Biosimilars Conference

The concept of biosimilars is now almost two decades old with extensive experience on their development and use being amassed over that period. During this period analytical methodology for probing structure and comparing biological effects of biological medicines have significantly improved. Yet the regulatory approach to biosimilar approval has hardly changed. This session will explore whether there is still a need for large comparative efficacy and safety trials, and the extent to which comparative pharmacokinetic trials in healthy subjects could together with comprehensive physico-chemical and biological comparative data limit or eliminate the need for large patient studies.

One of the biggest challenges associated with limiting the amount of clinical data needed for approval, this approach is faith that extrapolating structural, in vitro, pharmacokinetic and pharmacodynamic data to determine similarity in therapeutic effect is adequately robust and will not allow products with inferior efficacy -safety profile to be approved for marketing. Still, the current approach of requiring data in one indication and allowing extrapolation to other indications has met with resistance amongst some prescribers and patients. While these concerns are waning – education is a key element in support acceptance and appropriate use of biosimilars and this will be addressed in the second session. Finally, in view of the complexities defining regulatory requirements for biosimilar approval and the need to expand access to these life-changing and sometimes life-saving products – differently regulatory agencies may adopt different approaches to their approval and here WHO has played a key role in supporting regulatory decision making, which is the third presentation of this session.