Biosimilar giant Biocon gets hit with 483 for issues at sites in Malaysia and India

2022-09-02

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While Biocon continues to be one of the major players in the generics and biosimilars markets, several of the company’s manufacturing sites have ended up on the FDA’s radar. In a letter submitted to the stock exchange of India, Biocon stated that the FDA inspected three manufacturing facilities in the city of Bengaluru, India, and Johor, Malaysia. According to the letter, the inspections started with the Bengaluru site on Aug. 11 and concluded in Malaysia on Aug. 31. Biocon’s letter said that the inspections were due to three preapproval inspections for several biosimilars including bevacizumab, which is used to treat several forms of cancer, along with rh-insulin and insulin aspart, and a capacity expansion inspection for trastuzumab, another cancer treatment. Biocon said that the Form 483s had noted 11 observations each for the sites in Bengaluru along with six observations in Malaysia. The company said that the FDA’s observations are mainly related to improving microbial control, enhancing quality oversight, using more software and computer tools, facility upgrades and needing to implement other risk assessment tools. The company plans to submit an action plan to the FDA in the correct time frame. “We do not expect the outcome of these inspections to impact the current supply of our products,” a company spokesperson said in a statement . This is not the first time Biocon, and the FDA have crossed paths. Last year a Form 483 showed several issues that included an unqualified distribution system, inadequate aseptic monitoring and leaky drains, among other issues at one of its subsidiaries in Malaysia. In April, Biocon netted an insulin supply deal with the government of Malaysia, with the contract being valued at $90 million. The 483 also comes as Biocon shelled out $3.3 billion earlier this year to buy out Viatris’ biosimilars business, giving the company a new revenue stream in the process. However, Biocon is not alone in receiving scrutiny from the FDA. This year several major Indian manufacturers such as Aurobindo , Sun Pharma , Cipla and Cadila have all been hit with 483s for various infractions at manufacturing sites in the subcontinent.

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