Biocon issued the following statement from subsidiary Biocon Biologics-

“The U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) for the Insulin-R product filed by Biocon Biologics. The CRL cites additional data required in the BLA submission and an expectation of a satisfactory implementation of a CAPA plan pertaining to the Pre-Approval Inspection of our Bangalore facilities in Aug'22. We are in the process of comprehensively addressing the CRL.” - Company Spokesperson, Biocon Biologics.

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Biocon will hold a meeting of the Board of Directors of the Company on 14 February 2023.

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In an exchange filing made after trading hours yesterday, the company said that it has been issued a good manufacturing practice (GMP) certificate of compliance by the European Directorate for the quality of medicines & healthcare (EDQM), for its active pharmaceutical ingredient (API) manufacturing facility in Bangalore.

This certification is based on a GMP inspection of the site that was conducted between the 12th and 14th of September 2022.

Biocon is an innovation-led, global biopharmaceutical company committed to enhancing affordable access to complex therapies for chronic conditions like diabetes, cancer and autoimmune diseases.

The company had reported a net profit (before exceptional items) of Rs 168 crore in Q2 FY23, down by 10% from Rs 188 crore in Q2 FY22. Revenue from operations increased by 26% YoY to Rs 2,320 crore during the quarter.

The scrip rose 0.57% to currently trade at Rs 271.15 on the BSE.

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Biocon announced the initiation of the clinical study of Itolizumab in patients with Ulcerative Colitis (UC) in India, in collaboration with Equillium Inc. This is a phase two randomized, double-blind, parallel-group, placebo and active-controlled (adalimumab), two treatment period study to evaluate the safety and efficacy of Itolizumab for the induction of remission in biologics naïve patients with moderate to severely active UC.

Having obtained approval from the Drugs Controller General of India (DCGI), the study will cover several tertiary hospitals specialized in handling UC cases. The first patient who intended to participate in the study was screened on 01 December 2022.

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