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Sandoz
NEWS

Sandoz Report the EC’s Approval of Afqlir (Biosimilar, Eylea) to Treat Neovascular Age-related Macular Degeneration (nAMD) 

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…
November 15, 2024

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NEWS

EMA Accepted the Marketing Application of Alvotech’s AVT06 a Biosimilar of Eylea (aflibercept) 

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…
August 15, 2024

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Sandoz
NEWS

Sandoz Reports the US FDA’s Approval of Enzeevu (Biosimilar, Eylea) to Treat Neovascular Age-Related Macular Degeneration 

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…
August 12, 2024

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NEWS

Formycon and Klinge Biopharma Reports the US FDA’s Approval of Ahzantive (Biosimilar, Eylea) 

Shots:  The US FDA has approved Formycon and Klinge Biopharma’s Ahzantive (aflibercept-mrbb), biosimilar of Eylea, for treating Age-Related Neovascular (wet) Macular Degeneration (nAMD) and other serious retinal diseases incl. Diabetic Macular Edema (DME), Diabetic Retinopathy (DR) and Macular Edema following Retinal Vein Occlusion (RVO)  The approval was based on analytical, pre-clinical, clinical and manufacturing data…
June 28, 2024

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NEWS

Formycon and Klinge Biopharma Reports the US FDA’s Approval of Ahzantive (Biosimilar, Eylea) 

Shots:  The US FDA has approved Formycon and Klinge Biopharma’s Ahzantive (aflibercept-mrbb), biosimilar of Eylea, for treating Age-Related Neovascular (wet) Macular Degeneration (nAMD) and other serious retinal diseases incl. Diabetic Macular Edema (DME), Diabetic Retinopathy (DR) and Macular Edema following Retinal Vein Occlusion (RVO)  The approval was based on analytical, pre-clinical, clinical and manufacturing data…
June 28, 2024

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Alvotech & Advanz Pharma
NEWS

Alvotech and Advanz Pharma Team Up to Commercialize AVT06/AVT29 (Biosimilar, Eylea) in Europe

  Shots:  Alvotech has signed an exclusive partnership agreement with Advanz Pharma to supply and commercialize AVT06 (2mg, Low dose) and AVT29 (8mg, High dose), biosimilars of Eylea  As per the agreement, Alvotech will develop & supply the biosimilars and receive an upfront plus subsequent development & commercialization milestones. Advanz Pharma will handle registration &…
June 18, 2024

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NEWS

Biocon’s Yesafili (Biosimilar, Eylea) Receives the US FDA’s Approval for Ophthalmology 

  Shots:  The US FDA has approved Yesafili (aflibercept-jbvf), biosimilar to Eylea, for treating neovascular (wet AMD) age-related macular degeneration as well as visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO), DME & myopic choroidal neovascularization (myopic CNV)  The approval was supported by analytical, nonclinical & clinical data…
May 21, 2024

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Biocon,Bayer and Regeneron
NEWS

Biocon Enters into an Exclusive License Agreement with Bayer and Regeneron for the Commercialization of Yesafili (biosimilar, aflibercept) into the Canadian Market 

Shots:  Biocon, Bayer & Regeneron have signed an agreement to commercialize and distribute Yesafili, the biosimilar version of Eylea (aflibercept) Injections across Canada   Under the terms of the agreement, Biocon has set Jul 1, 2025, as the launch date for Yesafili (2mg NDS for vials and prefilled syringes). Earlier in Mar 2023, Health Canada approved…
March 4, 2024

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