Shots:Formycon & Klinge Biopharma have reported the EC’s approval of FYB203, biosimilar of Eylea (aflibercept), under the brand names: Ahzantive & Baiama valid across the EU plus Iceland, Liechtenstein & Norway after receiving the CHMP’s recommendation in Nov 2024
The biosimilar is intended to treat Age-Related Neovascular (wet) Macular Degeneration (nAMD) and other…
Shots: The P-III trial of Eydenzelt vs Eylea (aflibercept) in diabetic macular edema (DME) patients achieved its 1EP of BCVA improvement at wk.8, demonstrating equivalent efficacy, safety & immunogenicity The P-III study of Stoboclo & Osenvelt vs Prolia & Xgeva (denosumab) in patients (n=479) achieved its 1EP, showing equivalent efficacy in lumbar spine bone mineral…
Shots: The P-III trial of Eydenzelt vs Eylea (aflibercept) in diabetic macular edema (DME) patients achieved its 1EP of BCVA improvement at wk.8, demonstrating equivalent efficacy, safety & immunogenicity The P-III study of Stoboclo & Osenvelt vs Prolia & Xgeva (denosumab) in patients (n=479) achieved its 1EP, showing equivalent efficacy in lumbar spine bone mineral…
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 recommended FYB203 under the brand names, Ahzantive/Baiama, biosimilar version of Eylea (aflibercept), with the decision anticipated in 2nd half of Jan’25 The approval, if granted, will be valid across the whole EU, as well as in Iceland, Liechtenstein & Norway. It is already approved across the US in Jun 2024 FYB203…
Shots: The EC has approved Afqlir(2mg vial kit & pre-filled syringe for intravitreal injection), biosimilar of Bayer’s Eylea (aflibercept), with the launch anticipated in Q4’25 Afqlir's biosimilar development program included analytical, preclinical & clinical data from the Mylight trial, establishing its equivalence in terms of efficacy & safety to the reference medicine Aflibercept is a…
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…
Shots: Alvotech reported EMA’s acceptance of its marketing application for AVT06, a biosimilar to Eylea used to treat eye disorders, and reported global sales of $5.9B. The company expects its marketing approval in Q3’25 Alvotech will develop and supply the AVT06, while Advanz Pharma will register and have exclusive commercialization rights in Europe except for…
Shots: The US FDA has approved Enzeevu, biosimilar version of Eylea (aflibercept), 2mg vial kit & pre-filled syringe for intravitreal injection for enhanced & sustained visual acuity among neovascular age-related macular degeneration (nAMD) patients Approval was supported by the analytical & preclinical in vitro results plus data from Mylight trial, assessing Enzeevu (aflibercept-abzv) vs Eylea in nAMD…
