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
Merz Therapeutics to Present Broad Range of Clinical, Real-World and Mechanistic Data at TOXINS 20268.12.2025 08:00:00 CET | Press release
Merz Therapeutics to present more than 20 abstracts and posters at the TOXINS 2026 8th International Conference, taking place January 14-17 2026 in Madrid, Spain. Merz Therapeutics, a leading player in neurology-focused specialty pharma, today announced that the company will present more than 20 clinical and non-clinical abstracts and posters spanning spasticity, movement disorders, and neurotoxin science at the TOXINS 2026 8th International Conference, taking place January 14–17, 2026, in Madrid, Spain. These presentations underscore the company’s commitment to addressing unmet needs in neurological disorders. “Our research reflects a relentless focus on improving patient outcomes through innovation in neurotoxin science,” said Dr. Stefan Albrecht, Chief Scientific and Medical Officer at Merz Therapeutics. “By presenting these new data at TOXINS 2026, we aim to foster scientific exchange and advance treatment strategies that address real-world challenges for patients and clinicians.”
Galderma Welcomes Increased Equity Investment From L’Oréal8.12.2025 07:05:00 CET | Press release
L’Oréal to acquire an additional 10% stake in Galderma recognizing its scientific leadership in dermatology and long-term growth potential Ad hoc announcement pursuant to Art. 53 LR Galderma Group AG (SIX:GALD), the pure-play dermatology category leader, today announced that L’Oréal Groupe intends to increase its equity investment in the company, acquiring an additional 10% stake from Sunshine SwissCo GmbH (a consortium led by EQT, Abu Dhabi Investment Authority (ADIA), and Auba Investment Pte. Ltd., acting as sellers). Following the transaction, which is subject to customary approvals, L’Oréal’s total shareholding in Galderma will rise to 20%, building on its initial investment made in August 2024. The transaction is expected to close in Q1 2026. In connection with this increased investment, Galderma will consider nominating two non-independent board candidates from L’Oréal, replacing the board members representing the consortium led by EQT, at the 2026 Annual General Meeting. Additio
Ant International Wins Champion of NeurIPS Competition of Fairness in AI Face Detection8.12.2025 04:37:00 CET | Press release
The Challenge: Deepfakes undermine both the accuracy and fairness of AI face detection due to variations in human features.The Technology: Ant International’s AI model uses a novel ‘Mixture of Experts’-based Adversarial Debiasing approach to achieve superior fairness and accuracy across diverse demographics.The Impact: This advancement strengthens payment security, offering robust protection against deepfake fraud and enhancing eKYC compliance globally. Ant International, a leading global digital payment, digitisation, and financial technology provider, has won first place at the NeurIPS Competition of Fairness in AI Face Detection. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251207210856/en/ Ant International’s solution takes top spot at the NeurIPS Competition of Fairness in AI Face Detection, emerging first among over 2,100 submissions from 162 teams globally. AI Fairness enhances Financial Security Studies by the Nati
Sonrotoclax Data at ASH 2025 Confirm Foundational Potential Across B-cell Malignancies8.12.2025 00:00:00 CET | Press release
Novel BCL2 inhibitor sonrotoclax monotherapy demonstrates deep and durable clinical responses in R/R MCL and R/R CLLSonrotoclax in combination with BRUKINSA demonstrated rapid MRD negativity in treatment-naive CLL, regardless of high-risk features BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced new data on sonrotoclax, a next-generation investigational BCL2 inhibitor, demonstrating meaningful clinical benefit as monotherapy and in combination across B-cell malignancies. These data were featured at the 67th American Society of Hematology (ASH) Annual Meeting & Exposition in Orlando, Florida. The five presentations highlight durable responses in heavily pretreated patients with relapsed/refractory (R/R) mantle cell lymphoma (MCL) and additional studies showing deep, rapid, and sustained undetectable minimal residual disease (uMRD) rates with sonrotoclax-based combinations in patients with treatment-naive chronic lymphocytic leukemi
Andersen Consulting tilføjer samarbejdsfirmaet Codezilla7.12.2025 21:19:00 CET | Pressemeddelelse
Andersen Consulting styrker sine kompetencer inden for digital transformation gennem en samarbejdsaftale med Codezilla, et firma med hovedsæde i Rumænien, der udvikler specialtilpasset software. Codezilla specialiserer sig i at udvikle skræddersyede softwareprodukter, der løser forretningsmæssige udfordringer gennem en tværfaglig tilgang, som kombinerer softwareudvikling med dybdegående marketingekspertise. Med over 30 år på markedet fungerer firmaet som implementerings- og digital konsulentressource for reklamebureauer, samtidig med at de arbejder med en bred kundebase, herunder virksomheder inden for sundhedssektoren og medicinsk udstyr. Codezillas interne teams strækker sig over teknik, design og strategi og leverer omnichannel-løsninger til både regionale og globale kunder. "Vi tror på, at fantastisk software er resultatet af solid ingeniørkunst og disciplineret eksekvering," udtaler Sebastian Doroftei, administrerende direktør for Codezilla. "Vores samarbejde med Andersen Consulti
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