药物警戒杂志

抽象的

Pharmacovigilance for Biosimilars

Maria I Karampola and Christos E Emmanouilides

Pharmacovigilance can be defined as the process of collection of safety and to a lesser extent efficacy information regarding pharmaceuticals that have already been launched in the market. It is possible that all toxicity has not been precisely identified before drugs obtain approval for marketing. In addition to relying in ad hoc toxicity reporting, formal studies may be conducted after drug approval to confirm safety (post-authorization safety study, PASS), as well as efficacy (post-authorization efficacy study, PAES). These studies are of paramount importance for biosimilars, due to their macromolecular and potential immunogenic nature. Biosimilars are used in many medical fields, including oncology and rheumatology.

In order to guarantee the success of post-authorization studies, both health care professionals and patients are required to contribute by reporting adverse drug reactions (ADR). The European Union even urges patients to directly report ADR. Apart from physicians, pharmacists play an important role in pharmacovigilance, by keeping accurate records enabling the identification of a specific batch of a biosimilar to be linked to a particular ADR. Thus the principle of non-inter changeability of the prescribed product ought to be followed. PASS are mandatory for biosimilars at the responsibility of the market authorization holder. Implementation of rigorous pharmacovigilance policies will promote physicians' confidence in them, hopefully resulting in financial alleviation of Health Systems.