Biological medicines have become indispensable in the treatment of patients with serious diseases such as cancer and inflammatory diseases. Biosimilars are medicines which are developed to be similar to existing biological medicines (the 'reference product'). For the European market, they are approved by the European Medicines Agency.
Due to the rising importance of biosimilar medicines, EAHP decided to set out the position of the Association on key issues concerning biosimilar medicines including the role of hospital pharmacists regarding the uptake of biosimilars in healthcare in terms of selection, procurement, logistics, information, education and collecting real life experience (e.g. in monitoring and pharmacovigilance) in a position paper.
This position paper addresses, in addition to the role of the hospital pharmacist, EAHPs view on
- naming of biosimilar medicines;
- extrapolation of indications; and,
- information about biosimilar medicines.
The key positions of EAHP on the above topics are summarised on the first page of the position paper. Each position does however not stand by itself and thus should be read in conjunction with the corresponding supportive information presented in the position paper.
This holds also true for EAHPs view on interchangeability, switching and substitution of biosimilar medicines which is based on the evidence mentioned in the position paper. 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. Nevertheless, due to patient specific issues there are instances where it is not appropriate to make a switch. It should therefore be ensured that the considerations of the prescriber, the pharmacist and the patient whether to choose the reference product or its biosimilar are taken into account. Provided that the above safeguards are in place, EAHP supports substitution at hospital pharmacy level. In both instances, it is acknowledged by EAHP that decisions regarding switching and substitution may be taken on either national or local level.
EAHP's position paper on biosimilar medicines is available HERE
As announced in the EU Monitor of 10 May 2017, the European Commission and the European Medicines Agency jointly prepared an Information guide for Healthcare Professionals on Biosimilars in the EU. The objective of the guide is to provide healthcare professionals with reference information on both the science and regulation underpinning the use of biosimilars.