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.
Bristol Myers Squibb’s Position and Key Messages
Bristol Myers Squibb supports the establishment of a regulatory pathway for the approval of biosimilars that is driven by the best available science, considers efficacy and patient safety and preserves incentives for future biologic innovation. We believe that biosimilars should not be automatically substituted for a referenced biologic medicine without consultation with the prescribing physician. Unlike generic small molecule drugs, biosimilars are highly similar to the original medicine but not equivalent, therefore, the traditional generic drug pathway process is not appropriate for the development, regulatory assessment, licensing, prescribing and dispensing of such a biosimilar product. Prescribing should be by brand name giving physicians the necessary freedom to choose the most clinically appropriate products for their patients.
The development and manufacture of biologics is time-consuming, costly and bears considerable risk. Biopharmaceutical companies invest an average of $1.5 billion over 15 years to bring a biologic from discovery to regulatory review and eventual market approval.1 2 It is vitally important to provide incentives and the appropriate support to such valuable innovation in terms of patents, trade secrets and data exclusivity. Bristol Myers Squibb supports the current U.S. 12-year biologic data exclusivity period.
1 Joseph DiMasi and Henry Grabowski, “The Cost of Biopharmaceutical R&D; Is Biotech different?”, Managerial and Decision Economics, Volume 28, Issue 4-5, pp. 469-479, August, 2007
2 Henry Grabowski, Genia Long & Richard Mortimer, “Data Exclusivity for Biologics”: Nature Reviews Drug Discovery, 10, 15-16, January 2011.