Pre-filled Syringe Presentation of BYOOVIZ®, Samsung Bioepis' Biosimilar to Lucentis (Ranibizumab), Gains European Approval
2.12.2025 07:00:00 CET | Business Wire | Press Release
Samsung Bioepis Co., Ltd. today announced that the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for BYOOVIZ® pre-filled syringe (PFS), a biosimilar referencing Lucentis1 (ranibizumab). BYOOVIZ was first approved by the European Commission (EC) in August 2021 as a single use vial for intravitreal use (0.5 mg/0.05 ml) for the treatment of neovascular (wet) age-related macular degeneration (AMD), visual impairment due to diabetic macular oedema (DME), proliferative diabetic retinopathy (PDR), visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) and visual impairment due to choroidal neovascularization (CNV).
The PFS presentation is regarded as the standard of care in ophthalmology, providing convenience for administration with precise dosing and ease of use with syringe injection, as well as safety benefits in the form of a decreased risk of endophthalmitis versus vials.2
“As Samsung Bioepis starts to commercialize BYOOVIZ in January 2026, the addition of this PFS presentation will provide additional value for our stakeholders, by helping providers manage ophthalmic conditions with convenience for injection,” said Antonio Rito, Vice President and Head of Europe at Samsung Bioepis. “We will continue to provide biosimilar medicines with improved product features to meet the needs of healthcare providers and patients.”
In October 2025, Samsung Bioepis announced that the company will assume full commercial responsibility for BYOOVIZ in Europe upon full transition of Biogen’s commercialization rights back to Samsung Bioepis effective as of January 2026. The PFS presentation is expected to be available in the market starting in the second quarter of 2026.
About Samsung Bioepis Co., Ltd.
Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biosimilar candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, neurology, and endocrinology. For more information, please visit www.samsungbioepis.com and follow us on social media – LinkedIn, X.
1 Lucentis is a trademark of Genentech Inc.
2 Uzzan J, Mapani A, Cox O, Bagijn M, Saffar I. Clinical Outcomes and Experiences with Prefilled Syringes Versus Vials for Intravitreal Administration of Anti-VEGF Treatments: A Systematic Review. Ophthalmol Ther. 2024 Sep;13(9):2445-2465. doi: 10.1007/s40123-024-01002-0. Epub 2024 Jul 27. PMID: 39066961; PMCID: PMC11341511.
View source version on businesswire.com: https://www.businesswire.com/news/home/20251201515215/en/
Contacts
MEDIA CONTACT
Anna Nayun Kim, nayun86.kim@samsung.com
Yoon Kim, yoon1.kim@samsung.com
(c) 2024 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
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
The Estée Lauder Companies Fully Establishes Its “One ELC” Operating Model and Reaches Milestone in Its Profit Recovery and Growth Plan1.4.2026 23:00:00 CEST | Press Release
The Estée Lauder Companies Inc. (NYSE: EL) today announced WPP as its first-ever global media partner, marking a significant advancement of its One ELC operating model, a scalable system designed to operate faster, execute with greater discipline, and drive growth. In fully establishing One ELC, the Company also reached a significant milestone in its Profit Recovery and Growth Plan’s (PRGP) Restructuring Program — a key action plan priority of Beauty Reimagined. Stéphane de La Faverie, President and Chief Executive Officer, The Estée Lauder Companies, said, “With the appointment of WPP as our first-ever global media partner, our One ELC operating model is now fully established. This more unified and scalable system will enable us to be faster, more agile and efficient, and support unlocking additional growth. Together with our execution progress, we are confident that we are on a trajectory to deliver sustainable, profitable long-term growth.” de La Faverie added, “Building on our stro
Visual Bank Expands “Qlean Dataset” to Support Large-Scale Japanese Speech Foundation Models1.4.2026 21:45:00 CEST | Press Release
Visual Bank Inc. (CEO: Saneyuki Nagai), through its subsidiary amanaimages Inc., one of the largest digital asset providers for the marketing and advertising industry in Japan with over 40 years of history, today announced the expansion of its Qlean Dataset, a premium AI training data solution designed for developers building high-performance Japanese speech foundation models. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260401752248/en/ Visual Bank Group, leveraging over 40 years of expertise through amanaimages Inc., expands Qlean Dataset, delivering high quality, rights cleared Japanese language corpora, including 100,000+ hours of commercially usable audio. A new development within the Qlean Dataset division, which focuses on providing datasets for institutions engaged in research and development, with rights cleared for AI training and large-scale data applications, has positioned the company as a leading provider of
Manna Air Delivery Raises $50Million Series B as It Announces Plans to Expand in the United States1.4.2026 18:00:00 CEST | Press Release
Manna Air Delivery, a global leader in consumer drone delivery, has announced a $50 million funding round to scale its proven operations further in the United States and Europe. The round brings Manna’s total funding to $110million. Manna now operates one of the most active consumer drone delivery networks in the world, with more than 250,000 regulated commercial UAV flights completed. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260310714366/en/ Manna Air Delivery raises $50m Series B Investors in the round include ARK Invest, known for backing companies such as OpenAI, Anthropic, Tesla and SpaceX, the Ireland Strategic Investment Fund (ISIF) and Schooner Capital, alongside existing investors Coca-Cola HBC and Molten Ventures. As an unmanned aerial vehicle (UAV) delivery pioneer, Manna has operated in six locations across its native Ireland, as well as in Finland and Texas over the past seven years, delivering items inclu
Bureau Veritas Launches an Independent AI Assessment Offering for European Enterprises, Developed in Partnership with Amazon Web Services (AWS)1.4.2026 17:45:00 CEST | Press Release
Bureau Veritas, a global leader in Testing, Inspection, and Certification services (TIC), announces the launch of an AI systems audit to help European enterprises assess and demonstrate their compliance with the European Union's "AI Act" regulatory requirements. This offering combines on-site audits, document analysis, and direct testing to deliver an independent maturity report. Since the EU's AI regulation came into force in 2024, companies have faced major implementation challenges. According to a recent report*, 68% of them struggle to interpret the provisions of the text, while 60% have yet to put in place the governance needed to comply. Non-compliance can cost them up to 7% of annual revenue. Bureau Veritas has developed this new audit offering to help companies identify their compliance gaps and remedy them. Bureau Veritas's new audit offering comprises a pre-audit, document review, on-site audit, and direct testing, resulting in an independent report on the client's AI maturit
Greenland Resources Signs Eight Year Off-take Agreement With SSAB to Supply High Quality Molybdenum1.4.2026 16:29:00 CEST | Press Release
Greenland Resources Inc. (TSX:MOLY, FSE:M0LY) (“Greenland Resources” or the “Company”) is pleased to announce the Company has signed a binding off-take agreement with SSAB, a Nordic and US-based steel producer headquartered in Sweden. The company is a leading producer on the global market for advanced high-strength steels providing solutions to the defence, automotive, infrastructure and energy industries. A stock exchange press release from SSAB can be found on their website at www.ssab.com This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260401270749/en/ The off-take agreement provides an established price floor and price ceiling and will allow SSAB to secure high quality low carbon emission ferromolybdenum extracted in Greenland and refined in Belgium. SSAB will be able to ensure a stable and responsibly sourced long term secured primary molybdenum supply with high sustainability standards and low scope 1&2 emissions from a
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