Shots: The EC has granted approval to Opuviz 40 mg/mL solution, biosimilar version of Eylea (aflibercept) and will be commercialized by Biogen as per an agreement b/w the companies Approval of SB15 was based on comprehensive data, incl. a P-III study showing equivalent efficacy, safety, immunogenicity & PK profile to aflibercept. It achieved the 1EP…
Shots: The CHMP has granted positive opinion to Opuviz (40mg/mL), a biosimilar to Eylea (aflibercept), for treating wet AMD, visual impairment from macular edema due to RVO, DME & myopic CNV The opinion was based on P-III trial in treatment-naïve nAMD patients (n=449), to receive either Opuviz or Eylea & switching b/w the treatments at…
Shots: The CHMP has granted positive opinion to Opuviz (40mg/mL), a biosimilar to Eylea (aflibercept), for treating wet AMD, visual impairment from macular edema due to RVO, DME & myopic CNV The opinion was based on P-III trial in treatment-naïve nAMD patients (n=449), to receive either Opuviz or Eylea & switching b/w the treatments at…

