Cimerli has been approved as an interchangeable product with Lucentis for all five indications, which means the drug meets FDA’s safety, efficacy and quality standards


FDA approves Coherus’ biosimilar product Cimerli. (Credit: Myriams-Fotos from Pixabay)

Coherus BioSciences has received the US Food and Drug Administration (FDA) approval for Cimerli (ranibizumab-eqrn), the company’s biosimilar to Lucentis (ranibizumab injection).

Ranibizumab is developed by Genentech, a subsidiary of Swiss drugmaker Roche, and is commercialised by Novartis under the brand name Lucentis.

The US health agency approved Cimerli as an interchangeable product with Lucentis for all five indications, confirming the drug meets its safety, efficacy and quality standards.

Cimerli is an anti-VEGF therapy that helps retinal patients maintain or gain vision.

Coherus BioSciences chief commercial officer Paul Reider said: “Cimerli, the only biosimilar product interchangeable with Lucentis across all five indications, will provide both greater treatment access and choice for patients, payors and providers in the US retinal disease community.

“Coherus is the only company in the $7bn anti-VEGF ophthalmology market with a demonstrated track record of US commercial biosimilar success.

“We intend to replicate our UDENYCA achievements with a dedicated retina commercial team eager to leverage their experience and in-depth market understanding to drive Cimerli share.”

According to Coherus, Cimerli is the only FDA-approved biosimilar interchangeable with Lucentis for all Lucentis FDA-approved indications.

Cimerli has the same product attributes as Lucentis, in terms of the same dosage strengths, same formulation and excipients, and same amino acid sequence.

The company licensed the drug from Bioeq, a joint venture between Polish pharmaceuticals manufacturer Polpharma Biologics and Germany-based biopharmaceutical firm Formycon.

Coherus advisor Peter K Kaiser said: “Retinal disease is a significant public health issue with certain conditions leading to vision loss or impairment.

“As a practitioner committed to the safety and well-being of patients, having an approved biosimilar product that is interchangeable with Lucentis, with a similar safety and efficacy profile, is great news for patients.

“Ocular anti-VEGF agents have enabled many people with retinal disease to retain and even gain vision. I am pleased to have an additional treatment option for my patients.”

The FDA approval of Cimerli is based on a complete analytical, preclinical and clinical program, including the COLUMBUS-AMD study.

In the head-to-head study, Cimerli has met its primary endpoint of change from baseline in best corrected visual acuity (BCVA), compared to reference ranibizumab.

Coherus intends to start commercialising Cimerli, in both 0.3 mg and 0.5 mg dosages, from early October this year.

The interchangeable indications include Age-Related Macular Degeneration (AMD), Macular Edema following Retinal Vein Occlusion (RVO), Diabetic Macular Edema (DME), Diabetic Retinopathy (DR), and Myopic Choroidal Neovascularization (mCNV).

Coherus BioSciences CEO Denny Lanfear said: “The approval of CIMERLI and its upcoming launch represent a strategic inflection point for Coherus as we transition to a multi-product revenue stream.

“UDENYCA, our first product, established our track record of success competing in the U.S. biosimilars market. Our upcoming launch of CIMERLI and planned launch next year of our third approved product, our Humira biosimilar, YUSIMRY, will leverage this experience and knowledge.

“For Coherus, this portfolio is also our source of internally generated capital as we build a leading innovative oncology franchise that will drive our future growth.”