The Biologics Price Competition and Innovation Act (BPCI Act) of 2009 provided a regulatory pathway for biosimilar products in the United States. Though savings from biosimilars had been slow to build, recently-launched biosimilars have achieved significant uptake within their first year, and the availability and use of biosimilar medicines is on track to reduce drug costs by $100 billion over the next five years. The development and approvals of biosimilars have been accelerating over the past two years, bringing a total of 33 approvals across 13 molecules to date. Details on biosimilar availability and use are presented in this report, along with scenarios for future biosimilar sales and the systemic savings that they may generate in the future.
This report assesses the current state of the biologics market in the United States and finds that the development and approvals of biosimilars have been accelerating. There have been 33 approvals across 13 molecules to date, though biosimilars for two molecules have not yet launched, and 108 additional biosimilars are in development across 22 other molecules. Savings enabled by the presence of biosimilars are modeled to exceed $100 billion in aggregate over the next five years, though volume and price dynamics remain volatile and significant uncertainty remains.
The current biologics market of $211 billion can be segmented into 19% of the market, or $40 billion, already facing some biosimilar competition, 64% or $135 billion potentially open to biosimilar competition, and an additional 17% of the market, or $36 billion, unlikely to ever face biosimilar competitors. Among recent biosimilar launches, bevacizumab, trastuzumab, and rituximab are set to reach nearly 60% share of volume for their respective molecules by the end of their second year on the market — showing significantly higher and faster uptake than prior biosimilars. This reflects efforts by providers to capture available savings, although their adoption has been highly heterogenous, while patients have benefitted from biosimilars in the form of lower out-of-pocket costs. The introduction of biosimilars in some cases has generated 2–4% incremental demand for the molecule. Finally, the report finds that large pharma companies, often with existing innovative biologic portfolios, have dominated the marketing of biosimilars to date, while smaller companies are developing biosimilars but are more likely to license products to a larger company for marketing.
Biosimilars Reach Inflection Point – On Track to Reduce Drug Costs by $100 Bn Over Next Five Years