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Shares of Biocon jumped as much as 16.3 per cent to hit a record high of Rs 510 on US FDA approval for generic cancer drug Ogivri.
Following a positive open at Rs 491.20 against the previous close of Rs 446.55, the scrip touched an intraday high of Rs 519.50 and a low of Rs 483. In terms of equity volume, 25.1 lakh shares exchanged hands in the evening trade.
The stock ended higher by 15 per cent at Rs 513.55 on the BSE. On the NSE, the stock closed up 15.6 per cent at Rs 517,
“Biocon and Mylan have a shared commitment to enhance access to cutting-edge bio-therapeutics and this approval will enable us to provide an affordable alternative for cancer care that will address the unmet needs of patients in the US,” Biocon CMD Kiran Mazumdar-Shaw said.
Mylan and Biocon’s biosimilar for Herceptin is also under review by regulatory authorities in Australia, Canada, Europe and several additional markets, the statement said.
It is already approved in 19 countries around the world, including India, thus providing increased access to this more affordable biologic for cancer patients, it added.
Mylan CEO Heather Bresch said: “The approval of Ogivri represents a monumental achievement for Mylan to increase patient access to biosimilars and deliver significant savings to the US healthcare system.”
The US Food and Drug Administration had on Friday approved Mylan NV's biosimilar of Roche's blockbuster treatment for breast cancer, Herceptin, making it the second copycat cancer drug to be approved in the United States.
The FDA said Mylan's drug Ogivri, which was co-developed with Biocon, was the first biosimilar approved in the United States to treat breast or stomach cancer.
This is the first US/EU biosimilar approval for the partnership, allaying concerns over compliance with manufacturing standards, potentially paving the way for Biocon's biosimiliar of chemotherapy drug Neulasta in Q1 2018, according to Kotak Securities analysts.
Analysts say that while the approval marks a watershed moment for Biocon, the focus should shift to commercials, with biosimilar Herceptin likely to turn into a four-five player market by H1 2019.
More than 8.4 million shares traded, 2.6 times their 30-day moving average of 3.2 million shares. Up to Friday's close, the stock had gained 41.3 per cent this year.
(With inputs from agencies)
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