IFPMA Policy Position on Non-Comparable Biotherapeutic Products

Position paper 15 Feb 2023

Pharmacy-mediated substitution for biosimilars

This position paper from IFPMA addresses substitution relating to biosimilars and their reference products at the retail pharmacy level. While this practice has been in place in many countries for generics, for biosimilars, the practice is only emerging.

Synthetic follow-on products that reference biologically produced medicines

The focus of this paper is follow-on versions of smaller protein products developed to be marketed following expiry of patent and data protection of the reference product. They are synthetically produced while the reference product is manufactured recombinantly.