Samsung Bioepis and Biogen Secure EC Approval for OPUVIZ™, Aflibercept Biosimilar
Tuesday, November 19, 2024
Samsung Bioepis in collaboration with Biogen has received European Commission (EC) approval for OPUVIZ™ (SB15), a biosimilar referencing aflibercept.
OPUVIZ is indicated for adult patients to treat neovascular (wet) age-related macular degeneration (AMD), macular oedema caused by retinal vein occlusion (RVO), diabetic macular oedema (DME), and myopic choroidal neovascularisation (myopic CNV).
The product is available as a 40 mg/mL solution for injection in a vial.
The approval is supported by a comprehensive evaluation of analytical, non-clinical, and clinical data. A Phase 3 clinical trial, conducted across multiple centres, demonstrated that OPUVIZ offers comparable efficacy, safety, immunogenicity, and pharmacokinetic profiles to its reference product.
The study's primary endpoint, which measured changes in best corrected visual acuity (BCVA) at week eight, confirmed equivalence between the biosimilar and the reference product. Further analyses at 32 and 56 weeks reinforced the findings.
OPUVIZ is the second ophthalmology biosimilar approved in Europe and is part of Samsung Bioepis' growing portfolio of biosimilars, including treatments such as BYOOVIZ™ (ranibizumab), BENEPALI™ (etanercept), IMRALDI™ (adalimumab), and FLIXABI™ (infliximab).
The collaboration between Samsung Bioepis and Biogen includes commercialisation rights for these products across Europe, the US, Canada, and selected other markets.
This latest approval is expected to enhance treatment accessibility and affordability for retinal disorders while contributing to healthcare sustainability across Europe.
Source: samsungbioepis.com
