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EU must bolster biosimilar medicines policy to increase equity of access and bring much needed savings to healthcare budgets


25 May 2023


Health & Consumers

Date of release: 25 May 2023

The benefits of biosimilar medicines are clear. They bring cost effective medicines to health systems, clinical options to patients and their use dramatically increases access to medicines across Europe.

To deliver on these benefits, the EU must take action to address the growing disparity in patient access across the continent for auto-immune conditions (rheumatoid arthritis, inflammatory bowel disease, psoriasis) with a 114% gap, cancer (50%) or diabetes (20%)*.  

The Biosimilar medicines group is committed to making life changing biological therapies available to more patients and, together with stakeholders, to shape the necessary policy environment to achieve this.  The road to biosimilar competition is clear and entails:

  • creating an efficient EU regulatory system for biosimilar medicines by adapting to state-of-the-art biological regulatory science and streamlining requirements, notably in the field of clinical comparability.
  • allowing timely access to biosimilar medicines at loss of exclusivity by reforming procurement mechanisms and incentivising biosimilar use.
  • ensuring a competitive market with multiple suppliers and removing unfair clawback taxes which penalise the only industry that delivers savings to healthcare.

Commenting ahead of the Biosimilar medicines conference, BIOS23, Julie Maréchal-Jamil, Director Biosimilar Policy & Science at Medicines for Europe said: “Our vision for availability, accessibility and affordability of biological therapies is aligned with the EU pharmaceutical policy reform to deliver access, availability and affordability. But there is a major challenge since data shows that 50% of the biological medicines going off patent will probably not see competition from a biosimilar medicine. We owe it to patients and for healthcare sustainability to correct the inadequacies of the current policy framework and to make biosimilar medicines an integral part of the EU reform roadmap.

Resource hub

Policy experts will discuss the future of biosimilar medicines at the Biosimilar medicines group Conference BIOS23 in Amsterdam on May 25-26. For more information about the event, see

*The data quoted in this press release can be found at IQVIA Impact of Biosimilar Competition in Europe 2022

The Biosimilar medicines group

The Biosimilar Medicines Group is a sector group of Medicines for Europe representing the leading companies developing, manufacturing and/or marketing biosimilar medicines across Europe. With more than 15 years of positive patient treatment experience, biosimilar medicines today provide a huge opportunity to deliver significantly improved access to modern therapies for millions of European patients in both chronic and acute care. Our members bring competition to the biological medicines market, thereby increasing access to highly innovative treatments to patients in Europe and around the world, and supporting the sustainability of the European healthcare systems.

About Medicines for Europe

Medicines for Europe represents the generic, biosimilar and value added medicines industries across Europe. Its vision is to provide sustainable access to high quality medicines, based on 5 important pillars: patients, quality, value, sustainability and partnership. Its members directly employ 190,000 people at over 400 manufacturing and 126 R&D sites in Europe, and invest up to 17% of their turnover in R&D investment. Medicines for Europe member companies across Europe are both increasing access to medicines and driving improved health outcomes. They play a key role in creating sustainable European healthcare systems by continuing to provide high quality, effective generic medicines, whilst also innovating to create new biosimilar medicines and bringing to market value added medicines, which deliver better health outcomes, greater efficiency and/or improved safety in the hospital setting for patients. For more information please follow us at and on Twitter @medicinesforEU.

Medicines for Europe press contact:

Kate O Regan


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