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 shown similar efficacy, safety, PK & immunogenicity in Age-Related Neovascular (wet) Macular Degeneration (nAMD) patients
- MAA was also submitted to the EMA in 2023, the decision of which is anticipated in early 2025
Ref: Formycon and Klinge Biopharma | Image: Formycon and Klinge Biopharma| Press Release
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