Economic Considerations Related to Biosimilar Market Entry
American Bar Association Antitrust Law Section, 2024
As the number of biologic and biosimilar products approved by the US Food and Drug Administration (FDA) has grown, antitrust and competition-based litigation involving these products has increased and could intensify in the coming years. Relatedly, the FDA released draft guidelines in June 2024 to address the interchangeability of biologics and biosimilars. While the FDA’s guidelines may provide a helpful backdrop to understand the comparative effectiveness of biosimilars and biologics, they leave open certain questions that may arise in litigation venues, including with respect to class certification, liability, and damages.
To examine those questions, Analysis Group Managing Principals Pavel Darling and Andrée-Anne Fournier and Vice President Michael Carson studied uptake and pricing trends following the introduction of biosimilars and how competitive environments have evolved for different biosimilar entrants. In an article describing their research, the authors examine what competitive dynamics might be at play, how rapid uptake is for biosimilar entrants, and what could happen when antitrust litigation related to these issues occurs. The authors conclude that “the uptake and price experience of currently available biologics and biosimilars is varied and not uniform” and suggest that assumptions and factors relied on in antitrust and competition matters involving biologics and biosimilars should be tailored to the specific products at issue in each case.
The article, “Economic Considerations Related to Biosimilar Market Entry,” was published by the American Bar Association Antitrust Law Section.