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, says IQVIA.
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.
Biosimilar Market Development Requires Strategic Flexibility and Global Partnerships
April 29th 2025Thriving in the evolving biosimilar market demands bold collaboration, early global partnerships, and a fresh approach to development strategies to overcome uncertainty and drive future success.
How AI Can Help Address Cost-Related Nonadherence to Biologic, Biosimilar Treatment
March 9th 2025Despite saving billions, biosimilars still account for only a small share of the biologics market—what's standing in the way of broader adoption and how can artificial intelligence (AI) help change that?
BioRationality: EMA Accepts Waiver of Clinical Efficacy Testing of Biosimilars
April 21st 2025Sarfaraz K. Niazi, PhD, shares his latest citizen's petition to the FDA, calling on the agency to waive clinical efficacy testing in response to the European Medicines Agency's (EMA) efforts towards the same goal.
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
How State Substitution Laws Shape Insulin Biosimilar Adoption
April 15th 2025States with fewer restrictions on biosimilar substitution tend to see higher uptake of interchangeable insulin glargine, showing how even small policy details can significantly influence biosimilar adoption and expand access to more affordable insulin.
Latest Biosimilar Deals Signal Growth Across Immunology, Oncology Markets
April 14th 2025During Q1 2025, pharmaceutical companies accelerated biosimilar expansion through strategic acquisitions and partnerships in hopes of boosting patient access to lower-cost treatments in immunology and oncology.