Outlook in 2010

Implicit in criticism of 'follow on' or 'me too' drugs is the idea that their development occurs after a first-in-class drug has made it to market and proved commercially successful. Using analysis of development and patent filing histories of entrants to new drug classes in the past five decades, this article provides new evidence that the development of multiple new drugs in a given class is better characterized as a race, rather than the imitation of successful products.

Fully human monoclonal antibodies (mAbs), which have the potential to be less immunogenic than earlier humanized and chimeric mAbs, are the most rapidly growing class of mAbs in clinical development. Here, Reichert and colleagues highlight trends in the development of human mAbs, seven of which have so far gained regulatory approval.

A lack of entrepreneurial behaviour has often been identified as a contributor to the decline in the research and development (R&D) productivity of the pharmaceutical industry. Douglas and colleagues present an assessment of entrepreneurship in the industry, based on interviews with 26 former and current leaders of R&D departments at pharmaceutical and biotechnology companies, highlighting factors that could be important in promoting entrepreneurial behaviour and revitalizing R&D productivity.

The development of drugs for rare diseases — often known as orphan drugs — is attracting increasing interest and investment, catalysed in part by incentives such as those provided by the 1983 US Orphan Drug Act. This article provides the first comprehensive analysis of 25 years of data on the designation and approval of orphan drugs by the US Food and Drug Administration, with the aim of supporting and encouraging future orphan drug development and approval.

Third-party payers typically base their reimbursement decisions for a new drug predominantly on its health benefits relative to existing treatment options — termed relative efficacy (RE). Over the past decade, the role of payers has become more prominent, and drug developers increasingly need to satisfy the sometimes divergent needs of both regulators and payers to achieve market success. This article describes the political background to the RE debate and the challenges of RE assessment, and discusses the impact of RE on drug development.