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
LabPMM® Launches Global KMT2A MRD Testing Service to Support Menin Inhibitor Development and Acute Leukemia Care4.8.2026 10:10:00 EEST | Press release
LabPMM®, an Invivoscribe® subsidiary, today announced the global availability of its new KMT2A measurable residual disease (MRD) testing service. The highly sensitive digital PCR service is available to healthcare providers, clinical researchers, and biopharmaceutical partners through LabPMM’s global laboratory network, with CAP/CLIA-accredited testing available in the U.S. The service addresses a growing need for accurate molecular monitoring in acute leukemias.1,2,3 KMT2A rearrangements (KMT2Ar) are oncogenic drivers in acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL).4 These rearrangements are present in about 80% of infant cases and 5-15% of childhood and adult leukemia cases.5 KMT2Ar leukemias are associated with chemotherapy resistance, high relapse rates, and poor clinical outcomes.5 The emergence of menin inhibitors is transforming the therapeutic landscape for patients with AML and ALL, particularly those with KMT2A-rearranged and NPM1-mutated disease.6 The
Mosaic Therapeutics appoints Dr Allison Jeynes as Chair of the Board4.8.2026 10:00:00 EEST | Press release
Mosaic Therapeutics, Ltd, (‘Mosaic’, or ‘the Company’) an oncology therapeutics company developing novel, targeted drug combinations across a range of haematological and solid cancers, today announced the appointment of Dr Allison Jeynes as Chair of the Board to support its next phase of growth and advancement towards clinical development. Allison succeeds Dr Edward Hodgkin, who remains a Non-Executive Director of the Board. Allison is a UK-trained oncologist and highly-experienced life sciences leader, and brings over three decades of drug development and executive experience to Mosaic Therapeutics. As CEO of Avillion, a clinical development company, for the last 13 years, she has led global teams to achieve a 100% success rate from Phase 3 development through to FDA approval for multiple programs spanning oncology, immunology and respiratory medicine. In addition, she raised funds of around $400M as founder and CEO. Across her career she has contributed to 20 drug approvals, engaging
TOHKnet and Adtran conduct Japan’s first 50G PON trial on a live network4.8.2026 10:00:00 EEST | Press release
Adtran today announced that TOHKnet has completed Japan’s first live network trial demonstrating the coexistence of 50G PON, XGS-PON and EPON on a single fiber. Conducted in Sendai using Adtran’s SDX 6400 Series OLT, the demo showed how the platform enables three generations of PON technology to operate together in a live service environment. The results highlight a realistic path for operators to introduce 50G PON capacity while maintaining continuity for existing services, maximizing the value of deployed fiber assets and reducing the complexity and disruption typically associated with network upgrades. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260803353435/en/ Adtran’s SDX 6400 Series is helping TOHKnet demonstrate how Japan’s operators can migrate to 50G PON without disrupting existing PON services. “As demand for digital services continues to grow, this trial is a key milestone for the future of fiber access in Jap
“HATSUNE MIKU LIGHTS TOKYO” Debuts on July 254.8.2026 10:00:00 EEST | Press release
The Tokyo Metropolitan Government has been presenting year-round projection mapping displays on the Tokyo Metropolitan Government Building, using light and sound to showcase a wide range of artistic expressions as part of its efforts to create new nighttime tourism attractions in Tokyo. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260802298570/en/ © Crypton Future Media, INC. On Saturday, July 25, "HATSUNE MIKU LIGHTS TOKYO", featuring the globally beloved virtual singer Hatsune Miku, held its first screening. The work brings the world of the popular song “M@GICAL☆CURE! LOVE ♥ SHOT!” to life across the entire façade of the Tokyo Metropolitan Government Building. Since its launch in February 2024, “TOKYO Night & Light” has welcomed visitors from Japan and around the world, with total attendance surpassing 1.55 million. As one of Tokyo’s emerging landmark attractions, the project continues to captivate audiences through its
Evexta Bio Announces Clinical Trial Collaboration and Supply Agreement with Roche to Evaluate Rupitasertib in Combination with a Selective Estrogen Receptor Degrader in Advanced / Metastatic Breast Cancer4.8.2026 10:00:00 EEST | Press release
Evexta Bio S.A., a precision oncology company, founded by Truffle Capital (founder of Abivax and Carvolix), and focused on the discovery and development of targeted therapies, today announced a clinical collaboration and supply agreement with plans to initiate a Phase 1b study combining its lead investigational compound, rupitasertib, with Roche’s investigational compound giredestrant, a selective estrogen receptor degrader (SERD), for the treatment of ER+, HER2-, ESR1-mutated advanced / metastatic breast cancer. Rupitasertib, is a first-in-class oral dual-node PI3K/AKT/mTOR (PAM) pathway inhibitor, which selectively inhibits S6K and AKT1/3. Rupitasertib was purposefully and rationally designed to target S6K for potent PAM inhibition and AKT1/3 to block the AKT compensatory feedback loop, while sparing AKT2 to avoid hyperglycemia, which we believe will lead to a superior efficacy and safety profile compared to other PAM pathway inhibitors. Under the terms of the agreement, Roche will s
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