Biotechnology firm Biocon said its subsidiary has received approval from the US health regulator to market a generic medication to treat chronic heart failure. Biocon Pharma has received approval of its ANDA for Sacubitril/Valsartan Tablets, in 24 mg/26 mg, 49 mg/51 mg and 97 mg/103 mg strengths, from the US Food and Drug Administration (USFDA), the company said in a regulatory filing. Sacubitril and valsartan combination is used to treat chronic heart failure in adults to help reduce the risk of death and hospitalisation. The medicine is also used to treat paediatric patients over the age of one year. The approval further adds to Biocon's portfolio of vertically integrated, complex drug products, the company said.
Agreement clears way for Indian company to launch treatment in Europe, Canada and other markets
Biocon Biologics on Thursday said it has inked a pact with Janssen for launching a biosimilar medication for the treatment of autoimmune diseases in Europe, the United Kingdom, Canada, and Japan. The company, a subsidiary of Biocon Ltd, has inked a settlement and licence agreement with Janssen Biotech Inc, Janssen Sciences Ireland, and Johnson & Johnson. This agreement clears the way to commercialise its Bmab 1200, a proposed biosimilar to Stelara. As per the terms of the settlement agreement, Biocon Biologics has resolved patent disputes with Janssen to secure market entry dates in Europe, the UK, Canada, and Japan, the company said in a statement. Regulatory filings in these markets are currently under review, it added. Biocon Biologics had earlier announced a settlement agreement in the US for Bmab 1200 launch no later than February 22, 2025, once approved by the USFDA. The US health regulator has accepted the company's Biologics License Application (BLA) for Bmab 1200 for ...
Kiran outlines how being vertically integrated puts Biocon in a strong position
Bevacizumab is used to treat colon and rectal cancer, cervical cancer etc
Biocon's generics would join at least 15 other generics or biosimilars in development by Chinese drugmakers ahead of an expiry of patent protection on semaglutide
Bengaluru-based company announces 'strategic partnership' with Handok
European markets closed on a negative note, with Germany's DAX falling 0.22 per cent and the UK's FTSE dropping 0.09 per cent
Peter Bains discusses their efforts to gain market share in key regions, the impact of lower active pharmaceutical ingredient prices, and growth plans for biosimilars and generics
Company says approval is a 'significant milestone' and marks entry in new therapeutic area in the US
Biocon has re-appointed Kiran Mazumdar Shaw as an Executive Director of the company for a further period of 5 years starting April 2025
Biocon Q4FY24 results: The company board has recommended a final dividend at the rate of 10 per cent i.e. Re. 0.50 per equity share
Q4 FY24 company results: Dixon Technologies, Jindal Stainless, Power Finance Corporation, Thomas Cook will also release their financial results
Nifty50 outlook: On the downside, the 21,850-22,150 zone is anticipated to provide support. Traders are advised to maintain caution
Syngene International shares ended the day's trade on BSE at Rs 694.2 apiece, down one per cent
Biomm SA develops and commercialises complex biotech and biosimilar drug products
Biotechnology firm Biocon on Wednesday said it has tied up with Brazil-based Biomm SA for the commercialisation of its diabetes drug in the Latin American nation. Under the terms of the agreement, Biocon will undertake the development, manufacturing and supply of Semaglutide (gOzempic), and Biomm will be responsible for obtaining regulatory approval and commercialization in the Brazilian market. Biomm focuses on developing, manufacturing and commercialising complex biotech and biosimilar drug products at its production facility in Nova Lima. "Our partnership with Biomm marks another important step forward in our strategy to expand our global footprint beyond the US and Europe for Peptides," Biocon CEO and MD Siddharth Mittal said in a statement. This is also in line with the growth strategy of bringing to market a portfolio of complex, GLP-1 drug-device combination products, he added. "We are confident that our collaboration with Biomm will provide patients in Brazil, who are livi
The company, helmed by Kiran Mazumdar Shaw, is leading the charge among Indian drugmakers - the world's largest supplier of generic medicines - as they race to grab a slice of the obesity drugs market
Stocks to watch on March 28: Adani Power has awarded a contract valued at Rs 4,000 crore to Bharat Heavy Electricals for the establishment of a thermal power plant in Chhattisgarh
Shares of Biocon slipped 5 per cent to Rs 254.15 on the BSE in Friday's intra-day trade as the company's unit Biocon Biologics will sell its Indian branded formulations businesses to Eris Lifesciences