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)
6.8.2021 12:13:00 EEST | Business Wire | Press release
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
TetraMem Announces 22nm Multi-Level RRAM Analog In-Memory Computing SoC Milestone16.5.2026 11:43:00 EEST | Press release
TetraMem Inc., a Silicon Valley–based semiconductor company developing analog in-memory computing (IMC) solutions, today announced the successful tape-out, manufacturing, and initial silicon validation of its MLX200 platform, a 22nm multi-level RRAM-based analog IMC system-on-chip (SoC). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260516556464/en/ Photograph of the MLX200 chip with a five-cent coin for size reference The achievement marks a significant step toward the commercialization of analog computing architectures based on emerging non-volatile memory technologies, addressing the growing challenges of data movement, power consumption, and thermal constraints in modern AI systems. As AI workloads continue to scale, system performance is increasingly constrained by the cost of moving data between memory and compute units. Analog in-memory computing offers a fundamentally different approach by performing computation dir
NTT DATA Announces Intent to Acquire WinWire to Scale Enterprise AI Adoption and Accelerate Industry Transformation with Microsoft15.5.2026 19:36:00 EEST | Press release
NTT DATA, a global leader in AI, digital business and IT services, today announced it has signed a definitive agreement to acquire WinWire,an award-winning Microsoft partner specializing in Agentic AI, AI on Azure, data engineering and cloud-native development as foundational capabilities for enterprise AI. The acquisition strengthens NTT DATA’s position as a trusted partner to help organizations move beyond experimentation to operationalize AI at scale. The acquisition further advances NTT DATA’s enterprise AI strategy as demand accelerates for AI-driven, cloud-native transformation. By expanding capabilities across data platforms, agentic AI and modern applications, NTT DATA is sharpening its ability to deliver production-ready AI solutions aligned to industry needs, reinforcing its leadership as Microsoft’s Global System Integrator (GSI) Growth Champion Partner of the Year. Upon closing, WinWire will add more than 1,000 skilled Azure engineers and Microsoft specialists to NTT DATA,
STARTEEPO Invest Announces 5% Stake in Xerox Holdings Corporation15.5.2026 19:15:00 EEST | Press release
STARTEEPO Invest (“STARTEEPO”), an alternative investment fund focused on public equity opportunities, today announced that it has acquired a significant ownership position in Xerox Holdings Corporation (“Xerox” or the “Company”). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260515594020/en/ As of the date of this release, STARTEEPO and its affiliates beneficially owns 6.6 million shares of Xerox (excluding options), representing approximately 5.05% of the Company’s outstanding common stock. STARTEEPO has filed a Schedule 13D with the U.S. Securities and Exchange Commission (the “SEC”) providing additional details regarding its investment. Investment Perspective STARTEEPO believes that Xerox represents an interesting investment opportunity supported by a combination of balance sheet initiatives, ongoing operational improvements, and its position within a changing and consolidating industry. In STARTEEPO’s view, the Company
NTT DATA Announces Intent to Acquire WinWire to Scale Enterprise AI Adoption and Accelerate Industry Transformation with Microsoft15.5.2026 17:00:00 EEST | Press release
NTT DATA, a global leader in AI, digital business and IT services, today announced it has signed a definitive agreement to acquire WinWire,an award-winning Microsoft partner specializing in Agentic AI, AI on Azure, data engineering and cloud-native development as foundational capabilities for enterprise AI. The acquisition strengthens NTT DATA’s position as a trusted partner to help organizations move beyond experimentation to operationalize AI at scale. The acquisition further advances NTT DATA’s enterprise AI strategy as demand accelerates for AI-driven, cloud-native transformation. By expanding capabilities across data platforms, agentic AI and modern applications, NTT DATA is sharpening its ability to deliver production-ready AI solutions aligned to industry needs, reinforcing its leadership as Microsoft’s Global System Integrator (GSI) Growth Champion Partner of the Year. Upon closing, WinWire will add more than 1,000 skilled Azure engineers and Microsoft specialists to NTT DATA,
Experian Expands Agent Trust Partner Ecosystem with Akamai to Advance Trusted AI Driven Commerce15.5.2026 16:00:00 EEST | Press release
Experian today announced that Akamai Technologies has joined its growing partner ecosystem, designed to further advance secure, trusted AI driven commerce through the Experian Agent Trust™ framework, alongside partner Skyfire supporting emerging payment innovation. As AI agents begin to search, decide, and transact autonomously, they introduce a fundamental challenge for businesses: how to trust an action when it is no longer directly initiated by a human. Without a verified connection between humans and AI agents, autonomous commerce introduces new risks in fraud, misrepresentation, and unauthorized transactions. Experian Agent Trust is designed to address this challenge by establishing identity, accountability, and trust in agent driven interactions. “Trust, security, and performance must scale alongside the growing role of AI agents in digital commerce,” said Kathleen Peters, Chief Innovation Officer at Experian. “Agentic commerce will not scale without trust. By adding Akamai to ou
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