Originally published by our sister publication Specialty Pharmacy Continuum
By Fran Kritz
Although biosimilars have achieved varied uptake within their first few years on the market, current stakeholder dynamics may ultimately render the medical biosimilar market unsustainable, according to Conrad Bhamani, the manager of the IQVIA Institute for Human Data Science. Mr. Bhamani shared data from several recent company reports in a packed session at the GRx+Biosims 2025 conference, in Bethesda, Maryland.
Mr. Bhamani explained that the Inflation Reduction Act (IRA) of 2022 introduced a new Medicare Cost Report (MCR) policy for qualifying biosimilars—those with an average sales price (ASP) below that of the reference biologic’s (RB’s) ASP—setting payment at ASP plus 8% of the RB’s ASP for five years starting in October 2022. That new payment policy diverged from the traditional ASP plus 6% model based on the biosimilar’s own ASP, and updates a 2018 Medicare (Centers for Medicare & Medicaid Services) policy linking biosimilar MCR to 6% of the RB’s ASP.
“Biosimilar ASPs quickly enter a continual cycle of reductions as their manufacturers compete for access when discounting to payors and providers,” said Mr. Bhamani, adding that “biosimilar ASPs may become financially unsustainable for manufacturers, which could cause market exits and reduce future investments in biosimilars.”
Session panelist Madelaine Feldman, MD, a rheumatologist with The Rheumatology Group, in New Orleans, and the vice president of advocacy and government affairs and immediate past president of the Coalition of State Rheumatology Organizations, said insurance companies are mandating that specialists use certain provider-administered biosimilars whose acquisition cost is higher than what the insurance company is willing to reimburse them.” Essentially, Dr. Feldman said, “the insurance companies expect rheumatologists to pay them to take care of their patients.”
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Shana Christrup, the senior director of policy at the Association for Accessible Medicines, who moderated the panel, told Specialty Pharmacy Continuum that she was intrigued to hear additional details from providers about what they are dealing with, including some biosimilars being unavailable to patients because providers have decided that they can’t continue to lose money on certain infusion drugs. “We’re looking at policy options to take forward, including changes in the ASP calculations or … changing who gets the rebates offered by manufacturers.”
The sources reported no relevant financial disclosures.