Biosimilars and innovation: an analysis of the possibility of increased competition in biopharmaceuticals.

The USA is now developing a process for expedited approval of biosimilars. Biopharmaceuticals are far more complex and costly to develop and produce than chemical drugs. Biosimilars raise greater safety issues owing to possible immune responses, are likely to offer smaller percentage price reductions than chemical generics and will probably obtain smaller market shares. Patents may not be as strong for biopharmaceuticals, which are often made by small firms, suggesting the desirability of greater data exclusivity protection. This article suggests that it is better to err on the side of too much protection than too little, given the uncertainties involved.