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    Biocon gains after US drug regulator issues CRL to biosimilar

    The announcement was made before market hours today, 10 October 2017.

    Meanwhile, the S&P BSE Sensex was up 101.65 points or 0.32% at 31,948.54.

    On the BSE, 3.66 lakh shares were traded on the counter so far as against the average daily volumes of 4.47 lakh shares in the past one quarter. The stock had hit a high of Rs 361 and a low of Rs 347 so far during the day. The stock had hit a record high of Rs 424.15 on 19 July 2017 and a 52-week low of Rs 267.83 on 9 November 2016.

    The stock had underperformed the market over the past one month till 9 October 2017, advancing 0.42% compared with the Sensex`s 0.5% rise. The stock had, however, outperformed the market over the past one quarter, advancing 2.02% as against the Sensex`s 1.55% rise. The scrip had underperformed the market over the past one year, gaining 9.28% as against the Sensex`s 13.49% rise.

    The large-cap company has equity capital of Rs 300 crore. Face value per share is Rs 5.

    The US Food and Drug Administration (USFDA) has issued a complete response letter (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 does not expect this CRL to impact the commercial launch timing of biosimilar pegfilgrastim in the US. Biocon said it is committed to working with the agency to resolve the issues stated in the CRL expeditiously.

    On a consolidated basis, net profit of Biocon declined 51.2% to Rs 81.30 crore on 5.6% decline in net sales to Rs 927.40 crore in Q1 June 2017 over Q1 June 2016.

    Biocon is India`s largest and fully-integrated, innovation-led biopharmaceutical company.

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