Biocon scales record high as USFDA accepts BLA for proposed biosimilar Trastuzumab

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rose 3.46% to Rs 1,036.50 at 10:35 on after the company and its US partner Mylan said the US Food and Drug Administration has accepted the biologics licence application for its biosimilar drug to treat breast cancers.

The announcement was made after market hours yesterday, 11 January 2017.

Meanwhile, the S&P Sensex was up 91.67 points or 0.34% at 27,232.08

On the BSE, 1.64 lakh shares were traded on the counter so far as against the average daily volumes of 32,692 shares in the past one quarter. The stock hit a high of Rs 1,052.05 in intraday trade so far, which is record high for the counter. The stock hit a low of Rs 1,017.60 so far during the day. The stock had hit a 52-week low of Rs 430.80 on 12 February 2016.

The stock had outperformed the market over the past 30 days till 11 January 2017, rising 7.2% compared with 1.66% rise in the Sensex. The scrip also outperformed the market in past one quarter, gaining 6.62% as against Sensex’s 1.82% fall.

The large-cap company has equity capital of Rs 100 crore. Face value per share is Rs 5.

and Mylan N V announced that the US Food and Drug Administration (FDA) has accepted Mylan’s biologics license application (BLA) for MYL-1401O,a proposed biosimilar trastuzumab, for filing through the 351(k) pathway. This product is a proposed biosimilar to branded trastuzumab,which is indicated to treat certain HER2-positive breast cancers. The anticipated FDA goal date set under the Biosimilar User Fee Act(BsUFA) is 3 September 2017. Mylan and Biocon’s proposed biosimilar trastuzumab is also under review by the European Medicines Agency (EMA).

Mylan President Rajiv Malik commented that this is Mylan and Biocon’s first US regulatory submission through the 351(k) pathway and reinforces the strength of collaboration to increase access to a broad portfolio of high-quality, affordable biosimilars worldwide.

Dr Arun Chandavarkar, CEO and Joint Managing Director, Biocon, said it is a major milestone for the Mylan and collaboration since it is the first US regulatory submission through joint global biosimilars program.

reported consolidated net profit of Rs 146.70 crore in Q2 September 2016 as compared with net loss of Rs 10.60 crore in Q2 September 2015. Consolidated total income rose 21.3% to Rs 984.20 crore in Q2 September 2016 over Q2 September 2015.