In July 2021, the U.S. Food and Drug Administration granted a determination of interchangeability to a biosimilar drug for the first time.
This approval has raised expectations for the potential of biosimilars to lower the costs of biologic drugs as it is expected to be permitted to be substituted for the reference product at the pharmacy.
Collectively, sales of biologics, including biosimilars, have grown substantially in the past several years.
As of 2018, biologics accounted for 36% of all prescription drug spending in the U.S. As the U.S. biologics marketplace continues to evolve, it will be important for both branded biologic manufacturers and biosimilar manufacturers to understand the changing dynamics of the market and how those dynamics may impact biosimilar litigation.
One critical consideration is the possibility that originator biologics may experience price erosion due to biosimilar entry as this can have a significant impact on issues such as launch-at-risk decisions, potential damages, settlement evaluation and the assessment of irreparable harm.