- CIMERLI™ is Coherus’ third FDA-approved product and the first of four new product launches planned by the end of 2023 -
- First CIMERLI™ product sales expected in October 2022 -
- COLUMBUS AMD trial was published in the journal Ophthalmology and demonstrated the clinical equivalence of CIMERLI™ to Lucentis®with a comparable safety and immunogenicity profile -
REDWOOD CITY, Calif., Aug. 02, 2022 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (Coherus or Coherus BioSciences, Nasdaq: CHRS) announced today that the U.S. Food and Drug Administration (FDA) has approved CIMERLI™ (ranibizumab-eqrn) as a biosimilar product interchangeable with Lucentis® (ranibizumab injection) for all five indications, meeting the FDA’s rigorous standards to the reference product, including safety, efficacy and quality.1 CIMERLI™ belongs to the anti-VEGF therapy class of biologics that has been revolutionary in helping retinal patients maintain or gain vision.
“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 U.S. retinal disease community,” said Paul Reider, Chief Commercial Officer of Coherus BioSciences. “Coherus is the only company in the $7 billion anti-VEGF ophthalmology market with a demonstrated track record of U.S. 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.”
“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," said Dr. Peter K. Kaiser, Professor of Ophthalmology at the Cole Eye Institute/Cleveland Clinic, and an advisor to Coherus. "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."
Denny Lanfear, CEO of Coherus BioSciences added, “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.”
Commercial availability of CIMERLI™, in both 0.3 mg and 0.5 mg dosages, is planned for early October 2022. Retina indications for which CIMERLI™ 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). 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
The approval of CIMERLI™ and its determination of interchangeability with Lucentis® is based on a comprehensive analytical, preclinical and clinical program (including the COLUMBUS-AMD study) to confirm equivalent safety and efficacy to Lucentis®.
The COLUMBUS-AMD study, published in the highly-regarded medical journal Ophthalmology, was the head-to-head study where CIMERLI™ met its primary endpoint of change from baseline in best corrected visual acuity (BCVA) at week 8 as compared to 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 Lucentis®.2 Based on the totality of evidence, CIMERLI™ demonstrates that clinical outcomes are expected to be the same for any given patient across all indications. As an interchangeable biosimilar, CIMERLI™ is not expected to result in safety risk or reduction in efficacy in any way, when substituted for Lucentis.1
About CIMERLI™CIMERLI™ (ranibizumab-eqrn) is the only FDA-approved biosimilar interchangeable with Lucentis® for all Lucentis® FDA-approved indications. Formerly CHS-201 (also known as FYB201), it is a biosimilar to the reference product, Lucentis®. CIMERLI™ has the same product attributes with Lucentis®, in terms of the same dosage strengths (0.3 mg, 0.5 mg), same formulation and excipients, and same amino acid sequence. Coherus owns the biologics license application (BLA) and commercial rights in the U.S. and its territories. Coherus licensed CIMERLI™ from Bioeq AG, a joint venture between Polpharma Biologics Group B.V. and Formycon AG.
About interchangeability designation and 12-month exclusivity3An interchangeable biosimilar product is a biosimilar that meets additional requirements outlined by the law that allows for the FDA to approve biosimilar and interchangeable biosimilar medications. An interchangeable biosimilar product may be substituted without the intervention of the health care professional who prescribed the reference product, much like how generic drugs are routinely substituted for brand name drugs. This is commonly called pharmacy-level substitution and is subject to state pharmacy laws. A health care provider also can prescribe an interchangeable biosimilar product just like they would prescribe a biosimilar or a reference product. Because of the FDA’s high standards for approval, health care providers and patients can be confident in the safety and effectiveness of a biosimilar or an interchangeable biosimilar product, just as they would be for the FDA-approved original product.
The first biosimilar with interchangeability status compared to its reference product is entitled to one-year of exclusivity of the interchangeability designation, from the time of first commercial marketing.
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.
3. Biosimilar and Interchangeable Biologics: More Treatment Choices: https://www.fda.gov/consumers/consumer-updates/biosimilar-and-interchangeable-biologics-more-treatment-choices
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:
CONTRAINDICATIONS
WARNINGS AND PRECAUTIONS
Neovascular (wet) age-related macular degeneration
Macular edema following retinal vein occlusion
Diabetic macular edema and Diabetic Retinopathy
ADVERSE REACTIONS