POLPHARMA-BIOLOGICS
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
TwentyTwo Real Estate and Farallon Capital Complete €761 Million Investment in Isemia, a €1.2bn Healthcare Real Estate Company Created With emeis14.1.2026 18:30:00 CET | Press release
TwentyTwo Real Estate, an independent European real estate investment and management firm, announces the completion, alongside Farallon Capital, of a €761 million investment that led to the creation of Isemia (www.isemiabyemeis.com), a leading healthcare real estate company holding a €1.2 billion portfolio of assets operated by emeis. The transaction represents a significant milestone in TwentyTwo Real Estate’s long-term investment strategy focused on healthcare and operational living real estate. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260114262830/en/ Fachklinik Schömberg Isemia comprises 68 high-quality assets across France, Germany and Spain, with a balanced mix of nursing homes (48%) and clinics (52%). The portfolio benefits from strong fundamentals and resilient operating performance. All properties will continue to be operated by emeis under long-term lease agreements, ensuring continuity of care for residents
AI’s Water Demand to Surge Nearly 130% by 2050 – New Research Shows How to Build a Water-Secure AI Economy14.1.2026 16:00:00 CET | Press release
Analysis finds AI could add 30 trillion liters of annual water demand, but targeted reuse and digital infrastructure investments can substantially offset demand and protect communities The rapid global expansion of artificial intelligence is set to drive a 129% increase in water demand across the AI value chain by 2050, according to new research by Xylem (NYSE: XYL) and Global Water Intelligence (GWI). Watering the New Economy: Managing the Impacts of the AI Revolution provides the most comprehensive assessment to date of how AI is reshaping global water use. It also highlights practical ways to meet that demand while strengthening water security for communities. Spending on AI is forecast to approach $2 trillion in 2026,1 accelerating infrastructure build-out worldwide. By the middle of the century, this expansion is projected to add 30 trillion liters of water demand, annually, fueled by a surge in power generation (~54% of the increase), semiconductor fabrication (~42%), and data ce
ACCELQ Crowned Leader and Customer Favorite in The Forrester Wave™ for Autonomous Testing Platforms14.1.2026 16:00:00 CET | Press release
Agentic Test Automation Pioneer Caps Record-Breaking Year of Growth and "AI-Based Engineering Solution of the Year" Honors Forrester has named ACCELQ a Leader in The Forrester Wave™: Autonomous Testing Platforms, Q4 2025. This marks the third consecutive Wave in which ACCELQ has been recognized as a Leader. Notably, this evaluation placed strong emphasis on generative AI innovation and real-world customer adoption. ACCELQ received the highest scores for both capabilities and vision and was the only platform to be recognized as a Customer Favorite, earning a "double halo" for exceptional customer endorsement. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260113112861/en/ ACCELQ recognized as a Leader and Customer Favorite in The Forrester Wave™️: Autonomous Testing Platforms, Q4 2025, validating its agentic, GenAI-embedded testing vision. According to the Forrester report, ACCELQ received the highest score among all evaluate
Primient to Acquire Full Ownership of Primient Covation, LLC14.1.2026 16:00:00 CET | Press release
Primient, a global leader in biomanufacturing, announced today it has agreed to purchase the remaining ownership interest in Primient Covation, LLC (“Primient Covation”), establishing Primient as the sole owner of the company and marking an exciting new chapter in Primient’s growth in the bioeconomy. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260114344080/en/ This acquisition is the next step of Primient’s strategy to strengthen Primient’s leadership position in biomanufacturing and builds upon recent announcements, including Primient’s partnership with Sustainea and the creation of the iPROOF venture. Primient Covation stands as a leading force in the U.S. biomanufacturing sector, distinguished by its broad range of biomanufacturing and fermentation expertise. The company was founded in 2000 to supply a variety of end markets, including cosmetics and personal care, textiles, fashion, coatings, functional fluids, and oth
BitGo Holdings annoncerer lancering af børsintroduktion14.1.2026 15:53:00 CET | Pressemeddelelse
BitGo Holdings, Inc. ("BitGo"), som er en virksomhed inden for digital infrastruktur til aktiver, annoncerede i dag lanceringen af sin børsintroduktion af 11.821.595 aktier af klasse A-stamaktier i henhold til en registreringserklæring på formular S-1, der er indsendt til det amerikanske finanstilsyn, U.S. Securities and Exchange Commission (kendt som "SEC"). Udbuddet omfatter 11.000.000 aktier af klasse A-stamaktier udbudt af BitGo samt 821.595 aktier af klasse A-stamaktier udbudt af visse eksisterende aktionærer i BitGo. BitGo vil ikke modtage noget provenu fra salget af aktier fra de sælgende aktionærer i forbindelse med udbuddet. I forbindelse med udbuddet har BitGo til hensigt at give konsortiet af garantibanker en 30-dages option til at købe op til yderligere 1.770.000 aktier af klasse A-stamaktier. Den forventede introduktionskurs i forbindelse med børsnoteringen vil ligge mellem 15 og 17 USD pr. aktie. BitGo har ansøgt om at få sine klasse A-stamaktier optaget til handel på New
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