Samsung Bioepis, Biogen Announce Positive CHMP Recommendation For OPUVIZ In Europe

(RTTNews) - Samsung Bioepis, and Biogen (BIIB) announced the European Medicines Agency's CHMP has adopted a positive opinion for OPUVIZ 40 mg/mL solution for injection in a vial, a biosimilar referencing Eylea, also known as SB15. OPUVIZ has been recommended for approval in adult patients for the treatment of neovascular age related macular degeneration, visual impairment due to macular oedema secondary to retinal vein occlusion, visual impairment due to diabetic macular oedema, and visual impairment due to myopic choroidal neovascularisation.

OPUVIZ, a biosimilar referencing Eylea1 or aflibercept, is Samsung Bioepis and Biogen's second ophthalmology biosimilar to be recommended for marketing authorization by the European Medicines Agency.