The US Biosimilars Market: A History of Growth and Towards a Sustainable Future

Access Market Intelligence’s colleague, Stanton Mehr, President of SM Health Communications, Inc., has published the updated 2023 edition of the BR&R Report, The US Biosimilars Market: A History of Growth and Towards a Sustainable Future continues a tradition of being a vital, independent resource for those managing biosimilar and biopharmaceutical assets.

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So much changes from year to year in the biosimilar marketplace, and we recognize the value only the latest information will provide. The highly sought 2021 edition listed 29 biosimilars approved in the US for 9 reference products (but a significant number are as yet unmarketed).

As of early January 2023, this number is up to 40 approved for 11 reference products), and the number of marketed biosimilars will be improved significantly this year with the launch of several adalimumab biosimilars. The first two interchangeable biosimilars have officially been designated by the FDA, and much has happened outside of drug approvals that has affected biosimilar policy, pipeline, and payer decision making.

The US Supreme Court has ruled on the validity of the ACA and as a result, the BPCIA. Payers have devised their strategies for the huge adalimumab launches this month and later this year. And future biosimilar interest in specific biologic reference products is coalescing around revenue expectations, perceived opportunity, and a better sense of who will continue to play in this market space.

The 2023 edition updates the biosimilar story–past, present, and future–of the industry in the US. Readers of The US Biosimilars Market: A History of Growth and Towards a Sustainable Future will gain comprehensive business and market access picture of the biosimilar industry, its economics, and its pipeline.

New for 2023:

• An expansive description of the biosimilar pipeline, with commentary on each of the most significant drug categories
• The primacy of payers as the dominating force in biosimilar coverage, access and utilization, and success
• A practical discussion of the value of interchangeability in biosimilars and how it helps and hinders the economic decision making for payers and manufacturers
• Factors that are improving the environment for biosimilars and threats, such as unintended consequences of the Inflation Reduction Act, which could potential stifle innovation in biosimilar development
• A heavily updated Marketplace Insights section, to reflect the latest developments and trends