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
HM King Mohammed VI Presides Over the Launch Ceremony of the Aircraft Landing Gear Production Plant Project, Representing an Investment of €280 million by the Safran Group in Morocco13.2.2026 21:10:00 CET | Press release
His Majesty King Mohammed VI, may God assist Him, accompanied by HRH Crown Prince Moulay El Hassan, chaired on Friday at the Royal Palace in Casablanca the presentation and launch ceremony of the project to build a landing gear production factory for Safran in Nouaceur, a project that reinforces Morocco as a destination of choice and a true integrated industrial actor at the heart of the global economy. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260213269786/en/ His Majesty King Mohammed VI, accompanied by HRH Crown Prince Moulay El Hassan, chaired on Friday at the Royal Palace in Casablanca the presentation and launch ceremony of the project to build a landing gear production factory for Safran in Nouaceur Considered one of the largest manufacturing centres in the world for Safran Landing Systems, the plant will represent an investment of more than EUR 280 million, create 500 jobs, and operate on 100% decarbonised energ
Sultan bin Ahmed visits Huawei R&D Centre and SMG in China13.2.2026 18:52:00 CET | Press release
His Highness Sheikh Sultan bin Ahmed bin Sultan Al Qasimi, Deputy Ruler of Sharjah and Chairman of the Sharjah Media Council, visited the Huawei Research and Development Centre and Shanghai Media Group (SMG) in Shanghai, People’s Republic of China. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260213682693/en/ Sultan bin Ahmed visits Huawei R&D Centre and SMG in China (Photo: AETOSWire) His Highness toured Huawei Village, which spans 2.2 million square metres and comprises over 100 buildings and laboratories, employing more than 30,000 staff. He observed the master plan of the village and its key facilities that support the company’s business strategy and product development. He also reviewed the specifications of the buildings, constructed to the highest standards, and the diverse services provided to employees, including restaurants, cafes, entertainment venues, and rest areas. The center also offers easy access via train
Andersen Global tilføjer samarbejdsfirmaet Pi Advisory13.2.2026 17:23:00 CET | Pressemeddelelse
Andersen Global styrker sine kompetencer i Afrika gennem en samarbejdsaftale med Pi Advisory, et finansielt rådgivningsfirma baseret i Angola og med afdelinger i Mozambique og Portugal. Pi Advisory tilbyder en bred række af ydelser, herunder fuld skatteservice, forretningssupport og outsourcing, finansiel rådgivning samt en bred vifte af selskabsrelaterede ydelser, der hjælper kunder med alt fra etablering af nye virksomhedsenheder til at navigere i lokale skatteregler. Firmaet integrerer principper for miljø-, samfunds- og ledelsesmæssige forhold (ESG) i sin drift, hvilket afspejler dets engagement i en bæredygtig forretningspraksis. "Dette samarbejde styrker vores evne til at støtte kunder med komplekse behov på tværs af jurisdiktioner," udtalte António Amaral Correia, partner hos Pi Advisory. "Gennem vores samarbejde med Andersen Global kan vi levere løsninger, der imødekommer de skiftende krav fra kunder på de portugisisktalende markeder såvel som globalt." Mark L. Vorsatz, global
Volue Welcomes TA Associates as New Strategic Investor13.2.2026 11:15:00 CET | Press release
Partnership Strengthens Volue’s Position as a European Leader in Electrification Technology Volue, a global leader in electrification and energy technology, today announced that TA Associates (“TA”), a leading global private equity firm, has joined as a new strategic investor alongside Advent International (“Advent”), Generation Investment Management (“Generation”) and Arendals Fossekompani. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260213436945/en/ Over the past 18 months, Volue has undergone a strategic transformation to sharpen its focus on the energy sector. During this period, Volue divested non-core activities and invested in targeted R&D innovation and strategic acquisitions to further position Volue as a leading provider of integrated technology solutions for power trading and generation, grid optimization, and energy market intelligence. Operating at the center of one of the most mission-critical markets of our
ABB strengthens electrical engineering advisory capabilities in Europe with Premium Power acquisition13.2.2026 10:30:00 CET | Press release
Acquisition strengthens ABB’s ability to deliver system-level advisory support at scale to help critical industries manage increasingly complex electrical infrastructures and safeguard energy resilience Enhances ABB’s Electrification Service division offering in power system studies, grid modelling and electrical risk management for data centers, pharmaceuticals and other critical industries Solidifies ABB at the electrical system level, embedding trusted advisory expertise at the point where operational risks, resilience and performance are defined ABB today announced it has entered into an agreement to acquire Premium Power, a leading electrical engineering consultancy headquartered near Dublin, Ireland. For more than two decades, Premium Power has established its reputation as a trusted advisor to large customers, particularly in data centers, pharmaceutical manufacturing and other mission-critical sectors where electrical resilience, uptime and regulatory compliance are essential.
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