Insulin aspart biosimilar(Biocon Ltd.)

BENGALURU, India, Nov. 30, 2023 /PRNewswire/ -- Biocon Biologics Ltd (BBL), a subsidiary of Biocon Ltd (BSE code: 532523, NSE: BIOCON), today announced that the integration of the Viatris' biosimilars business in 31 European countries has been successfully completed. Following the acquisition of substantially all of the global biosimilar business of Viatris in November 2022, and the related integration of over 70 emerging market countries in July 2023 and North America in September 2023, the full transition of Viatris' biosimilars operations to Biocon Biologics Ltd in Europe represents another significant milestone as a world-leading biosimilars company. In Europe, Biocon Biologics portfolio includes 7 biosimilars: Insulin Aspart and Insulin Glargine, Bevacizumab, Pegfilgrastim, Trastuzumab, Adalimumab, and Etanercept. At a global level, Biocon Biologics has a robust pipeline of 20 assets for diabetology, oncology, immunology, ophthalmology, and bone health. Serving over 5.7M patients annually, the Company is committed to providing access to high-quality therapies and solutions to patients, healthcare systems and governments across the globe. Shreehas Tambe, CEO & Managing Director, Biocon Biologics Ltd, said: "The integration of the Viatris' biosimilar business in Europe ahead of schedule is another important milestone for Biocon Biologics in our journey as a global biosimilars leader. We are pleased to expand access to life-saving treatments for patients across Europe. Our unique, fully integrated capabilities and robust pipeline of 20 products will allows us to better address patient needs and be a reliable partner to health organisations. " Jozef Belcik, Head of Commercial Europe & JANZ, Biocon Biologics Ltd, said: "We are extremely pleased to have reached this historic moment and we are proud to lead the way in the advancement of biosimilars. As we continue to drive innovation and invest in the future, our mission is singularly focused on the development, manufacturing, distribution, and commercialization of biosimilars in Europe and in the world. " After the acquisition from Viatris, Biocon Biologics and its partners will commercialize biosimilar products in the following countries: Albania, Austria, Belgium, Bosnia, Bulgaria, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, and The United Kingdom. Note about biosimilars: Based on IQVIA White Paper "The impact of biosimilar competition in Europe, IQVIA (2022)", as of 2022, the cumulative savings at list prices from the impact of biosimilar competition in Europe reached over €30 billion. Furthermore, since the launch of biosimilars these provided nearly 4.5 billion patient treatment days to European patients. Source: 1-The impact of biosimilar competition in Europe, IQVIA (2022) December 2022. About Biocon Biologics Limited: Biocon Biologics Ltd. (BBL), a subsidiary of Biocon Ltd., is a unique, fully integrated, global biosimilars company committed to transforming healthcare and transforming lives by enabling affordable access to high quality biosimilars for millions of patients worldwide. It is leveraging cutting-edge science, innovative tech platforms, global scale manufacturing capabilities and world-class quality systems to lower costs of biological therapeutics while improving healthcare outcomes. BBL has acquired substantially all of the global biosimilars business of its long-standing partner Viatris, which is a historic milestone in its value creation journey. Biocon Biologics has commercialized eight biosimilars in key emerging markets and advanced markets like U.S., Europe, Australia, Canada, and Japan. The Company has a pipeline of 20 biosimilar assets across diabetology, oncology, immunology, ophthalmology, and other non-communicable diseases. It has many 'firsts' to its credit in the biosimilars industry. As part of its environmental, social and governance (ESG) commitment, BBL is advancing the health of patients, people, and the planet to achieve key UN Sustainable Development Goals (SDGs). Website: ; Follow us on LinkedIn: Biocon Biologics ; Twitter: @BioconBiologics for company updates. Biocon Limited, publicly listed in 2004, (BSE code: 532523, NSE Id: BIOCON, ISIN Id: INE376G01013) is an innovation-led global biopharmaceuticals company committed to enhance affordable access to complex therapies for chronic conditions like diabetes, cancer and autoimmune. It has developed and commercialized novel biologics, biosimilars, and complex small molecule APIs in India and several key global markets as well as Generic Formulations in the US, Europe & key emerging markets. It also has a pipeline of promising novel assets in immunotherapy under development. Website: ; Follow-us on Linked In: Biocon Limited; Twitter: @bioconlimited for company updates. Forward -Looking Statements: Biocon This press release may include statements of future expectations and other forward-looking statements based on management's current expectations and beliefs concerning future developments and their potential effects upon Biocon and its subsidiaries/ associates. These forward-looking statements involve known or unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. Important factors that could cause actual results to differ materially from our expectations include, amongst other: general economic and business conditions in India and overseas, our ability to successfully implement our strategy, our research and development efforts, our growth and expansion plans and technological changes, changes in the value of the Rupee and other currency changes, changes in the Indian and international interest rates, change in laws and regulations that apply to the Indian and global biotechnology and pharmaceuticals industries, increasing competition in and the conditions of the Indian and global biotechnology and pharmaceuticals industries, changes in political conditions in India and changes in the foreign exchange control regulations in India. Neither Biocon, nor our Directors, or any of our subsidiaries/associates assume any obligation to update any particular forward-looking statement contained in this release. SOURCE Biocon Biologics Ltd.

