procedural and facility upgrades
  • The company will submit the Corrective and Preventive Action Plans (CAPAs) to the USFDA on time.

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

    These USFDA observations come just weeks after the drug regulator reported quality and procedural deficiencies at Biocon’s facilities in Hyderabad. The Malaysian Insulin Aspart Unit also received six submissions from the USFDA in September last year.

    Management’s point of view

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

    “We will respond to these observations through a Corrective and Preventive Action Plan (CAPA) over 15 working days, which is the time frame provided by the agency, and we are confident that we can respond to their observations in a timely manner. timely,” he said.

    The company had signed an agreement with Viatris in February 2022 and says it is on track to complete the transaction by September this year.

    Biocon Biologics Receives Multiple Usfda Observations in India and Malaysia

    Shares of Biocon fell 3.5% at the open of trade before posting a slight rally from the opening lows. The stock is trading down 2% at Rs 303.70 as of 09:30.

    The stock is down 15% this year after falling 22% in 2021. Of the 21 analysts tracked by Bloomberg who cover Biocon, 62% have a “buy” recommendation while 19% each have a “keep” and “sell”. ” note, respectively.


    Not all news on the site expresses the point of view of the site, but we transmit this news automatically and translate it through programmatic technology on the site and not from a human editor.
    Back to top button