88,6% of doctors know what biosimilar medicines are and 59% have already prescribed biosimilar medicines as a high quality treatment for their patients, according to EuropaBio paper on physician preference regarding biosimilar labels (SmPC)[1]. This is a major step forward compared to surveys of just two years ago and proves the robustness of the EU regulatory framework, which now has ten years of positive experience in approving these safe, high quality and efficacious biosimilar medicines. The first part of the study clearly demonstrates the increased trust and acceptance by the medical community of biologics, including biosimilar medicines, according to the survey.

Medicines for Europe and its Biosimilar Medicines Group took note of the EuropaBio paper on physician preference regarding biosimilar labels (SmPC)[2] which attempts to create an unnecessary differentiation between biosimilar medicines and their reference products, despite the stringent science-based EU approval process guaranteeing full comparability in efficacy and safety. Biosimilar medicines are assessed and authorised based on a head-to head comparison and the ‘totality of evidence’ available, which includes the experience and knowledge gathered for the originator medicine and well captured in the ‘same label’ approach, which is consistent with the EU legal, scientific and regulatory framework, as well as the current practice for all medicines in case of a line extension or following manufacturing changes.

Regrettably, the second part of the paper fails to acknowledge some fundamental elements such as the existing consensus on the need to improve accessibility and suitability of the information on all medicines for both Healthcare Professionals and Patient Communities, beyond the sole product information. The availability of unbiased information from regulatory agencies is typically not an issue thanks to transparent policies where, for example, anyone can access the European Public Assessment Report for any centrally authorised medicine on the EMA website.

According to Adrian van den Hoven, Director General Medicines for Europe, “our Biosimilar Medicines Group is engaged in many multi-stakeholder platforms to facilitate the accessibility and understanding of the information”.

See the Annex document with the full position

[1] Physicians prefer greater detail in the biosimilar label (SmPC) – Results of a survey across seven European countries, A.Hallersten et. al, http://www.sciencedirect.com/science/article/pii/S0273230016300654

[2] Physicians prefer greater detail in the biosimilar label (SmPC) – Results of a survey across seven European countries, A.Hallersten et. al, http://www.sciencedirect.com/science/article/pii/S0273230016300654

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