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
Lattice to Showcase Open Control Plane Innovations for AI Infrastructure at OCP Global Summit 202628.9.2026 22:00:00 CEST | Press release
Lattice Semiconductor (NASDAQ: LSCC), the low power programmable and platform firmware leader, today announced its participation in OCP Global Summit 2026. At the event, Lattice and AMI, a Lattice company, will demonstrate how an open control plane can help organizations build secure, scalable, and manageable AI infrastructure from silicon to rack. During the event, Lattice will deliver keynote and technical presentations, showcase open management and control solutions, and host interactive demonstrations highlighting secure platform firmware, infrastructure manageability, AI rack management, quantum-resistant security, connectivity, and modular rack-scale architectures. Together, Lattice and AMI technologies will be in full display, demonstrating how organizations can build open, interoperable infrastructure capable of supporting the growing demands of AI data centers. Who: Lattice Semiconductor and AMI, a Lattice Company What / When:Keynote Presentation – “The Open Control Plane: Fro
SLB Announces Date for Third-Quarter 2026 Results Conference Call28.9.2026 19:17:00 CEST | Press release
SLB (NYSE: SLB) will hold a conference call on October 23, 2026, to discuss the results for the third quarter ending September 30, 2026. The conference call is scheduled to begin at 9:30 a.m. U.S. Eastern time and a press release regarding the results will be issued at 7:00 a.m. U.S. Eastern time. To access the conference call, listeners should contact the Conference Call Operator at +1 (800) 715-9871 within North America or +1 (646) 307-1963 outside of North America approximately 10 minutes prior to the start of the call and the access code is 3440360. A webcast of the conference call will be broadcast simultaneously at https://events.q4inc.com/attendee/293449855 on a listen-only basis. Listeners should log in 15 minutes prior to the start of the call to test their browsers and register for the webcast. Following the end of the conference call, a replay will be available at www.slb.com/irwebcast until October 30, 2026, and can be accessed by dialing +1 (800) 770-2030 within North Amer
Boomi Named a Leader and Secures Highest Score in the Strategy Category in Adaptive Process Orchestration Software Evaluation28.9.2026 17:45:00 CEST | Press release
Boomi recognized as a Leader in evaluation of agentic process orchestration software Boomi™, the data activation company for AI, today announced it has been named a Leader in The Forrester Wave™: Adaptive Process Orchestration Software, Q3 2026. The report evaluated 13 providers, and Boomi achieved the highest score in the strategy category. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260928931590/en/ Boomi Named a Leader and Secures Highest Score in the Strategy Category in Adaptive Process Orchestration Software Evaluation According to the report, Boomi’s “above-par roadmap is driven by a strong internal innovation process that embraces partner input and customer feedback, while recent investments focus on supporting client data sovereignty and control in geographies where sovereignty matters.” The report also cites Boomi's vendor-neutral control plane for agentic automation as allowing it to extend into the process aut
Azalea Vision Enrolls First Patient in Proof-of-Concept Study Evaluating Novel Optical Aperture for Keratoconus and Presbyopia28.9.2026 16:27:00 CEST | Press release
Azalea Vision has enrolled the first patient in its NOA proof-of-concept study, launching the company’s clinical program. The study evaluates a Novel Optical Aperture (NOA) inside a contact lens in two patient groups, keratoconus and presbyopia. Clinical study results are expected to inform the planned first-in-human evaluation of Azalea’s fully integrated smart contact lens platform in Europe and the United States. Azalea Vision, a Belgian healthtech company building the first medical-grade smart contact lens, today announced that it has enrolled the first patient in its NOA proof-of-concept study. The study marks the start of Azalea’s clinical program, following its selection for the European Innovation Council (EIC) Accelerator. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260928982998/en/ Novel Optical Aperture smart lens The study is conducted at Visser Contact Lenses (Netherlands) and the University Hospital Antwerp
Xsolla Releases The Xsolla Report: Mobile D2C Edition28.9.2026 15:00:00 CEST | Press release
New Data From More Than 800 Mobile Web Shops Finds Direct-to-Consumer Has Become a Standard Operating Discipline, With Top Performers Capturing More Than Half of a Title's Revenue Regardless of Studio Size Xsolla, a global commerce company, today released The Xsolla Report: Mobile D2C Edition, a new study examining how direct-to-consumer commerce is performing across mobile games. Drawing on data from more than 800 live Xsolla Web Shops alongside public market and regulatory data, the report shows that D2C has moved past the question of whether it works and into a new phase: studios seeing the strongest results are the ones treating their Web Shop as an operating discipline rather than a one-time build. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260928312597/en/ Graphic: Xsolla Three themes run through the report. First, the gap between a typical Web Shop and a top-performing one is wide, and closing it has little to do
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