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
The LYCRA Company Launches LYCRA ® ADAPTIV fiber for Nonwovens, Advancing Comfort and Fit in Disposable Hygiene at INDEX™ 2613.5.2026 15:00:00 EEST | Press release
The LYCRA Company, a leader in innovative and sustainable fibers for apparel and personal care, today announced the official global launch of LYCRA® ADAPTIV fiber for nonwovens at INDEX™ 26, in Geneva, Switzerland, May 19–22. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260514856391/en/ At INDEX™ 26 in Geneva, The LYCRA Company debuts LYCRA® ADAPTIV fiber for nonwovens, a next-generation stretch solution that delivers enhanced comfort, a secure fit, and helps enable inclusive sizing for baby diapers, adult incontinence, and feminine care products. This breakthrough stretch fiber, already trusted by leading global apparel brands, now ushers in a new era of comfort, fit, and performance for baby diapers, disposable hygiene products, adult incontinence, and feminine care. LYCRA® ADAPTIV fiber is engineered to address key unmet needs in hygiene and personal care. According to the company’s proprietary research, these include f
Adtran expands SDG 8700 Series to deliver Wi-Fi 7 at scale13.5.2026 15:00:00 EEST | Press release
Adtran today announced an expansion of its SDG 8700 Series, extending Wi-Fi 7 across a broader range of residential service tiers and deployment models. The expanded portfolio introduces new 2.5Gbit/s and 10Gbit/s Wi-Fi 7 platforms designed to support the full spectrum of multigigabit services – from entry-level offerings to premium tiers – across residential, SMB, MDU and community Wi-Fi deployments. As service providers enter a new access refresh cycle, Wi-Fi 7 is rapidly becoming a baseline requirement rather than a premium differentiator. Adtran’s expanded SDG 8700 portfolio enables providers to deploy next-generation Wi-Fi more broadly and consistently without compromising subscriber experience or changing operational models. The launch also builds on the FCC’s recent conditional approval of Adtran’s SDG portfolio, supporting continued broadband rollout momentum. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/202605130036
Austrian Broadband Operator Deploys Vecima’s Entra ® vCMTS and Remote PHY Devices to Advance its Next-Generation DOCSIS ® Network13.5.2026 14:45:00 EEST | Press release
Vecima Networks Inc. (TSX: VCM) and Witke today announced that an Austrian broadband operator is deploying the Entra® virtualized Cable Modem Termination System (vCMTS) as the DOCSIS® platform for its Distributed Access Architecture (DAA) evolution. The deployment, led by Witke, enables advanced reliability, scalable capacity expansion over time, and a clear migration path toward DOCSIS 4.0 broadband services. After extensive system planning and evaluation, the operator selected a vCMTS and Remote PHY (R-PHY) architecture to align with its long-term network roll-out strategy and migration requirements. The deployment provides the flexibility to modernize the network in phases while reducing space, power, and cooling requirements across the operator’s infrastructure. Entra vCMTS establishes a new standard for simplified, virtualized Cable Access, combining a modern microservices architecture with commercial off-the-shelf (COTS) hardware to deliver next-generation flexibility while enhan
Vecima, Incognito, and BM COM Announce Turnkey Fiber Broadband Solutions at ANGA COM 202613.5.2026 14:30:00 EEST | Press release
Vecima Networks Inc., Incognito Software Systems Inc., and BM COM s.r.o., today announced a strategic collaboration to deliver a fully integrated, turnkey fiber broadband solution, which will be showcased at ANGA COM 2026, May 19–21 in Cologne, Germany. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260513492655/en/ The joint solution brings together best-in-class fiber access infrastructure, advanced service orchestration, and in-market deployment expertise into a unified, interoperable Broadband-in-a-Box platform without requiring single vendor lock-in. Designed to simplify and accelerate fiber broadband rollouts, the solution enables operators—particularly regional and emerging providers—to deploy scalable, high-performance networks with reduced complexity and faster time to revenue. The joint Vecima, Incognito, and BM COM Broadband-in-a-Box solution integrates: Vecima’s Entra® XGS-PON platform, delivering scalable, high-
Veristat Launches AI Biostatistics Platform, Cutting Clinical Trial Data Readout Time from 5 Weeks to 5 Days * Without Regulatory Risks13.5.2026 14:05:00 EEST | Press release
Veristat™, a global clinical research organization (CRO) and consultancy specializing in complex studies, announced the launch of InStat™ by Veristat. InStat is the clinical research industry’s first zero-code, fully automated biostatistics solution, reducing manual effort to speed time to approval with every output backed by validated statistical engines and expert biostatistician review. It delivers submission-ready tables, listings, and figures (TLF) in five days or less*, rather than the four to six weeks sponsors typically wait after database lock, while maintaining the highest quality data. Veristat will begin using InStat to deliver biostatistics services in June. Clene Nanomedicine is the first clinical trial sponsor whose work was delivered using InStat, with NfL biomarker analyses supporting their planned 2026 New Drug Application (NDA). "Following recent FDA interactions, we are advancing our NDA submission for CNM-Au8 with NfL biomarker concordance evidence as a core compon
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