US Biosimilar Activity Will Start in Earnest in 2023, Report Says

By 2023, the segment of the biologics market in the United States that faces competition from biosimilars will have grown 3 times larger than in 2019, resulting in nearly 10% cumulative savings.

Those numbers come from a new report from IQVIA that provides an outlook on the global use of medicine through 2023. According to the report, while the bulk of biosimilar activity has historically taken place outside of the United States, the 2023 entrance of biosimilar challengers to brand-name adalimumab, Humira, will see biosimilar activity pick up substantially in the US market.

IQVIA also predicts that although the United States will see the long-awaited launches of FDA-approved biosimilar trastuzumab and bevacizumab products later this year, biosimilar activity will likely experience a lull in the United States between 2019 and 2023, as fewer losses of exclusivity—and therefore fewer market entries—are expected.

Even with such a slowdown, according to the report, US spending on biologics in 2019 will be approximately $7 billion lower than it would be if no new biosimilars had entered the market after 2017, and that savings is expected to grow to $18 billion by 2020 and $27 billion by 2021.

Notably, however, IQVIA’s analysis relies on the inclusion of follow-on somatropin and follow-on insulin glargine as biosimilars, although no hormones or insulins are currently regulated as biologics in the United States and follow-on products do not follow the biosimilar approval pathway and are not subject to policies addressing biosimilars. The report also omits mention of biosimilar epoetin alfa, which launched in the United States in 2018.

The savings generated from biosimilars could create welcome headroom for growing spending on specialty drugs in the US market, where specialty drugs’ share of total medicine spending will approach 50% by 2023. Growth in this area will be driven, says IQVIA, by oncology, autoimmune, immunology, HIV, and multiple sclerosis products.

High-cost cell, gene, and regenerative therapies are also in the pipeline, and the report predicts that 5 to 8 such products will be approved in the coming 5 years. While these products are expected to produce substantial clinical benefits for patients, high list prices, small patient populations, and the fact that some therapies will offer full therapeutic impact after a single treatment will pose unique challenges for payers that will require innovative approaches to funding.