Coherus’ Cimerli (biosimilar, ranibizumab) Receives the US FDA’s Approval as a First Interchangeable Biosimilar for the Treatment of Retinal Disease
Shots:
- The US FDA has approved Cimerli as 1st interchangeable biosimilar to Lucentis for 5 indications incl. wet AMD, Macular Edema following RVO, DME, DR, and mCNV. Cimerli is expected to be available in early October 2022 in both 0.3 & 0.5mg dosages
- The approval was based on analytical, preclinical & clinical programs incl. the (COLUMBUS-AMD) study to evaluate Cimerli vs Lucentis. The trial met its 1EPs of change from baseline in BCVA @8wk. & 2EPs included change from baseline in BCVA & FCB retinal thickness @48wks. & showed a clinical equivalence b/w Cimerli & Lucentis with a comparable safety & immunogenicity profile
- Cimerli marks the 3rd US FDA-approved product interchangeable with Lucentis for all approved indications
Ref: GlobeNewswire | Image: coherus biosciences
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