Formycons & Bioeq AG Receives CHMP Positive Opinion of FYB201 (biosimilar, ranibizumab) as 1L Treatment of Neovascular (wet) Macular Degeneration
Shots:
- The EMA’s CHMP has issued a positive opinion for approval of FYB201, a biosimilar to Lucentis (ranibizumab) for the treatment of patients with wet AMD and other serious ocular diseases incl. DME, PDR, ME due to retinal vein occlusion & CNV. The EC’s decision is expected at the end of August
- The recommendation was based on the P-III study of FYB201 which showed comparable efficacy, safety, PK, and immunogenicity to the reference ranibizumab in patients with wet AMD
- Under the license agreement with Bioeq, Teva has exclusive rights to distribute the product in the EU and other territories and is currently preparing for the launch of FYB201 in the EU
Ref: Formycon | Image: Formycon
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