POLPHARMA-BIOLOGICS
Polpharma Biologics Group announces that its joint venture company with Santo Holding (Strüngmann Group), Bioeq, has submitted a biologics license application (BLA) to the U.S. Food and Drug Administration (FDA) for their biosimilar candidate of the ophthalmological drug Ranibizumab (Lucentis® ).
The reference product is a monoclonal anti-angiogenic antibody fragment (Fab) used to treat various types of macular-degenerative diseases such as neovascular (wet) age-related macular degeneration, diabetic retinopathy, macular edemas and myopic choroidal neovascularization. Worldwide, at least 25 to 30 million people are affected by age-related macular degeneration. The launch of a biosimilar Ranibizumab can increase market competition, reduce cost and expand patient access with proven analytical and clinical similarity to the original product. It works by inhibiting vascular endothelial growth factor (VEGF), which is responsible for the excessive formation of blood vessels in the retina.
Subject to FDA's approval of this BLA, the product will be exclusively commercialized by Coherus BioSciences, Inc. in the United States.
Said submission represents the most recent milestone for Bioeq's ranibizumab biosimilar program and compliments marketing authorization applications submitted to EMA and UK MHRA already in July this year.
Dr Joerg Windisch, CEO of the Polpharma Biologics Group, commented:
“The submission of a BLA to the FDA is a major milestone for any therapeutic and brings hope to patients across the US. This announcement carries a tangible promise of treatment choice and improved access to those who suffer from debilitating vision loss, including age-related macular degeneration. This is another representation of our commitment to providing safe and effective medicines to patients.”
1) Lucentis ® is a registered trademark of Genentech Inc.
About Ranibizumab biosimilar
The Ranibizumab biosimilar, previously designated as FYB201 (and also known as CHS-201), has been originally licensed from Formycon AG (FRA: FYB/ WKN A1EWVY), a leading German biosimilars company, and subsequently developed by Bioeq AG, a joint venture between Polpharma Biologics and Santo Holding AG (Strüngmann Group). Phase III clinical trials for FYB201 have clinically demonstrated that the efficacy of FYB201 in patients with nAMD is comparable to that of Lucentis® .
About biosimilars
Biosimilars are intended for use in place of existing, branded biologics to treat a range of chronic and often life-threatening diseases, with the potential to reduce costs and expand patient access. Biosimilars exhibit proven analytical and clinical similarity to their respective branded reference products.
About Polpharma Biologics Group
The Polpharma Biologics Group creates quality biosimilars with a passion to improve lives of patients. The group has built an extensive and growing pipeline of biosimilars to treat a number of medical conditions across major therapeutic areas. Several of these biosimilar assets have already been commercially partnered with the world’s largest biopharmaceutical companies.
The group operates a network of state-of-the-art development and manufacturing facilities across Europe, actively investing in technology, people and know-how, employing over 800 specialists from around the globe.
