The onslaught of biosimilars to Roche’s anti-VEGF eye med Lucentis is well underway. And come fall, patients may be able to pick up a copycat at the pharmacy with as little fuss as it takes to buy a generic of a small-molecule drug.
The FDA has given the thumbs-up to Coherus BioSciences’ interchangeable Lucentis biosim Cimerli. With the nod, Coherus is preparing for a launch in October, the company said in a release.
Coherus’ product isn’t the first U.S. biosimilar to Roche’s $1.4 billion (PDF) drug—that distinction belongs to Biogen and Samsung Bioepis' deeply discounted Byooviz. Still, Cimerli does hold the crown as the first interchangeable Lucentis biosim.
An interchangeability tag means Coherus’ product can be substituted for its brand-name counterpart right at the pharmacy counter, depending on state pharmacy laws, the FDA said in a biosimilar fact sheet. The regulator describes the process as being “much like how generic drugs are routinely substituted for brand-name drugs.”
Cimerli represents Coherus' third FDA approval. The interchangeable biosim makes up one of four new product launches the company hopes to stage before the end of 2023.
The biosimilar's label covers all five of Lucentis’ nods in macular degeneration, macular edema, diabetic macular edema, diabetic retinopathy and myopic choroidal neovascularization, Coherus said. Coherus plans to roll out Cimerli to the market in 0.3-mg and 0.5-mg dosages in early October.
While Cimerli wasn't the first med to enter the Lucentis biosim fray, its label gives the copycat two clear "advantages" over Byooviz, Mizuho Securities analysts wrote in a note to clients late Tuesday. The first boon from the FDA is Cimerli's interchangeability nod, naturally. But equally important, Cimerly nabbed all of Lucentis' reference indications, while Byooviz only picked up three, the analysts said.
One ace Roche could still have up its sleeve? Delivery. Both biosimilar products now approved for Lucentis still come in glass vials, while Lucentis is approved in an easier-to-use prefilled syringe, the Mizuho team pointed out.
Meanwhile, Coherus CEO Denny Lanfear said in a statement the company has hit a “strategic inflection point.” Aside from the upcoming launch of Cimerli, Coherus late last year won approval for its Humira biosimilar Yusimry, which it plans to launch in 2023, the CEO noted.