Biosimilars

Biotechnology has produced medicines for some of the most serious and intractable diseases such as cancer, diabetes and rheumatoid arthritis. Biologics or “large molecules” differ from chemical drugs or “small molecules’’ with respect to their manufacturing processes, size and complexity as well as origin, composition and nature. Unlike small molecules, whose active ingredients are generally chemicals synthesized in a laboratory or extracted from natural sources, biologics are manufactured from genetic material of living cell cultures or DNA technologies.

The manufacturing process for biologics is also more complicated, costly and challenging than for traditional small molecule chemically-based drugs. Because the finished product cannot be fully characterized in the laboratory for most biologics, manufacturers must obtain product consistency, quality and purity by ensuring that the manufacturing process remains substantially the same over time. Variations in manufacturing biologics can result in the production of different proteins, with a different set of clinical characteristics. Biosimilars, also called “follow-on biologics” or “FOBs,” refer to biologics that are marketed after the expiration of patent and regulatory exclusivity for the innovative biologic. A biosimilar is not a generic (i.e., a product approved as an identical copy of an already approved product based on bioequivalence and without any supporting safety or efficacy data) but is a highly similar version of an already‐approved reference biologic product. The regulatory pathways for biosimilars are still evolving around the world with the U.S. and the European Union taking leading roles.

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.