• Physicians have a long experience with switching patients on biological medicines. Regulators have assessed and authorised biologic medicines for 35 years.
  • Physician-led switching is fundamental for unlocking the full potential of biosimilar medicines and is supported by regulators and medical societies throughout Europe.
  • Biosimilar medicines play a key role in increasing access to high quality, biological therapies for patients while helping to lower the drugs bill for patients and the health service.

Medicines for Europe welcomes the fact that EFPIA (supported by EBE and IFPMA) recognises in its recently released paper the well-established nature of physician-led switching for biological medicines. This medical practice is common place, way beyond the sole field of biosimilar medicines.

The three associations also acknowledge that the similarity between a biosimilar medicine and its reference product is so high that if the reference product is associated with loss of efficacy or a tolerability issue, then a switch to the biosimilar medicine would have exactly the same consequences. EU regulators have recently concluded that ‘On the basis of current knowledge, it is unlikely and very difficult to substantiate that two products, comparable on a population level, would have different safety of efficacy in individual patients upon a switch[1]’.

Biosimilar medicines form an essential part of healthcare provision in Europe today. They have brought and will continue bringing competition to the market, providing access to biological therapies which have been out of reach for too many patients in Europe. In an era of tight and pressured healthcare budgets, the benefits of biosimilar medicines cannot be ignored. Physician-led switching is fundamental for unlocking the full potential of biosimilar medicines and is supported by regulators and medical societies throughout Europe.

Regulators have assessed and authorised biologic medicines for 35 years and physicians have a long experience with switching patients on biological medicines. Medical Societies are issuing guidance supporting the introduction of biosimilar medicines[2]. Therefore we believe that the industry should stay strongly aligned behind the robustness of the regulatory science which has proved to be effective following 10 years of experience1.

Adrian van den Hoven, Director General Medicines for Europe, commented: “These are exciting times, new biosimilar medicines in oncology and immunology are around the corner, enabling patient access to key therapies and to support sustainability. This will be at the heart of the debate in our upcoming conference where stakeholders will discuss this opportunity for better healthcare.”

[1] Kurki P, et al. Interchangeability of Biosimilars: A European Perspective. BioDrugs. 2017 Jan 24. doi: 10.1007/s40259-017-0210-0

[2] Overview of position statements – http://www.medicinesforeurope.com/wp-content/uploads/2017/03/M-Biosimilars-Overview-of-positions-on-physician-led-switching.pdf