Formycon and Klinge Biopharma Reports the US FDA’s Approval of Ahzantive (Biosimilar, Eylea)
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- 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 | Image: FORMYCON
Related News:- Formycon and its License Partner Klinge Biopharma Reports the BLA Submission of FYB203 (Biosimilar, Eylea) to the EMA
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A passionate content writer with expertise in delivering high-quality and engaging content, Dipanshu is a keen reader and a versatile writer. Dipanshu dedicatedly covers news ranging from biopharma, life sciences, biotech, and MedTech to diagnostics and animal health companies. He can be contacted at connect@pharmashots.com
