New injectable approved by the FDA
The FDA approved Cimerli as a biosimilar to and interchangeable with Lucentis, according to a press release from Coherus BioSciences.
The approval confirms that Cimerli (ranibizumab-eqrn), an anti-VEGF therapy that helps patients with retinal diseases maintain or gain vision, meets all FDA safety, efficacy and quality standards. It is indicated for neovascular age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, diabetic retinopathy, and myopic choroidal neovascularization.
Results from the COLUMBUS-AMD study provided evidence that Cimerli’s efficacy and safety profiles were equivalent to Lucentis (ranibizumab, Genentech), according to the release. Cimerli met the primary endpoint of change from baseline in best corrected visual acuity at week 8 compared to ranibizumab and the secondary endpoints of change from baseline in BCVA and change from baseline in retinal thickness at week 48, as well as safety and immunogenicity.
Cimerli is not expected to reduce safety or efficacy when substituted for Lucentis, according to Coherus.
Cimerli, the only biosimilar product interchangeable with Lucentis across all five indications, will provide both greater treatment access and choice for patients, payers, and providers in the U.S. retinal disease community,” Paul Reider, a chief commercial officer of Coherus BioSciences, said in the release.
Cimerli is expected to be commercially available in both 0.3 mg and 0.5 mg doses in October.
Source: FDA -Helio