Coherus to Launch CIMERLI™ (ranibizumab-eqrn) in the United States on October 3, 2022
- CIMERLI is the first and only FDA-approved biosimilar interchangeable with Lucentis® (ranibizumab injection) for all indications, with 12 months of interchangeability exclusivity -
- Interchangeability designation and clinical equivalence to Lucentis provides confidence that existing Lucentis patients can be safely transitioned to CIMERLI -
- Dedicated retina sales team and CIMERLI Solutions™ patient services hub will ensure successful access and reimbursement -
REDWOOD CITY, Calif., Sept. 19, 2022 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (Coherus or Coherus BioSciences, Nasdaq: CHRS) today 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 is an anti-VEGF therapy within a class of biologics that has been revolutionary in helping retinal patients maintain or gain vision. CIMERLI was approved by the U.S. Food and Drug Administration (FDA) in August 2022, 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," said Paul Reider, Chief Commercial Officer of Coherus BioSciences. “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.”
“A biosimilar that is interchangeable with Lucentis will enable my patients greater treatment access and choice," said David M. Brown MD, FACS, Director of Clinical Research, Retina Consultants of Texas. "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."
“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,” Denny Lanfear, CEO of Coherus BioSciences added. “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 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). 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
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.
Additionally, through CIMERLI Solutions™, Coherus offers healthcare professionals comprehensive practice and patient support that includes extensive patient assistance, industry-leading electronic services, and office support to ensure successful access and reimbursement.
1. CIMERLI™ (ranibizumab-eqrn) U.S. Prescribing Information, August 2022.
IMPORTANT SAFETY INFORMATION & INDICATIONS
CIMERLI™ (ranibizumab-eqrn) is interchangeable* to Lucentis® (ranibizumab injection)
CIMERLI™ (ranibizumab-eqrn), a vascular endothelial growth factor (VEGF) inhibitor, is indicated for the treatment of patients with:
WARNINGS AND PRECAUTIONS
Neovascular (wet) age-related macular degeneration
Macular edema following retinal vein occlusion
Diabetic macular edema and Diabetic Retinopathy
*An interchangeable product (IP) is a biological product that is approved based on data demonstrating that it is highly similar to an FDA-approved reference product (RP) and that there are no clinically meaningful differences between the products; it can be expected to produce the same clinical result as the RP in any given patient; and if administered more than once to a patient, the risk in terms of safety or diminished efficacy from alternating or switching between use of the RP and IP is not greater than that from the RP without such alternation or switch. Interchangeability of CIMERLI™ has been demonstrated for the condition(s) of use, strength(s), dosage form(s), and route(s) of administration described in its Full Prescribing Information
To report SUSPECTED ADVERSE REACTIONS, contact Coherus BioSciences at 1-800-483-3692 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
For additional Safety Information, please see CIMERLI™ Full Prescribing Information available here.
About Coherus BioSciences
UDENYCA®, CIMERLI™, CIMERLI Solutions™ and YUSIMRY™, whether or not appearing in large print or with the trademark symbol, are trademarks of Coherus, its affiliates, related companies or its licensors or joint venture partners, unless otherwise noted. Trademarks and trade names of other companies appearing in this press release are, to the knowledge of Coherus, the property of their respective owners.
Please see Prescribing Information for CIMERLI™ (ranibizumab-eqrn).
Coherus Contact Information:
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