Ranibizumab biosimilar to launch in US

Coherus BioSciences’ ranibizumab-eqrn is the first and only FDA-approved biosimilar interchangeable with ranibizumab injection for all indications, with 12 months of interchangeability exclusivity.

Coherus BioSciences Inc. announced this week that ranibizumab-eqrn (Cimerli) will be available commercially beginning Oct. 3.

According to a news release, ranibizumab-eqrn is a biosimilar product interchangeable with ranibizumab injection (Lucentis, Genentech). It is an anti-VEGF therapy within a class of biologics that has been key in helping retinal patients maintain or gain vision.

The company noted in the news release that ranibizumab-eqrn received FDA approval in August, having met FDA’s standards of biosimilarity and interchangeability to the reference product, including safety, efficacy and quality.1

"With the upcoming launch of Cimerli, retina specialists, patients and payors can expect the same efficacy and safety as Lucentis delivered with the comprehensive savings and patient support services that Coherus is known to deliver," Paul Reider, chief commercial officer of Coherus BioSciences, said in a statement. “We look forward to competing in this large and growing market with our dedicated and experienced retina sales team, leveraging our proven commercial expertise as we accelerate adoption of CIMERLI over the coming months.”

David M. Brown MD, FACS, director of Clinical Research, Retina Consultants of Texas, noted in the news release that a biosimilar that is interchangeable with ranibizumab injection will enable his patients greater treatment access and choice.

“With the same five FDA-approved indications, clinical equivalence to Lucentis in terms of efficacy and safety, and the same dosage strengths, I believe that Cimerli will address biologic treatment costs without compromising safety and clinical outcomes,” he said in a statement.

Moreover, Denny Lanfear, CEO of Coherus BioSciences, noting that his company has both the opportunity and the capability to be very successful with the ranibizumab-eqrn as it reaches for growth goals over the coming years.

“We are well positioned competitively to build upon our very successful UDENYCA track record and deliver strong results,” he said in the news release. “As a company, we embrace high performance in everything we do, while valuing our patient-centric approach to our mission. These qualities make me incredibly proud of our accomplishments and the broader Coherus team."

Ranibizumab-eqrn is indicated for patients with 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 Lucentis and CIMERLI. Hypersensitivity reactions may manifest as severe intraocular inflammation.1

According to the company, ranibizumab-eqrn will be available on Oct. 3, 2022, though U.S. specialty distributors at a list price of $1,360 and $816 per single-dose vial for the 0.5 mg and 0.3 mg dosages respectively. This represents a 30% discount from the list price of the reference product, according to the news release.

The company also noted that it will be offering ophthalmologists practice and patient support that includes extensive patient assistance, industry-leading electronic services, and office support to ensure successful access and reimbursement.

Reference

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