[Biosimilars, no generic biologicals!].

Abstract

Biologicals are omnipresent in the current therapeutic arsenal for treating several chronic and life-threatening diseases. Following expiry of patent, 'generic' versions of biological medicines are being developed, so-called biosimilars. In view of their potential to reduce the continuous economic pressure of biologicals on the healthcare system, the eagerness to introduce them at fast rate as alternative treatment options is huge. For all parties involved (patients, physicians, pharmacists and other healthcare professionals), it is of utmost importance to get acquainted with the features of biosimilars. Biosimilars differ from generic drugs as they are, as a result of a complex production process in living organisms, never 100% chemically identical to the originator drug. However, the stringent regulatory pathway for approval requires similarity to the reference biological medicine in terms of biological activity, safety and efficacy. Knowledge on immunogenicity, interchangeability and substitution is constantly evolving. As more biosimilars - possibly of the same reference biological - will entrance the market, traceability becomes key for an efficient pharmacovigilance system. Pharmacists, in their role to advice and support patients, should be adequately trained and have access to relevant information about all aspects on biosimilars.