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
Mobius Renewables Acquires Air Liquide’s Biogas Production Activities in the United States, France, Norway, and Sweden4.5.2026 09:45:00 EEST | Press release
Mobius Renewables today announced the closing of the acquisition of Air Liquide’s biogas production activities in the United States, France, Norway, and Sweden. The acquisition includes six operating landfill gas-to-RNG (Renewable Natural Gas) sites in the U.S., five operating farm waste sites in France, and a 51% interest in Redo Biosolutions with production and distribution assets across Norway and Sweden. The acquired portfolio will be a meaningful addition to Mobius Renewables (“the Company”), a global, vertically integrated low carbon fuels platform established in December 2025 by funds managed by IFM Investors to accelerate the development, production, distribution, and commercialization of RNG at scale across North America and Europe. The Company is headquartered in Houston, Texas with additional offices in the United States, France, Norway, and Sweden. With this transaction, the establishment of Mobius Renewables is complete, and GreenGasUSA and the acquired portfolio will oper
Incyte Announces FDA Approval of Jakafi XR™ (ruxolitinib) Extended-Release Tablets for the Treatment of Myelofibrosis, Polycythemia Vera and Graft-Versus-Host Disease2.5.2026 00:28:00 EEST | Press release
Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has approved Jakafi XR™ (ruxolitinib) extended-release tablets for the treatment of adults with intermediate- or high-risk myelofibrosis (MF); adults with polycythemia vera (PV) who have had an inadequate response to or are intolerant of hydroxyurea; as well as adults and children aged 12 years and older with steroid-refractory acute graft-versus-host disease (GVHD) or chronic GVHD after failure of one or two lines of systemic therapy. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260501334677/en/ “The approval of Jakafi XR reinforces Incyte’s leadership in hematology and our focus on meeting the evolving needs of patients with myeloproliferative neoplasms (MPNs) and GVHD,” said Bill Meury, Chief Executive Officer, Incyte. “Jakafi XR offers appropriate patients and physicians a once-daily option, expanding choice without changing the well-
Barilla Hosts Surprise Formula 1® Family Reunion Dinner During Miami Race Weekend1.5.2026 19:08:00 EEST | Press release
A special invitation, a table, and a plate of pasta shared by people who are often apart. That’s all it took for Barilla to bring the spirit of togetherness to Miami during the opening day of the FORMULA 1® CRYPTO.COM MIAMI GRAND PRIX 2026. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260430832316/en/ Barilla hosts Arvid Lindblad, Mikaela Shiffrin, and Nico Rosberg with Chef Massimo Bottura at Torno Subito, where the Formula 1® community came together for a surprise dinner. Barilla, the Official Pasta Partner of Formula 1®, welcomed team members and their families to Torno Subito Miami, the restaurant by three-Michelin-starred Chef Massimo Bottura, with the kitchen led by Chef Bernardo Paladini, for an evening where engines were switched off and everyday life took center stage. The night also celebrated the start of the new partnership between Barilla and the Visa Cash App Racing Bulls (VCARB) Formula 1® Team, a meeting of
TIME Names Xenco Medical one of the TIME100 Most Influential Companies in the World and the Winner of the 2026 TIME100 Impact Award in Health1.5.2026 13:07:00 EEST | Press release
Time Magazine has named pioneering medical technology company Xenco Medical as one of the TIME100 Most Influential Companies in the World and the Winner of the 2026 TIME100 Impact Award in Health. Widely regarded as the most prestigious recognition in business and technology, being selected to the TIME100 List remains the most coveted accolade that a company can achieve globally. The TIME100 Impact Awards are given to only 5 recipients each year, making it the rarest of honors that a company can receive and a profound recognition of transformative, global impact. Xenco Medical was honored by Time as the sole recipient of the TIME100 Impact Award in Health in 2026, signifying its leading, global distinction in impact on healthcare. According to Time Magazine, the TIME100 Most Influential Companies list highlights “companies making an extraordinary impact around the world.” The honor bestowed by Time comes after Xenco Medical was named the 2025 Medical Device/ Diagnostics Company of the
Inspirit Capital Completes Acquisition of Kaplan Languages Group1.5.2026 02:17:00 EEST | Press release
Inspirit Capital, a specialist investor in corporate carve-outs, and Kaplan, the global education company, have announced the completion of Inspirit’s acquisition of Kaplan Languages Group (KLG) from Kaplan. Financial terms are not being disclosed. KLG, a leading global language education platform, comprises Kaplan International Languages, Alpadia Language Schools, Azurlingua, and ESL Education. Inspirit Capital will support KLG in delivering on its ambitious growth plans, whilst continuing its fundamental mission to transform lives through language education. The next phase of ownership will see the development and launch of a refreshed standalone brand identity for KLG, with further announcements to follow on this in due course. KLG will continue to use the Kaplan name under a transitional license from Kaplan, Inc. until a new brand is announced. About Kaplan Languages Group Since 2006, KLG has provided the highest quality language education and cultural immersion experiences. Kaplan
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