The authors point out that biopharmaceuticals are more complex agents than conventional chemical entities and therefore are more difficult to replicate after patent expiry. Off-patent versions of the originator product, moreover, cannot rely on a simple demonstration of chemical comparability; they are best described as ‘biosimilar’. These differences mean that biosimilar markets will evolve in a more complex way than traditional, small molecule, chemical generics markets.
This Briefing reports the discussions of a group of experts at an OHE workshop on the benefit-risk assessments of drugs. The objective was to identify how particular tools and methods used in economic analysis and the decision sciences might improve the methodologies that regulatory authorities apply to evaluate drug benefit and risk.
For the purposes of defining the economic and policy issues facing the vaccine industry, the comments made here are based largely on the experience in the US, but with some discussion of the global vaccines environment.
Almost every paper in the literature on vaccines starts off with the observation that vaccines are among the most cost-effective of medical interventions, and yet the unfortunate situation (although perhaps not surprising to an economist) is that supply is precarious.
This Briefing discusses, inter alia, the role of the Office of Fair Trading (OFT) in competition cases affecting the pharmaceutical industry. It does so in the context of a discussion of “ex ante” versus “ex post” approaches to regulation. This refers to the balance of reliance in a market on competition, sector specific regulation, and general competition law to deliver efficient outcomes.
One of the main characteristics of the pharmaceutical industry, including biotechnology, is the important role played by public institutions. Their role is not only focused on encouraging research and development (R&D), but also on regulation of the final product market. The special characteristics of the pharmaceutical industry and its economic importance for many nations imply that governments have a strong interest in supporting the efficient functioning of the industry.