Biosimilars in the United States 2020–2024: Competition, Savings and Sustainability

“This study was produced independently by the IQVIA Institute for Human Data Science as a public service, without industry or government funding.

[..] In 2019, the United States spent $493 billion on medicines at ex-manufacturer invoice prices, including $211 billion on biologics, which now comprise 43% of total medicine spending.

[..] The correlation between the magnitude of molecule sales and the number of biosimilar competitors attracted to the space is not as robust as expected. Rather it appears that the selection of molecules for biosimilar development may be influenced by multiple factors such as technical complexity, intellectual property issues, or expected market size, which could be lower now than was anticipated when biosimilar programs were started.

[..] In the only two examples of PBM-reimbursed drugs, the uptake of insulin glargine and insulin lispro have differed greatly with the former reaching a 23% share of molecule volume and the latter 10%. [..] both insulin products reached 68% uptake in Managed Medicaid by the end of 2019. This is likely due to the incentive structures governing Managed Medicaid, where the outsourced commercial managers retain a share of manufacturer rebates.

[..] The insulin glargine biosimilar launched in December 2016, but was not included on the Medicare Part D formularies until January 2018, reflecting the difficulty of penetrating some insurance pay types. Similarly, in the commercial channel, the biosimilar has only achieved 30% share of volume, though there was early uptake in the channel.

[..] Biosimilar insulin lispro faced an additional obstacle as the originator launched an ‘authorized generic’ with a lower cost than the brand (likely without confidential rebates), which was attractive to some plans where patient price sensitivity was an issue.

[..] Since insulin glargine biosimilar Basaglar launched, costs at invoice prices have declined only 8%, meaning patients have saved less to date from the advent of biosimilar insulins compared with biosimilars for other molecules. [..] The price of the insulin lispro biosimilar, Admelog, is 45% less than its originator, Humalog, and the originator-manufactured ‘authorized generic’ is only 5% more expensive than the biosimilar, bringing two lower-cost options to plans and patients. [..] Medicare and commercial patients save an average of $17 per prescription when using a biosimilar insulin, with Medicare paying on average $18–19 and commercial patients paying $13–14.

[..] The most impactful biosimilars in the next five years — those referencing adalimumab — will first appear in 2023 as a result of negotiated patent litigation settlements. As they reach the market, with five already approved, patients will undoubtedly benefit from lower costs to receive the world’s current top-selling biopharmaceutical.”

IQVIA Institute report, October 2020