On August 2, 2022, Coherus BioSciences announced 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. Coherus plans to launch CIMERLI" in early October 2022.
In order for a biosimilar to acquire the "interchangeable" designation, in addition to meeting the requirements for a biosimilar (i.e., highly similar to, and no clinically meaningful differences from, an approved reference product), the manufacturer must show that the interchangeable biosimilar product is expected to produce the same clinical result as the reference product in any given patient. For biological products administered more than once to an individual patient, the manufacturer needs to further provide data ensuring that the risk in terms of alternating or switching between use of the interchangeable biological product and its reference product is not greater than the risk of using the reference product without switching.
The benefit of meeting these more extensive requirements is that, just like with a traditional generic drug, an "interchangeable" biosimilar can be substituted for the often pricier reference product by a pharmacist without the prescribing doctor's intervention or approval (subject to state pharmacy laws). Importantly, CIMERLI" will benefit from 12 months of first interchangeable biosimilar exclusivity.
CIMERLI" belongs to the anti-VEGF therapy class of biologics that has been revolutionary in helping retinal patients maintain or gain vision. 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", 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. "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."
Coherus CEO Denny Lanfear explained that 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."
CIMERLI" will follow Samsung Bioepis and Biogen's Byooviz (ranibizumab-nuna) into the market although CIMERLI" will be benefit from interchangeable exclusivity. It will be interesting to see how the landscape for ranibizumab products and pricing changes with the launch of CIMERLI".
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