A patient-centred paradigm for the biosimilars market

The advent of similar biological medicinal products or 'biosimilars' in Europe in the 2000s has led to development of a global biosimilars market and regulatory frameworks designed specifically for approval of biosimilars. Like originator biologicals, biosimilars exhibit greater molecular complexity than small-molecule drugs, including generics. Current estimates suggest that biosimilars are more expensive and require longer development times than generics. Regulatory and industry conferences have addressed how to achieve the appropriate level of regulation for biosimilars. Many originator biologicals feature support programmes or additional services that are designed to improve usage by patients, prescribers, and payers; these are not a mandatory part of the regulatory approval process. We refer to these features collectively as the 'biologicals experience' as described and discussed in this paper, and suggest that this experience should be an important element of consideration for the development of public policies on biosimilars.