Coherus’ Cimerli (biosimilar, ranibizumab) Receives the US FDA’s Approval as a First Interchangeable Biosimilar for the Treatment of Retinal Disease
- 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
Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at firstname.lastname@example.org.