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
Filippo Fagnani from Quanta System Receives the EAU Award for Significant Contribution to Endourology at ICE 202610.10.2026 18:09:00 CEST | Press release
Filippo Fagnani, Marketing & Scientific Director of Quanta System’s Surgical Division, has been honoured with the Award for Significant Contribution to Endourology at ICE26, the International Conference on Endourology organised by the EAU Endourology Section. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261010101303/en/ Filippo Fagnani receiving the prize with Olivier Traxer and Professor Bhaskar Somani. The recognition celebrates more than two decades of professional commitment to laser technology and a career built around a clear ambition: to translate the needs of urologists into increasingly precise, flexible and useful technologies, with the ultimate goal of supporting patient safety and better surgical outcomes. “I have always believed that technology should make the surgeon’s work more precise, more flexible and, most importantly, safer for the patient. My goal has never been to develop technology for its own sake,
Emdoor Information Marks 18 Years of Rugged Computing Excellence with Vertically Integrated Capabilities10.10.2026 12:30:00 CEST | Press release
As industrial automation, smart manufacturing, and field operations increasingly depend on mission-critical mobile computing, global demand for reliable rugged tablets, rugged laptops, and rugged handhelds continues to accelerate. Emdoor Information, a publicly listed company on China’s A-share main board since 2023 and an 18-year veteran in rugged computing, has established itself as a rugged computing solutions provider for industrial customers worldwide. Founded in 2008, the company delivers sustained growth, world-class manufacturing, resilient supply chains, full-stack R&D, and comprehensive lifecycle services. Its rugged computing products and industrial customers now span North America, Latin America, Europe, and Asia-Pacific, serving sectors such as public utilities, intelligent manufacturing, warehouse management, transportation, energy industry. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261010564561/en/ Rugged
Vertex to Present New Data on ALYFTREK® at the North American Cystic Fibrosis Conference9.10.2026 19:15:00 CEST | Press release
- Data on ALYFTREK in children ages 2 to 5 years demonstrate recovery of pancreatic function in some children –- Additional abstracts on clinical and real-world evidence on CFTR modulators also presented - Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced new interim data from the ALYFTREK® (vanzacaftor/tezacaftor/deutivacaftor) 2 to 5 years old open-label extension study, highlighting recovery of exocrine pancreatic function in some children in that age group, allowing those children to discontinue pancreatic enzyme replacement therapy (PERT). Pancreatic exocrine insufficiency in children with cystic fibrosis (CF) was previously believed to be irreversible. These data were presented at the North American Cystic Fibrosis Conference (NACFC). “The data presented at NACFC underscore the safety and efficacy of our CF medicines in the real world and in clinical trials in younger age groups. The data from the Phase 3 open-label study in 2 to 5 year olds evaluating exocrine p
Andersen Consulting udvider med TalentSmartEQ for at fremme lederskab og virksomhedstransformation9.10.2026 18:48:00 CEST | Pressemeddelelse
Andersen Consulting styrker sine kompetencer inden for humankapital gennem en samarbejdsaftale med TalentSmartEQ, en San Diego-baseret virksomhed, der har fokus på at skabe praktiske, engagerende og handlingsorienterede læringsoplevelser med udgangspunkt i emotionel intelligens (EQ) og lederudvikling. I mere end to årtier har TalentSmartEQ arbejdet sammen med organisationer verden over med henblik på at udvikle ledelseskompetencer ved hjælp af emotionel intelligens og dermed styrke medarbejderengagement, teamwork og de samlede resultater. Virksomheden kombinerer forskningsbaserede metoder med praktiske læringsforløb, vurderinger, coaching og skræddersyede programmer, der skal omsætte opbygningen af emotionel intelligens til vedvarende ændringer i adfærden på arbejdspladsen. Som førende aktør i branchen samarbejder TalentSmartEQ med organisationer lige fra Fortune 500-virksomheder til offentlige myndigheder og privatejede virksomheder. "Organisationer stiller stadig større krav til dere
Verdant Rock Receives A (low) Financial Strength Rating from Morningstar DBRS, Adding a Second International Investment-Grade Assessment9.10.2026 16:00:00 CEST | Press release
Verdant Rock now holds Financial Strength Ratings from both Fitch Ratings and Morningstar DBRS, providing counterparties with dual-agency confirmation and reinforcing the security architecture behind each financial guarantee Verdant Rock Limited, a Bermuda Monetary Authority-regulated Class 3B insurance company, has received an A (low) Financial Strength Rating from Morningstar DBRS. The rating reflects Verdant Rock’s financial strength and its capacity to meet policyholder obligations as an investment-grade financial guarantor for Emerging Markets credit. Morningstar DBRS is a global credit rating agency with coverage across North America, Europe, Asia, and Latin America. Its assessment of Verdant Rock reflects the company’s strong projected earnings ability, robust risk profile, sound liquidity, and good capitalization. Morningstar DBRS also assigned an A (low) Issuer Rating to Verdant Rock. The rating follows Verdant Rock’s BBB+ Long-Term Insurer Financial Strength Rating with a Sta
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