Biosimilar Oncology Drugs in Europe: Regulatory and Pharmacovigilance Considerations.

Abstract

The introduction in clinical practice of pharmaceutical products known as biosimilars, as part of a more complex series of progress in the field of biological drugs, represents an excellent therapeutic resource. A biosimilar drug is a biological/biotechnological drug that is highly similar to an approved reference biologic product. Given their complexity, biosimilars require attention and a continued vigilance to ensure appropriate use, especially in cancer therapy. There is the urgent need, both at Italian and European levels, of clear and more comprehensive guidelines to elucidate the open questions. Probably, the acquisition of new data, obtained from larger samples of patients than those used in the pre-approval studies and with extremely variable clinical conditions, will allow clarifying the extent to which biosimilar drugs are similar in safety and efficacy to their biologic reference drug. The aims of this article are to provide health professionals with basic, but essential information about biosimilars, and to identify current critical points and future perspectives for clinical practice, cancer care, regulatory aspects, and pharmacovigilance.