Cardinal Health Report Sees 2022 as “Turning Point” for Biosimilars

Use of biosimilars will reach new therapeutic areas and new sites of care in 2022, as the industry prepares for competition with Humira, the top-selling drug in the world—an event that will mark a seismic shift not only in the pharmaceutical marketplace but across health care, according to a new report from Cardinal Health.

The year 2022 “is set to be a turning point,” in the United States, as biosimilars are on their way to delivering $133 billion in aggregate savings by 2025, according to, “2022 Biosimilars Report: The U.S. Journey and Path Ahead.”

“Total savings to patient out-of-pocket costs based on just the current biologics with biosimilars approved are estimated to reach up to $238 million,” predicted Heidi Hunter, president, Cardinal Health Specialty Solutions, in the report’s final section, which offered a forecast for 2022 and beyond.

Cardinal Health’s overview offered a primer on the landscape since the first supportive care biosimilars came on the scene in 2015, noting that specialists in oncology and, to a lesser degree, rheumatology have gained experience using these products; provider survey data contained in the report reflects this increased familiarity.

Biosimilars have already shaped the market, especially where payment models have encouraged their use. This is especially so in cancer care, where the Oncology Care Model in Medicare has rewarded participating practices for taking advantage of savings from biosimilars.

“Significant progress has been made in the adoption of biosimilars in the U.S., particularly in oncology, where all 3 classes of therapeutic oncology biosimilars (i.e., rituximab, bevacizumab, and trastuzumab) have exceeded 60% market share,” the report states. “Savings from biosimilars increased to approximately $8 billion in 2020 alone, more than tripling savings derived from previous years. In addition, for the first time in 7 years, oncology expenditure growth fell below 10% due to the impact of biosimilars and new product launches.”

Now, the report says, the field is poised to fulfill is promise of offering greater choice and holding down health care costs for more groups of patients, as biosimilar insulin and new products in ophthalmology reach the market. Hunter predicted these 5 trends for 2022:

• Insulin will offer a test for interchangeable biosimilars. The year 2021 was light on approvals but Semglee, the interchangeable biosimilar for Lantus, packed a whallop. Semglee (insulin glargine-yfgn), which has an FDA designation that allows pharmacist substitution without prescriber approval, will show how payers, pharmacy benefit managers (PBMs), and retail pharmacists will react to this FDA designation.
• Manufacturers will protect their turf. As Humira (adalimumab) faces competition from up to 7 biosimilars next year, other rheumatology and immunology drugs are bracing for the fallout.
• Uptake in eye care will be slow. Retinal care will get most of the attention, as the number of patients with wet age-related macular degeneration rises and the cost per treatment remains $2000 on average. Byooviz (ranibizumab-nuna), the first biosimilar ophthalmology, was approved in September 2021 and appears likely to launch in June 2022.
• Policy will be on biosimilars’ side. The Biden administration order for biosimilar approval transparency along with market transparency will help the cause. Rulemaking from FDA and actions by the Federal Trade Commission will support competition, and so will a new approach to payment models that promote biosimilar use in Medicare.
• Use of real-world evidence will increase. This will provide particular insight into the effects of switching therapies.

While Cardinal’s report states that the best is yet to come for biosimilars, it doesn’t paint a bleak picture for these products. In fact, its provider survey finds that among those who are well-acquainted with biosimilars, comfort has never been higher with using the therapies—even switching patients to biosimilars during curative treatment. Among the findings of the provider survey:

• Among the 4 categories of specialists surveyed—oncologists (N = 323), rheumatologists (N = 102), ophthalmologists (N = 102), and diabetes care specialists (N = 54)—only the ophthalmologists reported less than half (40%) being “very familiar” with biosimilars. Except for the ophthalmologists, more than 90% of the specialists were “very familiar” or “somewhat familiar” with the products.
• 67% of oncologists said they would prescribe biosimilars to a patient having success on a reference product regardless of payer considerations, while rheumatologists (35%) and diabetes care specialists (72%) were more likely to prescribe to existing patients if this was required by a payer or PBM.
• More than 7 of 10 oncologists said they were “very” or “moderately” comfortable with automatic substitution of biosimilars, and only 5% said they would not subscribe biosimilars for indications without clinical trial data.
• More than 90% of oncologists said they are comfortable with switching between biosimilars at least in some cases.

Cost savings to both patients and a practice are considerations for providers, although its degree of importance may vary. However, two-thirds of rheumatologists say that the economics of prescribing remain a barrier to biosimilar adoption.

The report describes “momentum” around bringing biosimilars to market as strong, and that the trend to move beyond oncology and rheumatology will define the next 5 years. 

“The year ahead is sure to include many significant biosimilar milestones,” the report states.