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
Hologic Signs Definitive Agreement to Acquire Reveal Genomics19.10.2026 22:30:00 EEST | Press release
Hologic, a global leader in women’s health, today announced that it has signed a definitive agreement to acquire Reveal Genomics, a precision oncology company based in Barcelona, Spain, that develops advanced genomic diagnostic tests to help personalized cancer treatment, including its HER2DX test to help optimize therapy for patients with HER2-positive breast cancer. Breast cancer remains one of the most significant health challenges women face today. Reveal Genomics’ tests are highly complementary to Hologic’s existing oncology diagnostics, including the Breast Cancer Index® (BCI) test, the guideline-recognized genomic assay to help inform decisions regarding extended endocrine therapy in women with HR+ early-stage breast cancer. The combination of Hologic’s existing testing with Reveal Genomics’ portfolio represents a significant expansion of Hologic’s diagnostic oncology solutions, with the combined offering of new and existing testing expected to help inform treatment decisions fo
An Active Role in Freshness: ProAmpac Introduces ProActive Intelligence Shelf Protect19.10.2026 22:27:00 EEST | Press release
ProAmpac, a global leader in flexible packaging and material science, introduces ProActive Intelligence™ Shelf Protect (SP) Series, giving food producers a new way to help preserve product quality and reduce costly spoilage. Designed for select meat, seafood, and dairy applications, the technology is FDA- and USDA-compliant for intended uses in fresh beef, fresh pork, cooked sausage, deli meat, fresh salmon, and fresh cheese. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261019305953/en/ Clearshield®-SP Shrink Bag This direct food-contact biotechnology packaging helps reduce microbial growth associated with food spoilage in intended applications, supporting longer shelf life throughout storage and distribution. Shelf Protect’s patented biotechnology is built directly into food-contact packaging film. “For meat processors, every product lost represents an investment in production, packaging, and distribution that goes unreal
Vedanta Ltd Doubles Zinc Capacity in South Africa with US$ 600 Mn investment19.10.2026 20:19:00 EEST | Press release
Vedanta Limited doubled its annual zinc production capacity to 500,000 tonnes1in South Africa through an investment of nearly US$ 600 Mn at Gamsberg (Phase II) at Vedanta Zinc International (VZI). Gamsberg has one of the world’s most significant zinc deposits and is VZI’s flagship zinc mine. Inaugurated by South African President Cyril Ramaphosa and Vedanta Limited Director Priya Agarwal-Hebbar, this expansion marks one of the decade’s largest mining investments in South Africa. It advances Vedanta Limited’s position as the world’s largest2 zinc producer, with a vision of achieving 3 million tonnes of annual production across India and South Africa. Of this, 2 million tonnes are targeted from its subsidiary, Hindustan Zinc Limited the world’s largest integrated zinc producer, while Vedanta Zinc International business aims to contribute 1 million tonnes annually. This expansion strengthens the ZAR 21 Bn (nearly US$ 1.5 Bn) investment commitment Vedanta made at the 2018 South Africa Inve
Unlocking Digital Gold’s US$700bn Opportunity19.10.2026 19:00:00 EEST | Press release
The digital gold market, worth US$45–55bn today, could unlock up to US$700bn in latent demand, according to new research from World Gold Council and Boston Consulting Group. The report points to substantial untapped appetite among retail investors, with nearly nine in ten surveyed saying they would consider digital gold under the right conditions. The US$700bn opportunity represents the report’s estimate of total latent demand that could be released if today’s barriers to adoption were removed, rather than a near-term forecast. The report’s five-year base case sees digital gold growing by around 27% a year to US$160–170bn by 2031. That could rise to US$270–280bn over the same time if more barriers fall faster. Momentum is already building as financial markets undergo a broader digital transformation, bringing tokenised investment products increasingly into the mainstream. Tokenised gold, one segment of the digital gold market alongside vaulted digital gold, has grown fivefold in value
Roquette Brings Broad Portfolio of Excipient Solutions and Technical Expertise to AAPS PharmSci 360 202619.10.2026 17:00:00 EEST | Press release
Roquette, a global leader in plant-based ingredients, excipients and pharmaceutical solutions, will showcase its expansive portfolio of excipients, capsules, coatings, and biopharma solutions at AAPS PharmSci 360 2026. The conference and trade show will take place October 26-28 in New Orleans, Louisiana, USA. At Booth 1100 in the exhibit hall, Roquette’s Health & Pharma Solutions team will share their expertise across controlled-release technologies, hydroxypropyl beta-cyclodextrins, and sustainable formulation approaches, alongside a comprehensive portfolio of innovative solutions designed to address the evolving needs of pharmaceutical developers. “AAPS PharmSci 360 is a key opportunity to share our latest innovations, as well as highlight the breadth and depth of our scientific know-how that helps our customers solve complex formulation challenges,” said Peter Freed, Head of Technical Service & Development North America for Roquette’s Health & Pharma Solutions Business Unit. “From a
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