Regulation of Biosimilars [2.0 RAC]

Biological products are proteins that are derived from cells or tissues. Biosimilars are biological products that have been demonstrated to have sufficient similarities to a previously approved biological drug, and therefore can gain approval with a reduced clinical and nonclinical data package. Unlike small molecule generics, the complexity of a biologic does not permit the production of an exact copy of the approved product. Not surprisingly then, the biosimilar approval process is more complex and is still evolving, as regulatory agencies and manufacturers work to collaboratively understand the issues arising from biologic products that are similar but not identical.

This first part of the course will examine the sources of complexity in biologics and their production processes. The remainder of the course will provide an overview of the current guidance documents available to address the regulatory approval pathways for biosimilars, and compare the quality, nonclinical and clinical aspects of biosimilar development in three major regulatory jurisdictions, namely the EU, US and Canada.