The working paper highlights that, while biosimilar competition has generated substantial savings in Europe, uptake varies across OECD countries and therapeutic areas. The question of how regulation of promotion influences competition between biosimilars and their reference medicines has received limited attention in the literature. This paper examines the effects of advertising and promotional regulations on biosimilar uptake.

The authors conducted a review of national frameworks and held consultations with 29 key stakeholders in seven countries: Australia, Belgium, Denmark, France, Germany, Italy, and South Korea. Additionally, they carried out an analysis of biosimilar uptake in oncology, rheumatology, and diabetes, focusing on market share and spending to identify links between regulatory stringency and adoption patterns.

The findings indicate that conventional promotional activities—such as direct-to-consumer advertising, detailing, and sponsorships—are generally subject to strict regulation, whereas less conventional activities aimed at patient organisations, healthcare providers, and researchers have less oversight.

The study found no clear association between the stringency of promotional regulation and biosimilar uptake. Instead, broader supply- and demand-side policies related to procurement, pricing, and prescribing appear to have a greater influence. It is likely that originator companies retain significant competitive advantages through financial incentives, proprietary delivery devices, and digital tools.

Overall, the findings indicate that while promotional regulation plays a role, comprehensive policy frameworksare necessary to support the adoption of biosimilars.

Related article
FDA Guidance on Promotional Labelling and Advertising for Biologicals, Biosimilars and Interchangeables

Reference
1. Barrenho, E. et al. (2025), Assessing the impact of promotion and advertising regulations on biosimilar uptake, OECD Health Working Papers, No. 186, OECD Publishing, Paris, https://doi.org/10.1787/c69f54b2-en

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