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    US FDA asking for more data on insulin Aspart; no commercial impact of application rejection as of now: Biocon

    US FDA asking for more data on insulin Aspart; no commercial impact of application rejection as of now: Biocon

    US FDA asking for more data on insulin Aspart; no commercial impact of application rejection as of now: Biocon
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    By Sonia Shenoy   | Prashant Nair   | Nigel D'Souza   IST (Updated)

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    Biocon's application for its insulin Aspart has been rejected by US FDA. CNBC-TV18 spoke to Kiran Mazumdar Shaw, Executive Chairperson, Biocon, to gain more clarity and understand what it means for the company. Shaw believes the move won't have a commercial impact provided the data that is submitted by the company gets reviewed rapidly by the drug regulator. She explained that the company's plans for Asphalt were for the latter part of the calendar year.

    Biocon Biologics, a subsidiary of biotechnology major Biocon, on Friday, said the US health regulator has not approved an application for insulin Aspart filed by its partner Viatris Inc. Insulin Aspart is a biosimilar which is used to treat diabetes.
    "The USFDA has issued a complete response letter (CRL) for the biologics licence application (BLA) for insulin Aspart filed by our partner Viatris (Mylan)," a Biocon Biologics spokesperson said, in a regulatory filing.
    CNBC-TV18 spoke to Kiran Mazumdar Shaw, Executive Chairperson, Biocon, to gain more clarity and understand what it means for the company.
    Shaw explained that the USFDA has asked for additional process data from the company. The US drug regulator is of the view that the dossier submitted by the company is not complete. Additionally, Shaw explained that CRL is a part of regulatory approvals and right now, the company cannot set a timeline for the CRL but the hope is that the data submitted by the company will be reviewed rapidly.
    Shaw said, “Complete Response Letters (CRLs) are a regular part of the process of regulatory approval. So this is something which is of course for us disappointing, but it is integral to the regulatory process."
    She added, "They have requested us for additional information. They have also requested us for additional process data. So I think this is something that we are in a position to provide them with the earliest. Let us hope that they review and don't delay the approval for too long. So that is our expectation. So I can't really set a timeline for this CRL. But let us hope it's sooner than later.”
    On commercial plans for the insulin Aspart and the impact of the CRL, Shaw mentioned that there’s been no impact as such as the company was targeting the latter half of the year to launch its product.
    “Our commercial plans for Insulin Aspart were really in the latter half of this calendar year. So hopefully, if we get it before that, then it doesn't sort of impact our plans,” Shaw said.
    On insulin Glargine, she said, "We have just started introducing our interchangeable insulin Glargine and it is now the coming quarters that will actually show you how the uptick is happening. But we have seen a slight uptick in the last quarter, but it is not significant, but we expect it to really pick up in the coming quarters.”
    On inspection of their Malaysian plants for the drug Bevacizumab, she mentioned that the inspections for now are on hold and she doesn't expect them to be take place until the third wave of COVID is over. She said, “We were hoping that it would have been inspected by now but one wave after another of COVID seems to have delayed this inspection."
    "In fact, we have requested the FDA for even a remote inspection and even an inspection waiver if possible. But they have not really responded to that request. I don't expect inspection to happen until this wave is over and the coast is clear,” she added.
    Watch the video for the full interview.
    (With PTI inputs)
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