Cimerli, First Biosimilar Interchangeable to Lucentis, Set to Launch in the US
Coherus BioSciences announced the commercial availability, beginning October 3, 2022, of Cimerli (ranibizumab-eqrn), a biosimilar product interchangeable with Lucentis (ranibizumab injection) for all approved indications. Cimerli was approved by the FDA in August 2022, having met FDA’s standards of biosimilarity and interchangeability to the reference product, including safety, efficacy and quality.[1]
Cimerli will be available on October 3, 2022, though U.S. specialty distributors at a list price of $1,360.00 and $816.00 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.
"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 company news release. “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.”
“Coherus has both the opportunity and the capability to be very successful with the Cimerli launch, as we start the next leg of our revenue inflection towards our target range of $1.2B to $2.2B in 2026,” said Denny Lanfear, CEO of Coherus BioSciences. “We are well positioned competitively to build upon our very successful Udenyca track record and deliver strong results. 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."
Cimerli is indicated for patients with 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). Cimerli 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]
References
1. CIMERLI™ (ranibizumab-eqrn) U.S. Prescribing Information, August 2022.
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761165s000lbl.pdf