FDA approves Cimerli as the first interchangeable biosimilar to Lucentis for all indications
While not the first FDA-approved biosimilar for Roche’s blockbuster drug Lucentis – that being Biogen and Samsung Bioepis’ Byooviz, approved in September for three indications – it is the first and only biosimilar interchangeable with Lucentis across all five retinal disease indications.
Cimerli – which becomes the 37th biosimilar approval in the US - is expected to become commercially available in early October.
As Coherus' second product launch, Cimerli marks a 'strategic inflection point' for the company with more biosimilars in the pipeline for 2022 and 2023.
Cimerli is a vascular endothelial growth factor (VEGF) inhibitor. The retinal indications for which Cimerli is interchangeable are 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).
The safety and efficacy of the drug comparable to Lucentis was assessed via the COLUMBUS-AMD study, published in the medical journal Ophthalmology.
The head-to-head study saw Cimerli meet 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.
“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 $7bn anti-VEGF ophthalmology market with a demonstrated track record of US 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.”
As the first biosimilar with interchangeability status compared to its reference product, Cimerli is entitled to one-year of exclusivity of the interchangeability designation, from the time of first commercial marketing.
An 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.
Upcoming Humira biosimilar launch
Coherus BioSciences hopes that Cimerli will follow in the footsteps of its first product, Udenyca, (pegfilgrastim-cbqv), a pegfilgrastim biosimilar approved by the FDA in 2018 and had net revenues of $326.6m in 2021.
Cimerli is one of two planned product launches this year. It has also submitted a BLA (along with Junshi Biosciences) to the FDA for Toripalimab for the treatment of nasopharyngeal carcinoma, with a target action date of December this year.
And next year, Yusimry (adalimumab-aqvh) is set to join a wave of Humira biosimilars with a July launch (the biosimilar was approved by the US FDA in December).
Denny Lanfear, CEO of Coherus BioSciences say the approval of Cimerli marks a 'strategic inflection point' for the company as it transitions from Udenyca alone to a multi-product revenue stream with a strong focus on biosimilars.
"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.”