Global position statement on biosimilars

BMS supports the development and use of biosimilars approved by regulatory authorities and commercialized only when intellectual property protections have expired or are no longer enforced by the innovator, and when incentives for future biologic innovation are preserved. Where strong intellectual property and safety standards are upheld, BMS believes that biosimilars can increase off-patent competition, therefore increasing the availability of affordable medicines, improving patient adherence, helping contain healthcare costs, and providing a channel to expand patient access to important medicines.

BMS believes that patient safety should be prioritized. Biosimilars should therefore not be automatically substituted for a reference biologic medicine unless and until pertinent interchangeability criteria are in place that address patient safety and efficacy.

BMS opposes therapeutic reference pricing, including for innovator products and biosimilars, to which an average reference price is applied. Innovation is an incremental process—improvements in patient care and outcomes are a result of cumulative incremental advances that occur over many years. Meanwhile, therapeutic reference pricing's blanket categorization of products overlooks post-approval advances in innovation. BMS believes that pro-innovation policies are entirely consistent with support for access to quality and affordable biosimilars in the future. Today’s innovative medicines will be tomorrow’s biosimilars.