Samsung Bioepis Secures European Approval for BYOOVIZ Pre-filled Syringe Formulation
核心洞察
The European Medicines Agency (搜索)'s Committee for Medicinal Products for Human Use has adopted a positive opinion for BYOOVIZ pre-filled syringe, Samsung Bioepis (搜索)' biosimilar to Lucentis (ranibizumab).
The pre-filled syringe presentation offers enhanced safety benefits with decreased risk of endophthalmitis (搜索) compared to vials and provides convenience for administration in ophthalmology practice.
Samsung Bioepis (搜索) will assume full commercial responsibility for BYOOVIZ in Europe starting January 2026, with the pre-filled syringe formulation expected to launch in the second quarter of 2026.
Samsung Bioepis (搜索) Co., Ltd. has received a positive opinion from the European Medicines Agency (搜索)'s (EMA) Committee for Medicinal Products for Human Use (CHMP) for BYOOVIZ pre-filled syringe (PFS), a biosimilar referencing Lucentis (ranibizumab). The approval marks a significant advancement in the company's ophthalmology portfolio, with the new formulation expected to become available in Europe during the second quarter of 2026.
Enhanced Safety Profile and Clinical Convenience
The pre-filled syringe presentation represents the standard of care in ophthalmology, offering multiple advantages over traditional vial formulations. According to clinical evidence, the PFS provides 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 (搜索) versus vials.
BYOOVIZ was initially approved by the European Commission in August 2021 as a single-use vial for intravitreal use (0.5 mg/0.05 ml). The biosimilar is indicated for the treatment of neovascular (wet) age-related macular degeneration (搜索) (AMD), visual impairment due to diabetic macular oedema (搜索) (DME), proliferative diabetic retinopathy (搜索) (PDR), visual impairment due to macular oedema secondary to retinal vein occlusion (搜索) (branch RVO or central RVO), and visual impairment due to choroidal neovascularization (搜索) (CNV).
Commercial Transition and Market Strategy
Samsung Bioepis (搜索) will assume full commercial responsibility for BYOOVIZ in Europe following the complete transition of commercialization rights from Biogen, effective January 2026. This transition was announced in October 2025 and represents a strategic shift in the company's European operations.
"As Samsung Bioepis (搜索) 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."
Company Portfolio and Development Pipeline
Established in 2012, Samsung Bioepis (搜索) has positioned itself as a biopharmaceutical company committed to realizing accessible healthcare through biosimilar development. The company continues to advance a broad pipeline of biosimilar candidates spanning multiple therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, neurology, and endocrinology.
The approval of the BYOOVIZ pre-filled syringe formulation demonstrates Samsung Bioepis (搜索)' commitment to product innovation and quality improvements that address practical clinical needs in ophthalmology practice.