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
Ohmium Breaks Barriers: Exceeds 2030 Industry Targets of 10 GW/ton to Achieve 18 GW/ton Iridium Utilization13.11.2025 10:05:00 EET | Press release
Ohmium International Inc., a leading provider of cutting-edge, high-efficiency, and modular Proton Exchange Membrane (PEM) electrolyzers, has surpassed the PEM electrolyzer industry's 2030 target of 10 GW per ton to attain an 18 GW per ton iridium utilization rate. Ohmium has made significant technological advancements which have resulted in reducing its iridium usage by 50% in its Lotus electrolyzer, Mark 2. This enhances the cost-competitiveness of green hydrogen production by reducing the overall cost of its PEM electrolyzers, which have been impacted by the cost of the precious metal, iridium. Dr. Chock Karuppaiah, Ohmium Chief Science and Technology Officer, said, "We've made significant strides in reducing iridium usage in our PEM electrolyzers, exceeding the 2030 industry target of 10 GW per ton. We've achieved a utilization rate of 18 GW per ton. This innovation is crucial, as iridium is one of the most expensive materials in electrolyzer manufacturing.” Dr. Markus Tacke, Ohmiu
Europe Must Embrace Long Duration Energy Storage to Manage Costs and Meet Climate Goals: New Report13.11.2025 10:01:00 EET | Press release
Policies to incentivize investment in longer duration energy storage can mitigate billions in grid costs, while helping the continent hit its 2050 climate goals and achieve energy independence, according to a new whitepaper from Hydrostor. The paper explores how, through policies aimed at increasing strategic investment in long duration energy storage (LDES), EU member states could cut grid expansion and curtailment costs by 2040, while avoiding spending billions on stranded natural gas assets1. Deploying these technologies across Europe can save €103 billion by 2040, according to recent research from Energy Storage Europe Association. Doing so in the UK could save €35 billion by 2050, according to LCP Delta analysis on behalf of the UK government.2 Hydrostor President, Jon Norman, said: “As global momentum grows behind long-duration energy storage, Europe risks being left behind. States must act now to deliver projects in time to fulfill their international commitments and ambitions.
Virometix AG Announces Completion of $15 Million Financing Round to Advance Development of V-212 and Next-Generation Synthetic Vaccines13.11.2025 08:00:00 EET | Press release
Virometix AG, a clinical-stage biotechnology company pioneering fully synthetic vaccines, today announced the completion of a $15 million financing round from existing shareholders. The funds will support continued clinical and development activities for V-212, Virometix’s lead serotype-independent pneumococcal vaccine candidate, currently in Phase I clinical evaluation. Proceeds from the financing will be used to: Advance the ongoing Phase I clinical trial of V-212, with topline results expected in Q1 2026. Prepare for a planned Phase Ib combination trial evaluating V-212 with an approved pneumococcal conjugate vaccine (PCV). Complete OPK assay validation to support immunogenicity and functional data read-outs. Implement platform enhancements to the company’s proprietary Synthetic Virus-Like Particle (SVLP) technology. Progress next-generation serotype-independent pneumococcal vaccine programs toward preclinical development. “This financing demonstrates the continued confidence and co
IMEC Achieves a World-record GaN Breakdown Voltage Exceeding 650 V on Shin-Etsu Chemical’s 300-mm QST™ Substrate13.11.2025 06:00:00 EET | Press release
The QSTTM substrate*1, a 300-mm GaN growth substrate that Shin-Etsu Chemical Co., Ltd. (Head Office: Tokyo; President: Yasuhiko Saitoh; hereinafter, “Shin-Etsu Chemical”) developed, has been adopted for the 300-mm GaN power device development program at IMEC*2, where sample evaluation is in progress. In the evaluation, the 5 µm-thick HEMT*3 device using a QSTTM substrate achieved a record-breaking voltage resistance exceeding 650 V for a 300mm substrate. Shin-Etsu Chemical, licensed by QROMIS, Inc. (Head office: CA, U.S.A, CEO: Cem Basceri, hereafter "QROMIS"), manufactures 150-mm and 200-mm QST™ substrates, as well as GaN-on-QST™ epitaxial substrates of various diameters. In September 2024, we started providing 300-mm QST™ samples in a joint initiative with QROMIS. Furthermore, Shin-Etsu Chemical and QROMIS have established a close partnership to provide 300-mm QST™ substrates for the state-of-the-art 300-mm CMOS fab of IMEC, which is based in Leuven, Belgium. IMEC is a 300-mm GaN pow
DBS and Ant International Enhance Strategic Partnership to Scale Innovative Cross-Border Payment and Fintech Solutions to Drive Inclusive Growth13.11.2025 05:00:00 EET | Press release
DBS and Ant International have agreed to deepen their existing strategic collaboration to jointly explore innovative payments, digitisation and fintech solutions aimed at providing more inclusive services for regional businesses of all sizes and individual consumers. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251112714266/en/ From left to right: Tan Su Shan, CEO of DBS, Loy Hwee Chuan, Segment Head of Telecommunications, Media & Tech, Hong Kong and GBA, DBS, Edward Yue, Alipay+ General Manager for SEA, ANZ and South Asia at Ant International, Peng Yang, CEO of Ant International The collaboration will leverage DBS’ digital banking capabilities and Ant International’s cutting-edge financial technologies such as AI and blockchain, to scale cross-border payments, strengthen connectivity and drive innovations in the financial ecosystem. The Memorandum of Understanding (MoU) was inked on the sidelines of the Singapore Fintech
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