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Biocon scales record high after USFDA nod for biosimilar

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spurted 9.23% to Rs 487.75 at 10:05 on after the US drug regulator approved Mylan and Biocon's Ogivri, biosimilar for the treatment of HER2-positive breast and gastric cancers.

The announcement was made after market hours on Friday, 1 December 2017.

Meanwhile, the S&P Sensex was up 50.52 points, or 0.15% to 32,883.46.

High volumes were witnessed on the counter. On the BSE, 8.09 lakh shares were traded in the counter so far, compared with average daily volumes of 2.88 lakh shares in the past one quarter. The stock had hit a high of Rs 510 in intraday trade, which is also a record high for the stock. The stock had hit a low of Rs 483.85 so far during the day. The stock had hit a 52-week low of Rs 294.03 on 27 December 2016.

The stock had outperformed the market over the past one month till 1 December 2017, gaining 23.41% compared with the Sensex's 2.28% decline. The stock had also outperformed the market over the past one quarter, advancing 31.98% as against the Sensex's 2.95% rise. The scrip had also outperformed the market over the past one year, gaining 45.14% as against the Sensex's 23.62% rise.

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

Mylan N.V. and announced that the US Food and Drug Administration (USFDA) has approved Mylans Ogivri (trastuzumabdkst), a biosimilar to Herceptin (trastuzumab), co-developed with Ogivri has been approved for all indications included in the label of the reference product, Herceptin, including for the treatment of HER2-overexpressing breast cancer and metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma).

Ogivri is the first USFDA-approved biosimilar to Herceptin and the first biosimilar from Mylan and Biocons joint portfolio approved in the US. Mylan anticipates potentially being the first company to offer a biosimilar to Herceptin, as a result of Mylans ability to secure global licenses for its trastuzumab product from Genentech and Roche earlier this year. This milestone secured a clear pathway to commercialize Mylans biosimilar to Herceptin in various markets globally.

Mylan and Biocons biosimilar for Herceptin also is under review by regulatory authorities in Australia, Canada, Europe and several additional markets. It is already approved in 19 countries around the world, including India, thus providing increased access to this more affordable biologic for cancer patients.

Mylan is a global leader in the development and manufacturing of complex products, including biosimilar medicines, with a portfolio of 16 biosimilar and insulin analog products one of the industrys largest and most diverse portfolios.

Mylan and are exclusive partners on a broad portfolio of biosimilar and insulin products. Biosimilar for Herceptin is one of the six biologic products co-developed by Mylan and for the global marketplace. Mylan has exclusive commercialization rights for the product in the US, Canada, Japan, Australia, New Zealand and in the European Union and European Free Trade Association countries. has co-exclusive commercialization rights with Mylan for the product in the rest of the world.

Biocon's consolidated net profit fell 53.1% to Rs 68.80 crore on 2.4% increase in net sales to Rs 968.60 crore in Q2 September 2017 over Q2 September 2016.

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

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(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.)

First Published: Mon, December 04 2017. 10:11 IST
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