Sustainable biosimilar competition in Europe: can it be achieved?

According to The Biosimilar Medicines Group, part of Medicines for Europe, a new report by IQVIA indicates there is a window of opportunity for the EU to foster future-proof biosimilar competition.

This publication has come in wake of the EU actively reviewing its Pharmaceutical Legislation. Julie Marechal-Jamil, Director Biosimilar Policy & Science at Medicines for Europe stated the report identified “many policy shortcomings that must be addressed now to deliver access to medicines in the future”.

IQVIA’s report reflected on the growing biological medicines market and the opportunity to improve equitable access in relation to competition for these medicines. Its analysis provides recommendations for supporting development of biosimilars and competition up to 2032 by the European Institutions, the European Medicines Agency (EMA), the Heads of Medicines Agencies (HMA), and EU Member States.

Failure to attract biosimilar competition

The report emphasised that there is a “huge” biosimilar void to 2032, the group shared. This year was selected as an assessment cut off to “reflect the average development timeline for new candidates (~7-10 years) and intrinsic limitations with forecasting data beyond 2032”, IQVIA stated in its report summary.

In its response to the report, Medicines for Europe’s sector group for this category of medicines highlighted statistics which cautioned: “€15 billion worth of biological medicines losing exclusivity has no visible competition with biosimilars. This represents nearly 25 percent of the total opportunity.”

The group also drew attention to report’s identification of key regulatory and market policy reforms that could stimulate investment in biosimilar development and smarter use of these medicines.

Another key area discussed in the report, was that to stimulate development of these medicines, enhancing regulatory efficiency at EU level must be enhanced, “by way of regulatory streamlining in line with science and experience and, through a more dynamic approach to removing access barriers (eg, reimbursement) at biosimilar entry.”

Marechal-Jamil added: “So far, biosimilar medicines have delivered huge access benefits for patients and savings for healthcare budgets… We need to jump start the multistakeholder policy process ensuring more biosimilar medicines development and access, as patient demand for biological medicines increases.”

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