Coherus pulls first interchangeable biosimilar win for Lucentis copycat
Move over, Lucentis. The FDA has approved the first interchangeable biosimilar to Roche’s blockbuster anti-VEGF drug.
Coherus’ Cimerli is expected to hit the market in October after getting the FDA’s thumbs-up in five retinal indications, the company announced on Tuesday. Cimerli isn’t the first biosimilar to rival Roche’s eye drug — but it is the first to win interchangeable status, meaning it can be substituted at the pharmacy in some cases.
“We’ve hired a dedicated retina sales team, all of whom have years of experience selling to retina specialists,” a Coherus spokesperson said in an email to Endpoints News.
Lucentis, also known as ranibizumab injection, was first approved back in 2006 for wet AMD, a chronic eye disorder that can lead to blindness. It has since picked up a suite of indications, from diabetic retinopathy (DR) to diabetic macular edema (DME).
Cimerli is approved to treat wet AMD, DR, DME, macular edema following retinal vein occlusion (RVO), and myopic choroidal neovascularization (mCNV).
While Lucentis raked in $1.4 billion last year, the market is a bit more crowded now. Samsung Bioepis and Biogen snagged approval earlier this year for the US’ first Lucentis biosimilar, Byooviz, in three indications including wet AMD. While Biogen and Samsung priced Byooviz at a roughly 40% discount to Lucentis, according to Mizuho’s Salim Syed, Coherus has not yet commented on pricing.
Coherus noted Cimerli’s interchangeable status and positive head-to-head results, adding that: “These combined will give retinal specialists a high degree of confidence to prescribe CIMERLI for patients currently receiving Lucentis as well as for any newly diagnosed new patient within indication, and our market research confirms that depending on access and practice economics, opportunity exists to expand CIMERLI use into Avastin and Eylea.”
Roche’s Genentech, however, isn’t going down without a fight. Back in October, the pharma giant got approval for Susvimo, a new ranibizumab administration route that allows wet AMD patients to ditch their current monthly injections and opt instead for as few as twice-annual treatments.