ABSTRACT
The pressure to make biologics more widely accessible has resulted in the emergence of laws in Europe, the United States, Japan, India, Canada, Australia, and a handful of other countries aimed at creating pathways for the approval of follow-on versions of existing biological products. This chapter discusses these laws and the “track record” of the regulatory pathways that they have created, highlighting prominent features of these regimes. It provides a short review of biologics- and biosimilars-specific sections in international trade agreements and some recommendations for countries seeking to create their own regulatory pathways for the approval of biologics and follow-on versions thereof. In Australia, new biologics are evaluated and approved by the Therapeutics Goods Administration in the Department of Health based on their quality, safety, and efficacy. As the significance of biologics and their proportion among pharmaceuticals available to treat patients increases, it also becomes more important to create and streamline regulatory pathways for the approval of biologics and biosimilars.
