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In June, the European Association of Hospital Pharmacists (EAHP) published its position paper on biosimilar medicines outlining the Association’s views on the role of the hospital pharmacist, naming of biosimilar medicines, extrapolation of indications, information about biosimilar medicines as well as interchangeability, switching and substitution of biosimilar medicines.
Biological medicines have become indispensable in the treatment of patients with serious diseases such as cancer and inflammatory diseases. An increasing number of biological medicines are biosimilar medicines. These are developed to be similar to already existing biological medicines. The European Medicines Agency (EMA) is the body responsible for their approval in the European Union.
The position paper of EAHP closely follows the line of EMA on matters concerning naming of biosimilar medicines and extrapolation of indications. The evidence acquired over 10 years of clinical experience has shown that biosimilar medicines approved through EMA can be used as safely and effectively in all their approved indications as other biological medicines. Thus, EAHP has expressed confidence in EMAs regulatory pathway for biological reference products and biosimilar medicines.
Hospital pharmacists are stewards of appropriate selection, procurement, logistics and use of medicines as well as key players in pharmacovigilance. Consequently, they are uniquely positioned and capable to promote the appropriate utilisation of biosimilar medicines. Their knowledge is therefore particularly relevant with regard to switching and providing the evidence on patient safety and treatment quality.
In terms of interchangeability, switching and substitution of biosimilar medicines, EAHP supports the view that a reference product and its biosimilar(s) are interchangeable and therefore can be switched. EAHP holds the same view for biosimilars to the same reference product. These views are based on evidence presented in the position paper. Nevertheless, due to patient-specific issues, EAHP acknowledges that there are instances where it is not appropriate to make a switch. …
Competing interests None declared.
Provenance and peer review Commissioned; internally peer reviewed.