Last year was one of the 'most eventful in US biosimilars history,' but these analysts say 2022 should be 'a turning point'
Though last year saw fewer market entrants in the biosimilar space than years past, Cardinal Health still called it one of the “most eventful” in US biosimilars history, acknowledging several key approvals that have the potential to make a big splash.
“This past year, the promise of biosimilars has started to become a reality, as greater competition for some of the costliest biologic treatments on the market is beginning to drive meaningful cost savings,” Sonia Oskouei, VP of biosimilars at Cardinal, wrote in the company’s recently released report.
Last year’s milestones include the approval of Viatris’ Semglee as the first interchangeable biosimilar, the first OK for a biosimilar in ophthalmology, and the first interchangeability designation for a biosimilar to AbbVie’s blockbuster Humira. Looking to the next few years, Cardinal Health says these pivotal drugs will serve as case studies on how payers, pharmacy benefit managers (PBMs) and the pharma industry will react to the burgeoning field.
The sluggish advancement of biosimilars — cheaper treatments that are just as safe and effective as their costly originals — kicked off in 2010, when the Biologics Price Competition and Innovation Act established an abbreviated pathway to FDA approval.
The first biosimilar — Zarxio, a version of Amgen’s white blood cell booster Neupogen — won approval in 2015. Since then, 32 others have been approved, 21 of which have already hit the market. But that isn’t to say it’s been easy. Biosimilars have been met with fierce opposition from pharma companies making top-dollar on their original biologics — the latter successfully delaying launches for 10 of the 33 currently approved biosimilars through patent litigation.
However, the adoption of biosimilars tends to accelerate quickly after market introduction, according to Cardinal Health. And their use has grown significantly since 2015.
Momentum is “stronger than ever” in the biosimilar space, Cardinal Health’s specialty solutions president Heidi Hunter said. Last year, Viatris’ Semglee became the first interchangeable biosimilar, meaning it can be substituted for the original insulins without a doctor’s input. The drug references Sanfoi’s long-acting insulin, Lantus.
Upon launching in November, Viatris said the list price would be set at about $400 for a package of five 3 mL pens, which is about $20 cheaper than the list price for the branded version. The company also simultaneously launched an unbranded version of its insulin glargine product at a 65% list price discount, which the company called “the lowest WAC for any insulin glargine pen on the market to date.”
Though as Chevon Rariy, VP and chair of virtual health at Cancer Treatment Centers of America, noted in the report, “As insulin interchangeable biosimilar products hit the market, only time will tell if they deliver on their promise of driving costs down.”
Looking ahead to 2022, Hunter said insulin will serve as the “ultimate case study” on how managed care stakeholders respond to interchangeable biosimilars, and how payers and PBMs will design plans and formularies.
The ophthalmology space also saw its first biosimilar approval last year, with the FDA green lighting Byooviz, a similar agent to Genentech’s Lucentis for retinal conditions like neovascular (wet) age-related macular degeneration (AMD). The drug is launching this June — however, some ophthalmologists remain hesitant on biosimilars.
Of more than 100 ophthalmologists surveyed by Cardinal Health, only 40% said they considered themselves “very familiar with biosimilars,” and understood how the FDA defines and evaluates the class of medicines. Almost half of the respondents chose the option, “I have little knowledge on the FDA approval pathway for biologics.” And a quarter said they aren’t likely to prescribe a biosimilar to any patient.
When asked what would help them achieve a greater understanding of biosimilars, a vast majority (82%) of ophthalmologists said they’d need more education about safety, efficacy and performance.
Physicians in other areas appear more comfortable with biosimilars, including oncologists, who overwhelmingly said they’d prescribe a biosimilar with an FDA approval based on extrapolation. More than 7 in 10 participating oncologists said they are “very” or “moderately” comfortable with the automatic substitution of biosimilars.
Seventeen of the 21 biosimilars currently on the market are oncology drugs. However, those drugs could soon face a series of hurdles, Cardinal notes. The Oncology Care Model — a five-year project by the Centers for Medicare and Medicaid Innovation that has successfully driven biosimilar adoption — is set to expire this year, with no successor in place.
“The OCM will expire in 2022, and with no replacement VBC reimbursement model yet announced, oncology practices may see a gap for as long as 18 months, which could result in prescribing patterns reverting to prior brand preferences,” Bruce Feinberg, CMO of Cardinal Health specialty solutions, wrote.
Oncology biosimilars may also face competition from second-and third-generation drugs in development.
Then there’s Boehringer Ingelheim’s Humira biosimilar Cyltezo, which was granted interchangeability status this past year. Cyltezo is currently one of seven FDA-approved biosimilars to Humira that are expected to hit the market in 2023.
“It is no coincidence that the number one selling drug in the world, Humira, comes with the most extensive list of biosimilar candidates,” Oskouei said in the report. “With multiple other candidates in development, and various product attributes associated with each one, competition is expected to be fierce.”
While it’s unclear what 2022 will hold in store for biosimilar pricing and coverage, Cardinal says one message is clear: Momentum in this space is accelerating. Analysts say biosimilars are on track to reduce US drug expenditure by $133 billion by 2025.
“2022 is set to be a turning point in the U.S., as biosimilars expand into new therapeutic areas and sites of care, and reimbursement models continue to evolve,” Hunter said.