GSK's partnership with Zhifei, BioNTech's HER3 ADC deal and the FDA's rejection of Biocon's insulin aspart biosimilar made our news this week. GSK has tapped Chongqing Zhifei to distribute Shingrix in China. BioNTech in-licensed a HER3 antibody-drug conjugate from Chinese company MediLink Therapeutics. Manufacturing shortfalls have derailed Biocon's FDA application for a proposed biosimilar to Novo Nordisk's NovoLog. And more. 1. GSK strikes $3B Shingrix partnership with China powerhouse Zhifei. Is a deal for an RSV shot next? GSK has signed on Chongqing Zhifei Biological Products to distribute its shingles vaccine, Shingrix, in China. Zhifei will buy around $3 billion worth of the vaccine to sell in China from 2024 through 2026, and the partnership could be extended. The two companies could expand the deal to include GSK’s RSV shot in the future. Zhifei made a name for itself by propelling the growth of Merck’s Gardasil franchise in China. 2. BioNTech takes another leaf out of Daiichi playbook, paying $70M for HER3-directed ADC BioNTech has inked another partnership with a Chinese biotech. This time, the German company has paid $70 million upfront to MediLink Therapeutics for an HER3-directed antibody-drug conjugate, a potential competitor to Daiichi Sankyo’s patritumab deruxtecan. The deal value could grow to more than $1 billion if all milestones are met. BioNTech has recently teamed with several Chinese companies, including Duality Biologics and Biotheus. 3. FDA hits Biocon's insulin copycat with a CRL as plant awaits pre-approval inspection The FDA has rejected Biocon’s biosimilar version of Novo Nordisk’s NovoLog, or insulin aspart, again. Back in early 2022, the FDA issued a complete response letter for the drug’s application. This time, the rejection is related to observations from an August 2022 inspection that resulted in a Form 483 for Biocon’s Malaysia facility. The FDA didn’t perform a reinspection in time before the regulatory decision date.   4. Sanofi pays $10M upfront in hope 'biological map of proteins' leads to drug discovery treasure In a deal potentially worth more than $1 billion, Sanofi has tapped Sino-American company BioMap’s artificial-intelligence-based protein map. The technology aims to guide how protein therapies may be applied in different disease areas. Sanofi has recently laid out a plan to become “the first pharma company powered by artificial intelligence at scale.” 5. Fujifilm Irvine Scientific, Formulated Solutions each lay off 50-plus staffers, filings show Fujifilm Irvine Scientific recently laid off 57 workers in California. The company offers cell culture solutions and medical devices for researchers in cell therapy and regenerative medicine. It opened a new manufacturing facility in the Netherlands in late 2021 alongside its campuses in California and Tokyo. Other News of Note: 6. Astellas starts Veozah TV push, pitching menopause drug as how to go from hot flashes to not flashes 7. Korean CDMO Lotte Biologics buys land, sets out to build 3 new plants by 2030