Biosimilar medicines prescribing, as per EuropaBio paper, questioned by Medicines for Europe

Some 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; The Pharma Letter April 20).

According to Generic drugs trade group Medicines for Europe and its Biosimilar Medicines Group, this is a major step forward compared to surveys of just two years ago and proves the robustness of the European Union regulatory framework, which now has 10 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.

The trade groups say they took note of the EuropaBio paper on physician preference regarding biosimilar labels (SmPC) 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 authorized 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.