On 4 December 2025, the European Commission hosted its ninth multistakeholder event on biosimilar medical products to examine how promotion rules, pricing policies and weak pipelines are shaping biosimilar uptake across Europe. The online meeting drew more than 175 participants and 12 speakers from regulators, payers, industry, patients and researchers.
In opening remarks, Agnès Mathieu‑Mendes, Head of DG SANTE Unit D2, underlined that biosimilars are still not delivering their full savings potential, despite clear opportunities for health systems. She linked the debate to the broader reform of EU pharmaceutical legislation, the Critical Medicines Act and the planned Biotech Act, and highlighted ongoing cooperation through the group of National Competent Authorities on Pricing and Reimbursement and Public Healthcare Payers, as well as EU‑funded projects to support evidence‑based reimbursement decisions.
A patient representative from the European MS platform stressed that biosimilars are not ‘cheap copies’ but clinically equivalent options that can expand timely access to biological therapies. She pointed to persistent misconceptions and anxiety around switching, and called for clear, consistent communication and formal involvement of patients in decision‑making on biologic treatment strategies.
The Organisation for Economic Co‑operation and Development (OECD) presented findings from its Health Working Paper on promotion and advertising rules for biosimilars in seven countries. The analysis found large differences in national rules, oversight structures and responsible authorities, but no consistent link between stricter promotion controls and biosimilar uptake patterns, partly because promotional spending is hard to track and increasingly channelled through indirect routes such as patient organisations and professional groups.
The AUGMENT Biosimilars consortium, funded under EU4Health, reported on a 32‑country mapping of biosimilar policies and market outcomes. It concluded that biosimilars are improving availability of biological therapies and are backed by a growing set of national measures, yet uptake and access still vary widely, and only a coordinated mix of policies and proactive public‑sector action will unlock the full benefits.
IQVIA closed the event with early results from its upcoming biosimilar competition report, focusing on six therapy areas including anti‑TNFs, insulins and ophthalmology. The data suggest that streamlined regulatory pathways that remove routine phase 3 requirements can lower development costs and timelines, but pipeline activity remains weak for low‑sales and orphan biologics, reinforcing concerns about a ‘biosimilar void’ in less profitable segments. Europe remains the largest biosimilar region at nearly 18 billion dollars in list‑price sales, yet major gaps in biologic access persist and may require better forward‑looking planning tools to anticipate the impact of future competition.
Source: European Commission – Summary report, 9th Biosimilar Multistakeholder Event
Link: Summary report – 9th Biosimilar Multistakeholder Event, Brussels (Belgium), 4.12.2025
Date: 4 December 2025
