Samsung Bioepis Begins Commercialization of BYOOVIZ ® , Biosimilar to Lucentis (Ranibizumab), in Europe
2.1.2026 09:00:00 EET | Business Wire | Press release
Samsung Bioepis Co., Ltd. today announced that the company has begun direct commercialization of BYOOVIZ®, a biosimilar to Lucentis1 (ranibizumab), in Europe. Samsung Bioepis has been working to ensure seamless transfer of commercial rights from Biogen back to Samsung Bioepis, and BYOOVIZ will now be available as a Samsung Bioepis brand across multiple European countries.
“This is a significant milestone for Samsung Bioepis as the company continues to strengthen its presence in Europe by expanding its portfolio of directly commercialized products. Leveraging the past three years of experience with EPYSQLI (eculizumab) and the newly launched OBODENCE (denosumab) and XBRYK (denosumab) in Europe, we will continue on our journey to become a fully integrated biopharmaceutical company with end-to-end capabilities from development to commercialization,” said Antonio Rito, Vice President and Head of Europe, at Samsung Bioepis. “We will work closely with payers and healthcare professionals to ensure seamless access to our biosimilar medicines for patients in need.”
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). In November 2025, European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for BYOOVIZ pre-filled syringe (PFS). The PFS presentation is expected to be available on the European 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 biologic 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 LinkedIn and X.
| __________________________ |
| 1 Lucentis is a trademark of Genentech Inc. |
View source version on businesswire.com: https://www.businesswire.com/news/home/20260102921713/en/
Contacts
MEDIA CONTACT
Anna Nayun Kim, nayun86.kim@samsung.com
Yoon Kim, yoon1.kim@samsung.com
EU CUSTOMER SERVICE CONTACT
EU Customer Service, css.sbeu@samsung.com
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
www.businesswire.com
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
Bureau Veritas Confirms LEAP | 28 Ambition, Upgrades Total Revenue Growth to Double-Digit in 2027 – 2028 1 and Targets EUR1 Billion Revenue in AI-Driven Markets and Services by 203022.9.2026 08:30:00 EEST | Press release
Bureau Veritas (BOURSE:BVI): CAPITAL MARKETS DAY 2026 Today, Bureau Veritas hosts its Capital Markets Day. The Company will present an update on the progress of its LEAP | 28 strategy, building on three years of successful execution. › 2024-2026 achievements: Proven track record: mid-to-high single-digit organic revenue growth (7-8%) delivered across 2023–2026e2, with 115 basis points of adjusted operating margin improvement3; Portfolio transformation on track: c. 21.0% of the portfolio rotated since LEAP | 28 launch, with EUR1.2 billion of revenue acquired, sold or to be exited through 24 acquisitions, 4 divestments and 1 exit; New operating model: the active portfolio management delivered allowed the Company to create a new operating model that simplifies its growth algorithm. Combined with a simplified organization with four divisions and ten Product Lines, it sharpens Bureau Veritas’ position as a focused multi-specialist Company; Driving growth and profitability: through Portfolio
OPM Biosciences Launches Integrated Cell Culture Media-to-Manufacturing Platform for Biosimilar Development22.9.2026 08:00:00 EEST | Press release
OPM Biosciences, a cell culture media and bioprocess solutions company, today announced two new offerings that extend its OPM-CHO™ platform into biosimilar development and manufacturing: the Biosimilar Media Optimization Service and the Sureness™ Biosimilar Platform. Cell culture media can significantly influence cell growth, productivity, and critical quality attributes (CQAs), making media strategy an important component of biosimilar process development. OPM-CHO, the company’s portfolio of chemically defined cell culture media for CHO-based biomanufacturing, has supported more than 390 molecules in clinical and commercial stages worldwide, including biosimilars. Across 35 side-by-side evaluations, OPM-CHO media delivered an average titer improvement of 96% over each program’s original media combinations*. In separate internal studies, OPM-CHO media demonstrated lot-to-lot variability below 5%.* As patent expirations create new opportunities for biosimilar development, achieving a pr
H2SITE Secures €3.4 Million (NOK 39.1 million) in Enova Funding to Scale Onboard Ammonia-To-Power for Commercial Maritime Applications22.9.2026 07:00:00 EEST | Press release
H2SITE has secured €3.4 million (NOK 39.1 million) in funding from Enova for HydraNord Power, a project that will develop and validate a commercial-scale onboard ammonia-to-power system for the maritime sector. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260921324898/en/ Enova is one of the Norwegian government's primary instruments for accelerating the country's climate and energy transition. Its primary responsibility is to manage the Climate and Energy Fund on behalf of the Norwegian government. For H2SITE, Enova’s support is a major milestone in the commercialisation of its onboard ammonia cracking technology, enabling the company to scale from proven maritime demonstrations to replicable commercial solutions for the global shipping industry. Led by H2SITE, HydraNord Power will convert ammonia into high-purity hydrogen directly onboard vessels. The system will produce up to one tonne of hydrogen per day and supply mar
EcoOnline Recognised as a Leader in Verdantix Green Quadrant: EHS Software 2026 for Third Time21.9.2026 19:43:00 EEST | Press release
EcoOnline, the global provider of software that transforms how organisations protect people and the planet, has been recognised for the third consecutive time as a Leader in the independent Verdantix Green Quadrant: EHS Software 2026 report, with market-leading strength in Safety Management. The assessment evaluated leading vendors of environmental, health and safety software vendors across a range of capabilities and customer buying signals. Verdantix recognised EcoOnline’s strength in the areas organisations rely on to protect workers every day: Safety Management, Chemicals Management, AI-enabled Training and Contractor Safety. It reflects the changing needs of EHS buyers, who are increasingly looking for integrated platforms that connect everyday safety with broader operational risk and crisis preparedness. EcoOnline achieved the highest score for Safety Management, reflecting the breadth of the platform’s capabilities across the processes organisations use to identify, mitigate, ma
rhode Announces the Return of Limited Edition Favorites and New Exclusives at Sephora Across Europe and the U.K.21.9.2026 16:00:00 EEST | Press release
rhode, the beauty brand founded by Hailey Rhode Bieber and part of e.l.f. Beauty (NYSE: ELF), has announced that two community-favorite Peptide Lip Tints and a new Sephora-exclusive bag will launch at Sephora across Europe and the U.K. to celebrate the brand’s launch into Sephora in Europe on September 30, 2026. These items will join the brand’s assortment of high-performance skincare and hybrid makeup. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260921199856/en/ rhode announces the return of limited edition favorites and new exclusives at Sephora across Europe and the U.K. To mark the occasion with Sephora across Europe and the U.K., rhode is offering early access to purchase fan-favorite, previously limited edition Peptide Lip Tint in Pretzel at Sephora in Europe and the U.K. on the brand’s launch date September 30, before the product joins rhode’s permanent assortment globally on rhodeskin.com on October 1 and at all r
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