FDA approves ranibizumab-eqrn as a biosimilar product interchangeable with ranibizumab injection for all five indications

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

Coherus BioSciences Inc. announced that the U.S. Food and Drug Administration (FDA) has approved ranibizumab-eqrn (CIMERLI) as the first and only interchangeable biosimilar to ranibizumab injection (Lucentis) for all five indications, with 12 months of interchangeability exclusivity, meeting the FDA’s standards to the reference product, including safety, efficacy and quality.¹

Ranibizumab-eqrn belongs to the anti-VEGF therapy class of biologics that has been revolutionary in helping retinal patients maintain or gain vision.

Ranibizumab-eqrn will provide both greater treatment access and choice for patients, payors and providers in the U.S. retinal disease community, said Paul Reider, Chief Commercial Officer of Coherus BioSciences.

Denny Lanfear, CEO of Coherus BioSciences added, “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, published in the journal Ophthalmology, was the head-to-head study where ranibizumab-eqrn met its primary endpoint of change from baseline in best corrected visual acuity (BCVA) at week 8 as compared with 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