Learn more at www.polpharmabiologics.com
About Bioeq
Bioeq is a Swiss biopharmaceutical joint venture between the Polpharma Biologics Group and the Strüngmann Group. Bioeq develops, licenses and commercializes biosimilars.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210806005187/en/
Link:
Social Media:
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Andersen Global styrker sine vurderingskapaciteter i Asien og Stillehavsområdet med ETC11.12.2025 12:29:00 CET | Pressemeddelelse
Andersen Global fortsætter med at udvide sin tilstedeværelse i Asien og Stillehavsområdet gennem en samarbejdsaftale med Edmund Tie & Company (ETC), et full-service ejendomsrådgivningsfirma med hovedsæde i Singapore. ETC blev stiftet i 1995 og leverer vurderings- og rådgivningsydelser på tværs af ejendommens livscyklus, herunder lovpligtig og selskabsrelateret vurdering, investeringsrådgivning, feasibility-analyser og rådgivning om ejendomsskat. Med aktiviteter i Singapore, Malaysia og Thailand kombinerer ETC dybdegående regional viden med internationale standarder for at støtte udviklere, investorer, private og statslige fonde, selskaber, REIT'er samt ejere og lejere. Firmaet er kendt for sin forskningsbaserede tilgang og integrerede servicemodel og hjælper kunder med at navigere i komplekse lovgivninger og optimere værdien af deres aktiver. "Vores styrke ligger ikke kun i den tekniske udførelse, men i at hjælpe kunder med at se det fulde billede – at forbinde markedssignaler, lovgivn
AB InBev and International Cricket Council Announce Landmark Global Partnership11.12.2025 10:31:00 CET | Press release
World’s Leading Brewer becomes the Official Beer Partner of the ICC The International Cricket Council (ICC) announced AB InBev (Euronext: ABI) (NYSE: BUD) (MEXBOL: ANB) (JSE: ANH), the world’s leading brewer, will become the Official Beer Partner for all major ICC tournaments starting in 2026. The partnership will be led by Budweiser 0.0, Budweiser’s no-alcohol beer in India, with other ABI mega brands activating in Europe and Africa. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251211250826/en/ AB InBev and ICC announce global partnership From attending a match live in-stadium to watching one at a bar or pub with friends, with a lower alcohol-by-volume (ABV) and no-alcohol options like Budweiser 0.0, beer is the natural choice to enjoy responsibly. Through this partnership with the ICC, AB InBev will create more moments of cheers, choice and celebration for cricket fans of legal drinking age all over the world. ICC CEO, S
Spark Reply and Concept Reply Promote CO₂-optimised Charging Together With BMW11.12.2025 10:30:00 CET | Press release
Spark Reply, specialists in design and user experience, and Concept Reply, IoT and AI technology experts within the Reply Group, have developed a smart app for the BMW group as part of a research project that actively encourages electric vehicle drivers to adopt low-carbon charging habits. The “COOL” feature within the BMW Prototyping App “360° Mobility” analyses the current electricity mix and shows users in real time when it is at its cleanest. Playful interactions and personalised AI-generated images further motivate drivers to make more sustainable choices. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251211155452/en/ In a post pilot survey, 73 per cent of participants stated that they were willing to make an extra effort to charge with reduced CO₂ emissions, such as by setting a charging window in their app. This proves that 'COOL' can measurably reduce the carbon footprint of everyday electric driving. Electric mobil
Thales Launches AI Security Fabric, Providing AI Runtime Security for Agentic AI and LLM-Powered Applications11.12.2025 09:00:00 CET | Press release
Thales launches its new AI Security Fabric, delivering the first runtime security capabilities designed to protect Agentic AI, LLM-powered applications, enterprise data, and identities.New capabilities address emerging AI-specific threats—including prompt injection, data leakage, model manipulation, and insecure RAG pipelines—helping organizations innovate safely while maintaining compliance.With upcoming 2026 enhancements, Thales aims to provide a comprehensive security layer for AI ecosystems, enabling enterprises to confidently scale AI adoption across cloud and on-premises environments. AI is one of the fastest-growing technologies in the history of modern business, with the ability to revolutionize industries, optimize operations, and drive innovation, but it is also introducing security gaps, risks, and vulnerabilities. According to McKinsey, 78% of organizations are using AI in at least one business function, up from 55% two years ago. As a result, 73% of them are investing in A
Interactive Brokers Adds Access to Brazil’s B3 Exchange11.12.2025 09:00:00 CET | Press release
Interactive Brokers (Nasdaq: IBKR), an automated global electronic broker, today announced that eligible clients outside of Brazil can now trade Brazilian equities through B3, the Brazil Stock Exchange. This expansion gives investors more ways to access emerging market opportunities across Latin America alongside global stocks, options, futures, currencies, bonds, funds, and more through a single unified platform. The B3 Exchange is one of the most active and liquid markets in the region. With this addition, investors will have direct access to trade Brazilian equities, plus over 160 markets worldwide using Interactive Brokers’ powerful trading platforms and tools. “Global investors need seamless access to diverse markets to stay competitive,” said Milan Galik, Chief Executive Officer of Interactive Brokers. “By adding Brazil’s B3 Exchange, we’re giving our clients efficient, low-cost access to one of the world’s most dynamic emerging economies through our unified global platform.” Int
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom