POLPHARMA-BIOLOGICS
4.10.2021 11:33:12 CEST | Business Wire | Press release
Polpharma Biologics Group announces that its joint venture company with Santo Holding (Strüngmann Group), Bioeq, has received notification by the U.S. Food and Drug Administration (FDA) that the biologics license application (BLA) for its proposed biosimilar (formally also known as BQ201, FYB201, CHS-201) to Lucentis® , a blockbuster ophthalmological drug containing ranibizumab as active drug substance, has been accepted for review.
The FDA has assigned a target action date for the application for August 2022.
The reference product is a monoclonal anti-angiogenic antibody fragment (Fab) that has been approved to treat the "wet" type of age-related macular degeneration, a common form of age-related vision loss. 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.
This file acceptance represents the most recent milestone for Bioeq`s ranibizumab biosimilar program and compliments marketing authorization applications submitted to EMA in June and UK MHRA in July this year.
Subject to the FDA`s approval, BQ201 will be exclusively commercialized by Coherus BioSciences, Inc. in the United States.
Dr Joerg Windisch, CEO of the Polpharma Biologics Group, commented on the achievements of the joint venture:
“This file acceptance is validation of the huge effort put in by the team at Bioeq and its partners to bring treatment choice and improved patient access to the US market. It creates real promise for those who suffer from debilitating vision loss, including age-related macular degeneration.”
- Lucentis® is a registered trademark of Genentech Inc.
Information for editors
About Ranibizumab biosimilar
Bioeq`s proposed ranibizumab biosimilar BQ201, 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20211004005408/en/
Link:
Social Media:
About Business Wire
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
STARTEEPO Invest Announces 5% Stake in Xerox Holdings Corporation15.5.2026 18:15:00 CEST | Press release
STARTEEPO Invest (“STARTEEPO”), an alternative investment fund focused on public equity opportunities, today announced that it has acquired a significant ownership position in Xerox Holdings Corporation (“Xerox” or the “Company”). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260515594020/en/ As of the date of this release, STARTEEPO and its affiliates beneficially owns 6.6 million shares of Xerox (excluding options), representing approximately 5.05% of the Company’s outstanding common stock. STARTEEPO has filed a Schedule 13D with the U.S. Securities and Exchange Commission (the “SEC”) providing additional details regarding its investment. Investment Perspective STARTEEPO believes that Xerox represents an interesting investment opportunity supported by a combination of balance sheet initiatives, ongoing operational improvements, and its position within a changing and consolidating industry. In STARTEEPO’s view, the Company
NTT DATA Announces Intent to Acquire WinWire to Scale Enterprise AI Adoption and Accelerate Industry Transformation with Microsoft15.5.2026 16:00:00 CEST | Press release
Accelerates AI‑driven transformation through expanded agentic AI and data engineering capabilities that underpin NTT DATA’s AI strategy Adds 1,000 Azure engineers and AI specialists to scale cloud and AI delivery capabilities Advances NTT DATA’s North America leadership position, scaling industry aligned AI led innovation across its cloud services and Microsoft Business Unit Builds on NTT DATA’s position as the fastest-growing Microsoft GSI partner, accelerating co-innovation in enterprise AI NTT DATA, a global leader in AI, digital business and IT services, today announced it has signed a definitive agreement to acquire WinWire,an award-winning Microsoft partner specializing in Agentic AI, AI on Azure, data engineering and cloud-native development as foundational capabilities for enterprise AI. The acquisition strengthens NTT DATA’s position as a trusted partner to help organizations move beyond experimentation to operationalize AI at scale. The acquisition further advances NTT DATA’s
NTT DATA Announces Intent to Acquire WinWire to Scale Enterprise AI Adoption and Accelerate Industry Transformation with Microsoft15.5.2026 16:00:00 CEST | Press release
Accelerates AI‑driven transformation through expanded agentic AI and data engineering capabilities that underpin NTT DATA’s AI strategy Adds 1,000 Azure engineers and AI specialists to scale cloud and AI delivery capabilities Advances NTT DATA’s North America leadership position, scaling industry aligned AI led innovation across its cloud services and Microsoft Business Unit Builds on NTT DATA’s position as the fastest-growing Microsoft GSI partner, accelerating co-innovation in enterprise AI NTT DATA, a global leader in AI, digital business and IT services, today announced it has signed a definitive agreement to acquire WinWire,an award-winning Microsoft partner specializing in Agentic AI, AI on Azure, data engineering and cloud-native development as foundational capabilities for enterprise AI. The acquisition strengthens NTT DATA’s position as a trusted partner to help organizations move beyond experimentation to operationalize AI at scale. The acquisition further advances NTT DATA’s
Experian Expands Agent Trust Partner Ecosystem with Akamai to Advance Trusted AI Driven Commerce15.5.2026 15:00:00 CEST | Press release
Collaboration strengthens secure, scalable agentic commerce and supports emerging Know Your Agent standards Experian today announced that Akamai Technologies has joined its growing partner ecosystem, designed to further advance secure, trusted AI driven commerce through the Experian Agent Trust™ framework, alongside partner Skyfire supporting emerging payment innovation. As AI agents begin to search, decide, and transact autonomously, they introduce a fundamental challenge for businesses: how to trust an action when it is no longer directly initiated by a human. Without a verified connection between humans and AI agents, autonomous commerce introduces new risks in fraud, misrepresentation, and unauthorized transactions. Experian Agent Trust is designed to address this challenge by establishing identity, accountability, and trust in agent driven interactions. “Trust, security, and performance must scale alongside the growing role of AI agents in digital commerce,” said Kathleen Peters,
The LYCRA Company and Dukane Advance Ultrasonic Bonding for Nonwovens at INDEX™ 2615.5.2026 14:00:00 CEST | Press release
LYCRA FUSION™ Fiber for Personal Care Applications Debuts The LYCRA Company, a global leader in innovative and sustainable fiber solutions for the personal care industry, and Dukane, a manufacturer of ultrasonic bonding technologies for the hygiene and nonwovens market, are showcasing their latest co-developed advances in ultrasonic bonding at INDEX™ 26, taking place in Geneva, Switzerland, from May 19–22. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260515514441/en/ Join The LYCRA Company and Dukane at INDEX™ 26 in Geneva, as they showcase their latest advances in ultrasonic bonding for nonwovens, including new LYCRA FUSION™ fiber for personal care that delivers superior snapback. Since 2014, both companies have collaborated to advance ultrasonic bonding solutions that help diaper manufacturers improve product softness, fit, and performance while reducing energy consumption, material waste, and maintenance costs. Ultrason
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