A year after launch of these ranibizumab biosimilars, ophthalmologists have been reluctant to embrace them.
After almost a year since their launch, the two Food and Drug Administration-approved ranibizumab biosimilars are finding slow uptake by retina specialists and, according to an analyst who tracks retina drugs, market forces portend little boost going forward.
In the latest edition of its report on ophthalmology biosimilars, the life sciences consultancy Spherix Global Insights (SGI), found that retina specialists’ and general ophthalmologists’ attitudes toward biosimilars have actually soured over the past two years.
Biogen in July 2022 launched Byooviz, the first biosimilar referencing Lucentis (ranibizumab, Genentech/Roche), after the FDA approved it the previous year, pricing it at $1,130 for a single-use 0.5-mg vial (compared to $1,850 for Lucentis), as Retina Specialist previously reported. A month later, the FDA approved Coherus BioSciences’ Cimerli as the first interchangeable Lucentis biosimilar. Coherus launched Cimerli almost instantaneously. Drugs.com quotes Cimerli at $869 a dose.
Interchangeability is a big deal with biosimilars. It means the biosimilar can be used for all indications for which the reference drug is approved. Cimerli is approved for both neovascular age-related macular degeneration and diabetic macular edema. Byooviz is approved only for nAMD.
Price doesn’t matter
Price doesn’t seem to be the mitigating factor in market sluggishness, Chrystal Ferguson, ophthalmology franchise head for SGI, tells Retina Specialist. Rather, it’s more about the declining market position of Lucentis as aflibercept (Eylea, Regeneron Pharmaceuticals) maintains its dominant position and as faricimab (Vabysmo, Genentech/Roche) gains ground.
SGI bases its latest report on a survey of 79 physicians—62 retina specialists and 17 general ophthalmologists who regularly use anti-VEGF medications—done in late May. The company did previous surveys in December 2021 and 2022.
“Ophthalmologists are learning more about biosimilars, they’re understanding the space a bit more, and as they do the concept of interchangeability is not something that they’re wildly comfortable with,” Ms. Ferguson says. But interchangeability doesn’t mean as much for an in-office- administered drug in ophthalmology as it does in, say, rheumatology where patients take their pills at home.
According to SGI’s data, Eylea holds a 43.4 percent market share, with Avastin (bevacizumab, Genentech/Roche) at 34 percent, Lucentis at 9.4 percent and Vabysmo at 7.6 percent filling out the market.
Four factors influencing market
Other factors are impacting biosimilar uptake in retina Ms. Ferguson says. They include:
• Lucentis’ declining market share. “I think as ophthalmologists become more educated and aware and understand the space more, they are becoming a little bit more skeptical about what interchangeability means, but on top of that there’s not a huge added benefit for them or their patients because they’re not using ranibizumab all that readily to begin with,” she says.
• Meager financial incentives for patients, doctors. Payers typically are the primary driver behind biosimilars because they cost less than the reference product, Ms. Ferguson says. “However, when we ask [ophthalmologists] who benefits from those financial incentives, the reporting is commercial insurers, Medicare, the overall healthcare system, but savings to the patient and to the practice are negligible or modest at best.”
• The Avastin factor. Avastin makes the biosimilar landscape in retina unique from other specialties. None have a reimbursable, off-label first-line therapy priced far below biosimilars. Retina specialists feel comfortable with Avastin and it has a proven safety profile, Ms. Ferguson says, although the efficacy doesn’t meet that of ranibizumab or aflibercept. “They can start these patients on treatment right away rather than jump through hoops to get them on a ranibizumab biosimilar, and the price just can’t be beat,” she says. A dose of Avastin costs $67.86, according to the 2022 Medicare fee schedule.
•The buy-and-bill factor. Intravitreal biosimilars require the physician to purchase the drug, store it and then bill for reimbursement when they administer it, a process known as buy and bill. This applies to new products until they establish a reimbursement pathway, Ms. Ferguson says. That hasn’t happened yet for Byooviz and Cimerli, she adds. “Physicians are reluctant to gamble their own money on the reimbursement,” she says. “That’s what we’re dealing with here in the ophthalmology space because they don’t even know up front if they’re going to get reimbursed for this.”
Meanwhile, Eylea biosimilars
Meanwhile, at least eight aflibercept biosimilars are in the pipeline, but they have a larger piece of the market to compete in.
However, Regeneron has developed a high-dose aflibercept 8 mg (Eylea is 2 mg), for which the FDA last month issued a complete response letter (CRL) raising issues with inspection findings at a third-party filler.
The FDA has set a target action date of July 27, 2023, and it isn’t clear how the CRL will impact that. Regeneron also recently reported positive 24-month results of 12- and 16-week dosing regimens with the high-dose aflibercept.
Ms. Ferguson calls the high-dose aflibercept “the next-generation Eylea.” She adds, “I think the idea is to take their 2-mg patients and move them over to 8 mg before the biosimilars actually get there.” Those who stay on 2-mg therapy will have a biosimilar option.
Meanwhile, Vabysmo is picking up market share, Ms. Ferguson says, which is another factor that could further depress the market for Lucentis and its biosimilars.
The SIG report is available at www.spherixglobalinsights.com. RS
— Richard Mark Kirkner
Ocular Therapeutix reported topline 12-month data from its Phase I trial of OTX-TKI, a bioresorbable hydrogel intravitreal implant delivering the tyrosine kinase inhibitor (TKI) axitinib for the treatment of age-related macular degeneration. The treatment group had an 89-percent reduction in treatment burden compared with the intravitreal aflibercept arm receiving treatments every eight weeks.
The company iHealthScreen has submitted a 510(k) medical device application to the Food
The first patient has been dosed in a Phase I trial of AIV007, a broad-spectrum TKI, for the treatment of neovascular AMD and diabetic macular edema, the sponsoring company, AiViva Biopharma, reports. The trial will enroll up to 24 patients who will receive a single periocular injection, and evaluate outcomes over six months.