Coherus Report Results of CHS-201 (biosimilar, ranibizumab) in COLUMBUS-AMD Clinical Trial for the Treatment of nAMD

Shots:

  • The COLUMBUS-AMD trial evaluates the clinical efficacy, safety & immunogenicity of CHS-201 (q4w for up to 48wks.) vs Lucentis in a ratio (1:1) in 477 patients with newly diagnosed subfoveal nAMD
  • The results showed a mean BCVA improvement from baseline @8wks. with an equal median change in both treatment groups, patients experienced similar reductions in FCP & FCS retinal thickness along with total lesion area. The therapy also showed a similar reduction in the proportion of patients with active CNV leakage & an increase in the fluid-free macula
  • The FDA has accepted the BLA for CHS-201’s review with an anticipated PDUFA date is Aug 2, 2022. If approved, the company plans to launch CHS-201 in the US in H2’22

Click here to read full press release/ article | Ref: Globe Newswire | Image: Coherus

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