Nancy Globus, PharmD, on Whether Comparative Efficacy Trials are Necessary

There has been much debate recently whether comparative clinical efficacy trials are really necessary for demonstrating that a biosimilar candidate is equivalent to a reference product. Many argue that they contribute little to the weight of evidence available from other testing required by regulatory authorities, such as the FDA and the European Medicines Agency. A recent study of costs of these trials showed that they actually may end up costing more to do than the pivotal trials that led to the approvals of originator drugs.

We sat down with Nancy J. Globus, PharmD, vice president of Regulatory Affairs at the Accreditation Council for Medical Affairs, for her take on these requirements and whether they add meaningful data for the purposes of biosimilar acceptance.