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“The committee voted 16-0 in support of eligible indications of the reference product, Herceptin®, which include HER2-positive breast cancer in the metastatic and adjuvant settings,” Biocon said in press release.
Biocon CEO and Joint Managing Director Dr. Arun Chandavarkar said, “We welcome ODAC’s endorsement of our biosimilar trastuzumab as it brings our collaboration a step closer to addressing the critical needs of cancer patients in the U.S. We now look forward to engaging with the FDA to seek final approval in order to expand access to a high-quality, affordable option for treating HER2-positive breast cancers.”
Mylan and Biocon's proposed biosimilar trastuzumab also is under review by regulatory authorities in Australia, Canada, Europe and several emerging markets, the company said.
In past four trading sessions, the stock of Biocon surged 26% as compared to 0.86% rise in the S&P BSE Sensex.
At 09:52 am; the stock was up 9% at Rs 399 against 0.19% decline in the benchmark index. The counter has seen huge trading volumes with a combined 8.99 million representing 4.5% of total equity of Biocon have changed hands in first 40 minutes of trade on NSE and BSE.