FDA approves Cimerli as interchangeable biosimilar to Lucentis
Click Here to Manage Email Alerts
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, 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.
Perspective
Back to Top
Biosimilars can present great advantages for our field. First and foremost, we are already aware of socioeconomic disparities that drive health care decisions and limit the visual gains that we would expect to see in comparison to registration studies. By lowering the cost, it may lead to increased adherence because, at this time, many discontinue treatment because they cannot afford it. In addition, practices carry significant overhead from buy-and-bill drugs, so this might allow for others to use branded drugs again, enabling patients to receive these treatments.
The caveat to this is that the biosimilars need to demonstrate safety at the level of the branded drug. In addition, the phase 3 studies have not built scientifically compelling evidence other than to show that there is equivalence. Hopefully phase 4 studies will help with our understanding of age-related macular degeneration treatment and the safety profile of these biosimilar drugs.
Read more about
Click Here to Manage Email Alerts