Samsung Bioepis Co., Ltd. and Biogen Inc. (Nasdaq: BIIB) have announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for OPUVIZ™ 40 mg/mL solution for injection in a vial, a biosimilar referencing Eylea2 (aflibercept), also known as SB15.
OPUVIZ is recommended for approval to treat adult patients with neovascular (wet) age-related macular degeneration (AMD), visual impairment due to macular edema secondary to retinal vein occlusion (RVO; both branch and central RVO), diabetic macular edema (DME), and myopic choroidal neovascularization (myopic CNV).
Byoungin Jung, Vice President and Regulatory Affairs Team Leader at Samsung Bioepis, stated, “We are thrilled to have our second ophthalmology biosimilar, OPUVIZ, recommended for approval in Europe. This represents a significant milestone for Samsung Bioepis and, more importantly, for patients with retinal disorders as we work to enhance the availability of essential treatments. The positive opinion reflects our commitment to innovation and increasing patient access to biologic therapies. We remain dedicated to transforming how biologic treatments reach patients and improving their lives through our innovative scientific approaches.”
Ian Henshaw, Global Head of Biosimilars at Biogen, expressed enthusiasm about the CHMP’s recommendation, emphasizing its potential to provide meaningful therapeutic options for individuals affected by retinal vascular disorders. He noted that biosimilars could expand access and deliver significant healthcare savings for treating these complex and often debilitating conditions.
The CHMP’s positive opinion was based on comprehensive evidence, including analytical, non-clinical, and clinical data. A randomized, double-masked, parallel-group, multicenter Phase 3 study demonstrated equivalent efficacy and comparable safety, immunogenicity, and pharmacokinetics between SB15 and the reference aflibercept (AFL). The primary endpoint was achieved in terms of change from baseline in best corrected visual acuity (BCVA) at week 8, with additional analyses at 32 and 56 weeks showing comparability across secondary efficacy, safety, immunogenicity, and pharmacokinetic endpoints.
The CHMP’s positive opinion will be forwarded to the European Commission (EC), which will decide on granting marketing authorization for OPUVIZ. If approved, OPUVIZ will become the second ophthalmology biosimilar in Europe and the fifth biosimilar in Samsung Bioepis’s portfolio, which includes BYOOVIZ™ (ranibizumab), BENEPALI™ (etanercept), IMRALDI™ (adalimumab), and FLIXABI™ (infliximab). In November 2019, Samsung Bioepis and Biogen announced a commercialization agreement for two ophthalmology biosimilars, BYOOVIZ (SB11, ranibizumab) and OPUVIZ (SB15, aflibercept), in the U.S., Canada, Europe, Japan, and Australia.
