"Step" versus "phase" in the clinical development of biosimilars: the correct noun holds the key to success

Abstract:

The availability of biosimilars (also known as follow-on biologic or subsequent entry biologic, etc) is expected to improve access to health care and to provide more affordable alternatives to the reference products. However, despite this promise, based on publicly available information from clinical trial databases, there is apparent global disparity in participation (more so in oncology) and interest in the clinical development of proposed biosimilars. The disparity seems to be partly due to lack of access to biologics, as well as expectations of the development process and/or study objectives. There is inherent misalignment between the characterizations of the clinical studies, in the public domain, with regulatory guidance (eg, the use of “Phase” to describe a comparative study). There is also apparent non-appreciation of potential research opportunities afforded by the biosimilar development paradigm. It is imperative that key stakeholders required for the development of this class of drugs are adequately engaged and that they fully understand the development paradigm, if the promises of biosimilars are to be realized globally.

Keywords::

• p-biosims
• follow-on biologic
• biologics
• regulatory guidelines
• clinical studies

Disclosure

The author reports no conflicts of interest in this work.