Biocon rises on receiving CRL from USFDA for proposed Biosimilar Pegfilgrastim

10 Oct 2017 Evaluate

Biocon is currently trading at Rs. 351.00, up by 7.15 points or 2.08% from its previous closing of Rs. 343.85 on the BSE.

The scrip opened at Rs. 350.70 and has touched a high and low of Rs. 355.60 and Rs. 347.00 respectively. So far 47,000 shares were traded on the counter.

The BSE group 'A' stock of face value Rs. 5 has touched a 52 week high of Rs. 424.15 on 19-Jul-2017 and a 52 week low of Rs. 267.57 on 09-Nov-2016.

Last one week high and low of the scrip stood at Rs. 355.60 and Rs. 333.15 respectively. The current market cap of the company is Rs. 21,180.00 crore.

The promoters holding in the company stood at 60.67%, while Institutions and Non-Institutions held 18.80% and 20.53% respectively.

Biocon has received a Complete Response Letter (CRL) from the US Food and Drug Administration (USFDA) for proposed Biosimilar Pegfilgrastim. USFDA has issued a CRL for Mylan’s Biologics License Application (BLA) for MYL-1401H, a proposed biosimilar pegfilgrastim. This product is a part of the biosimilars portfolio being developed jointly by Biocon and Mylan.

The CRL relates to the pending update of the BLA with certain CMC data from facility requalification activities post recent plant modifications. The CRL did not raise any questions on biosimilarity, pharmacokinetic/pharmacodynamic data, clinical data or immunogenicity.

Biocon is India’s largest and Asia’s leading Biotechnology Company with a strategic focus on biopharmaceuticals and research services. It is a fully integrated, innovation-driven biopharma enterprise offering affordable solutions for chronic diseases to patient's worldwide.


Biocon Share Price

384.05 -8.75 (-2.23%)
08-Dec-2025 16:59 View Price Chart
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