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- 01 Sep 2022
- ICICIdirect Research
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BICON RECEIVES USFDA OBSERVATIONS FOR BENGALURU, MALAYSIA FACILITY
BIOCON - 346 Change: 1.95 (0.57 %)News: USFDA conducted three on-site inspections of Biocon Biologics' seven manufacturing facilities spanning two sites in Bengaluru and one at Malaysia in August 11-30, 2022. These inspections were triggered on account of three pre-approval inspections for biosimilar Bevacizumab, rh-Insulin and Insulin Aspart and a capacity expansion inspection for biosimilar Trastuzumab. USFDA inspections included multiple drug substance and drug product facilities and other support infrastructure at these sites. USFDA has issued Form 483s with 11 observations each for the two sites in Bengaluru and six observations for the Malaysia site.
View: USFDA observations relate to the need for improving strategies for microbial control, enhancing quality oversight, augmenting the use of software applications & computerised tools to aid risk assessment & investigations and other procedural & facility upgrades. Biocon has said it will work on submitting corrective and preventive action plans (CAPA), to USFDA in the stipulated time and does not expect the outcome of these inspections to impact the current supply of the products. Biocon’s launches of bBevacizumab, bAspart and bAdalimumab, especially in the US, are expected to contribute to the near term growth of the business. With two strategic agreements signed with Serum and Viatris, Biocon is targeting revenues of ~US$ 1.8 billion in FY24. We believe timely regulatory clearance and subsequent launch timeline, notably for expected FY23 launches of bAspart (CRL in September,2021) and bBevacizumab remain key near term triggers for the company.
Impact: Negative.