Biocon rose 3.20% to Rs 679.50 at 11:04 IST on BSE after CHMP issued a positive opinion recommending approval of Ogivri, a biosimilar to Roche's Herceptin.
The announcement was made after market hours on Friday, 19 October 2018.Meanwhile, the S&P BSE Sensex was up 91.24 points, or 0.27% to 34,406.87.
On the BSE, 1.25 lakh shares were traded in the counter so far compared with average daily volumes of 1.48 lakh shares in the past two weeks. The stock had hit a high of Rs 683 and a low of Rs 668 so far during the day. The stock hit a record high of Rs 718.35 on 26 September 2018. The stock hit a 52-week low of Rs 343.50 on 27 October 2017.
Biocon and Mylan N.V. announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of Ogivri, a biosimilar to Roche's Herceptin (trastuzumab). The CHMP positive opinion will now be considered by the European Commission.
The decision on approval is expected by the end of 2018. Ogivri is indicated for treatment of patients with HER2 positive early breast cancer (EBC), metastatic breast cancer (MBC) and metastatic gastric cancer (MGC). Under supervision of the relevant healthcare professional it can be prescribed as either monotherapy or in combination with other medicines dependent on the relevant diagnosis.
Ogivri was approved by the US Food and Drug Administration (FDA) in 2017 and is the first FDA-approved biosimilar for Herceptin in the US Additional regulatory approvals have been secured in 35 countries around the world.
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Herceptin had brand sales of approximately $1.9 billion in Europe for the 12 months ending 31 July 2018, according to IQVIA.
Mylan and Biocon are exclusive partners on a broad portfolio of biosimilar and insulin products. Ogivri is one of 11 biologic and insulin products co-developed by Mylan and Biocon 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. Biocon has co-exclusive commercialization rights with Mylan for the product in the rest of the world.
On a consolidated basis, Biocon's net profit rose 47.23% to Rs 119.70 crore on 21.18% increase in net sales to Rs 1123.80 crore in Q1 June 2018 over Q1 June 2017.
Biocon is a fully-integrated, innovation-led global biopharmaceutical company.
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