USFDA recommends approval of Biocon’s breast cancer biosimilar
Mumbai: Mylan and Biocon Ltd. NV, based in Bangalore, said on Friday that the United States Food and Drug Administration’s advisory committee on cancer drugs recommended the approval of its biosimilar trastuzumab, indicated for The treatment of breast cancer.
Based on data provided by Mylan, Biocon for its biosimilar trastuzumab, the committee determined that there were no clinically significant differences between the biosimilar product and innovation Herceptin drugs Roche Holding AG in terms of safety, purity and power, and concluded that The evidence supports a FDA approval recommendation.
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Biosimilars are a type of organic product that shows significant differences from an existing product and licensed non-clinically.
“The committee voted 16-0 in favor of eligible indications of the reference product, Herceptin, which included HER2 positive breast cancer in adjuvant and metastatic configuration,” said the companies in a joint statement.
This made the development shares in Biocon to an unprecedented level of RS404 in intraday trading. So far, in 2017, the population increased by 25%. At 11:35, the company’s shares were up 7.9% at Rs395.75 on BSE, while the Sensex benchmark fell 0.2% to 31,970.03 points.
The FDA uses committees and charts to obtain advice from independent experts on various topics, including product approvals.
“This is a great positive for Biocon.Now, there is only one obstacle to the approval of the resolution observations to the Bangalore plant, which the company believes to solve.” The company is already installed with an innovative start-up in the mid 2019. The key thing to note is the number of players again until mid-2019. Five players are in the queue, “said Edelweiss Securities Ltd.
The company said in May that it had answered questions about violations of factory rules in time.
“We look forward to working with the FDA to obtain final approval to expand access to the affordable and high-quality option to treat HER2-positive breast cancer,” said Arun Chandavarkar, Biocon’s chief management officer and joint management director. In the statement Friday.
The biosimilar trastuzumab proposed by Mylan and Biocon is also reviewed by regulatory authorities in Australia, Canada, Europe and several emerging markets.
Earlier this week, Biocon had said that the National Medicines Agency and Health Product Safety on behalf of the European Medicines Agency (EMA) carried out a preliminary inspection of the control units manufacturing drugs and related drugs To applications filed with the European regulator for trastuzumab and pegfilgrastim biosimilar, which is used to stimulate the growth of white blood cells in the bone marrow that helps fight infection after chemotherapy.
Although the regulator has issued GMP (GMP) compliance certificates for both Biocon drug manufacturing units, it made some observations on the drug product website.