FDA approves biosimilar product ranibizumab-eqrn for retinal diseases

Coherus BioSciences, Inc. announced earlier this week that ranibizumab-eqrn (CIMERLI) has been approved by the U.S. Food and Drug Administration (FDA) as a biosimilar product interchangeable with ranibizumab injection (Lucentis) for all 5 indications, meeting the FDA’s standards to the reference product including safety, efficacy, and quality, according to a company press release.

Belonging to the anti-VEGF therapy class of biologics, ranibizumab-eqrn will help retinal patients maintain or gain vision. Paul Reider, chief commercial officer of Coherus, said in the release that this will offer greater treatment access and choice for patients, payors, and providers in the US.

Denny Lanfear, CEO of Coherus BioSciences added that the approval of ranibizumab-eqrn and its upcoming launch “represent a strategic inflection point for Coherus as we transition to a multi-product revenue stream.”

Commercial availability of ranibizumab-eqrn, in both 0.3 mg and 0.5 mg dosages, is planned for early October 2022.

Retina indications for which ranibizumab-eqrn is interchangeable include neovascular (wet) age-related macular degeneration (AMD); macular edema following retinal vein occlusion (RVO); diabetic macular edema (DME); diabetic retinopathy (DR); and myopic choroidal neovascularization (mCNV).

Ranibizumab-eqrn is contraindicated in patients with ocular or periocular infections or known hypersensitivity to ranibizumab products or any of the excipients in ranibizumab and ranibizumab-eqrn. Hypersensitivity reactions may manifest as severe intraocular inflammation.¹

The approval of ranibizumab-eqrn and its determination of interchangeability with ranibizumab is based on a comprehensive analytical, preclinical and clinical program (including the COLUMBUS-AMD study) to confirm equivalent safety and efficacy to ranibizumab.

The COLUMBUS-AMD study

The COLUMBUS-AMD study, published in Ophthalmology, was the study where ranibizumab-eqrn met its primary endpoint of change from baseline in best corrected visual acuity (BCVA) at week 8 as compared to reference ranibizumab.

Secondary endpoints included change from baseline in BCVA at 48 weeks, change from baseline in FCB retinal thickness at 48 weeks, safety and immunogenicity. The overall safety and immunogenicity profile was comparable with ranibizumab.²

Based on the totality of evidence, ranibizumab-eqrn demonstrates that clinical outcomes are expected to be the same for any given patient across all indications. As an interchangeable biosimilar, ranibizumab-eqrn is not expected to result in safety risk or reduction in efficacy in any way, when substituted for ranibizumab.¹

References

1. CIMERLI™ (ranibizumab-eqrn) U.S. Prescribing Information, August 2022.
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761165s000lbl.pdf

2. Holz FG, Oleksy P, Ricci F, et al. Efficacy and Safety of Biosimilar FYB201 Compared with Ranibizumab in Neovascular Age-Related Macular Degeneration. Ophthalmology. 2022;129(1):54-63. doi:10.1016/j.ophtha.2021.04.031.