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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…

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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…

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Alvotech & Advanz Pharma

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 &…

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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…

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Biocon,Bayer and Regeneron

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…

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Samsung Bioepis

Samsung Bioepis Signs a Collaboration Agreement with Samil Pharma to Co-Commercialize SB15 (biosimilar, aflibercept) for the Treatment of Ophthalmologic Conditions

Shots:  Samsung Bioepis entered into a collaborative agreement with Samil Pharmaceuticals to co-commercialize SB15, a biosimilar version for Eylea (aflibercept) for the treatment of wet age-related macular degeneration (wAMD) & diabetic macular edema (DME) across Korea  Earlier in Jun 2022, both companies had collaborated to jointly commercialize Amelivu, a biosimilar version of Lucentis for the…

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Bayer and Regeneron Receive the EC’s Approval for Eylea (aflibercept, 8mg) for the Treatment of Age-related Macular Degeneration (nAMD) and Diabetic Macular Edema (DME)

Shots:The approval was granted based on the results from the P-III (PULSAR) & P-II/III (PHOTON) clinical trials evaluating the safety & efficacy of Eylea 8mg vs 2mg dosed Q8W following initial monthly dosing in patients (N=1,164) with nAMD & DME. The 1EP of both the studies was non-inferior BCVA changesBoth the studies met…

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Prescription Drugs Based Top 20 2022

Top 20 Prescription Drugs Based on 2022 Total Revenue

Shots:Prescription drugs have an instrumental role in effectively controlling chronic diseases like heart-related conditions, diabetes, arthritis, hypertension, and cancer, among others. Unlike over-the-counter drugs, prescription drugs are advised not to be taken without the authorization of a doctorIn 2022, the global market size of prescription drugs was worth $1035.5B and is envisioned to…

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