Polpharma Biologics Group Announces That Its Joint Venture Bioeq Has Submitted a Biologics License Application (BLA) for Biosimilar Ranibizumab to the U.S. Food and Drug Administration (FDA)
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.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210806005187/en/
Contact information
Joseph Reeds
Head of Marketing, Polpharma Biologics
Joseph.reeds@polpharmabiologics.com
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
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
KAYTUS Completes 100-Cabinet Liquid-Cooled Data Center in Europe in Four Months6.1.2026 10:02:00 EET | Press release
KAYTUS announced that it has accelerated the deployment of large-scale liquid-cooled AI data centers through its integrated turnkey service. By combining deployment and commissioning, KAYTUS delivers a one-stop, end-to-end service, from installation to optimization and launch. Recently, KAYTUS completed the delivery of a 100-cabinet, high-density liquid-cooled AI data center in Europe in just four months, up to 80% faster than traditional deployment models. Through professional performance testing and tuning, overall system performance was improved by 20%, enabling a stable, high-efficiency business launch through on-site optimization and customization. This accelerated and resilient delivery addresses urgent AI infrastructure timelines and provides a scalable blueprint for deploying high-density liquid-cooled clusters across Europe. The customer is a European infrastructure unicorn delivering compute, storage, and networking services to the e-commerce, fintech, and digital media secto
Kashiv BioSciences to Present at the 44 th Annual J.P. Morgan Healthcare Conference6.1.2026 10:00:00 EET | Press release
Kashiv BioSciences, LLC (“Kashiv”), a vertically integrated biopharmaceutical company, today announced that Dr. Sandeep Athalye, Global Chief Executive Officer, and Dr. Paras Vasanani, Head of Business Development, will present at the 44th Annual J.P. Morgan Healthcare Conference in San Francisco, California, on Wednesday, January 14, 2026, at 11:00 a.m. PST. 44th Annual J.P. Morgan Healthcare Conference – Kashiv BioSciences Company Presentation Date: Wednesday, January 14, 2026 Time: 11:00 - 11:25 a.m. PST Location: Golden Gate Conference Room – The Westin St. Francis Hotel, San Francisco, California About Kashiv BioSciences: Kashiv BioSciences, LLC is a vertically integrated biopharmaceutical company with numerous commercial and advanced clinical-stage assets and is among the few U.S.-based companies to both manufacture and receive marketing authorization for multiple biosimilars. Kashiv BioSciences, LLC in the USA, and its subsidiaries in India (together “Kashiv BioSciences”) operat
CES 2026: GIGABYTE is “AI Forward,” Showcasing AI Factory, Physical AI, and Agentic AI Solutions6.1.2026 02:00:00 EET | Press release
GIGABYTE Technology, a global leader known for its engineering excellence in high-performance computing and AI servers, continues to strengthen its position as one of Taiwan’s most AI-centric server innovators. At CES 2026, GIGABYTE is to present its complete computing ecosystem under the theme “AI Forward”—highlighting how its technologies form the computational backbone of next-generation AI infrastructure, supporting AI development across cloud, edge, and personal devices, and full-stack solutions enabling organizations to deploy AI with greater speed, scale, and efficiency. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251224890815/en/ CES 2026: GIGABYTE is “AI Forward,” Showcasing AI Factory, Physical AI, and Agentic AI Solutions Build Future-Ready AI Factory GIGABYTE introduces its one-stop AI data center solution with GIGAPOD, a modular “Building-Block Design” that integrates high-performance servers, high-speed netw
Cooler Master Launches the MasterFrame 360 Series With Panorama, Stage Mirror and Stage LCD Versions5.1.2026 19:41:00 EET | Press release
Cooler Master, a global leader in PC components and tech lifestyle solutions, today announced the launch of the MasterFrame 360 Series. This new family of PC cases is designed for creators and enthusiasts who want a powerful PC build and a platform to express their personal style and be their “Showcase Without Limits.” With advanced cooling capacity and a 360-degree display stage, the series offers a blend of performance and presentation. Across the series, the MasterFrame 360 platform gives builders space for up to twelve 120 mm fans or a mix of 120, 140, and 200 mm options. Support for radiators up to 360 mm, plus clearance for flagship GPUs and PSUs, ensures great cooling no matter what you are doing. With compatibility for Mini-ITX, Micro-ATX, ATX, and BTF (back-connect) motherboards, every build remains clean, optimized, and future-ready. “Our community builds PCs that reflect who they are,” said Matteo Stracciari, General Manager of Cooler Master. “The MasterFrame 360 series give
Cooler Master Introduces COSMOS Alpha5.1.2026 19:38:00 EET | Press release
Cooler Master, a global leader in PC components and tech lifestyle solutions, today announced COSMOS Alpha, the next evolution of its iconic COSMOS series. The COSMOS Alpha reflects Cooler Master’s commitment to FreeForm 2.0 with its modular, open, and customizable technology. It gives boundary-pushing PC builders the freedom to shape the form and performance of their system. “COSMOS has always represented the height of craftsmanship and customization,” said Matteo Stracciari, General Manager of Cooler Master. “COSMOS Alpha carries that legacy forward in a flagship platform where every detail can be adjusted, optimized, or reimagined to match a builder’s vision.” A Signature Flagship Design COSMOS Alpha preserves the series’ premium modular design with distinctive curved aluminum frames and tempered glass side panels. Under-case ARGB lighting adds a refined visual accent that complements performance builds and showcase systems. Key Features for PC Builders Modular Sliding Tray System:
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