Clinical trials in the development of biosimilars: future considerations

Abstract:

A number of biosimilars have been approved in highly regulated markets throughout the world. Biosimilar development follows its own unique path – relying primarily on analytics to compare a potential biosimilar to its reference product and giving a reduced, confirmatory role to clinical trials. In addition, the ability to extrapolate data to support approval for indications without a clinical trial gives this abbreviated pathway potential significant value. In fact, so far, all the approved biosimilars in Europe received approval for all the reference product’s indications. However, this is not the case in other regions. Regulatory agencies of the highly regulated markets agree in general on many principles underlying biosimilar product development and approval, but differ in important aspects as reflected by the data burdens and approval decisions for four classes of products explored in this paper – somatropins, filgrastims, epoetins, and infliximabs. These case studies also highlight some biosimilar sponsor latitude as reflected in the varying clinical data packages submitted to the same regulatory agency for biosimilars to the same reference product. There also exists biosimilar sponsor latitude in deciding whether to use the biosimilar pathway at all or seek approval through the stand-alone biologics regulatory pathway. This, of course, is a commercial decision based on the weights each biosimilar sponsor gives to the various risks and benefits for each option, for each product, and for each market. Further, it remains an open question whether a single, biosimilar development plan for global commercialization can be used to satisfy each regulatory agency.

Keywords::

• somatropin
• filgrastim
• epoetin
• infliximab

Disclosure

The author reports no conflicts of interest in this work.