Challenges with the Introduction of Biosimilars in the US

With the introduction of biosimilars in the United States, there are several significant areas that will be challenges to those involved in formulary committees and benefit plans, as well as prescribers and pharmacists. These include: Extrapolation of indications: benefit plans and formulary committees will need to determine the placement of biosimilars on formularies based on indications and criteria for use. Given the abbreviated approval pathway, the extrapolation of indications will be a significant area of consideration. Selection of reliable manufacturers: given the potential risks of immunogenicity associated with switching biological products, it will be important to select biosimilars manufactured by companies with a good track record of supply reliability and with demonstrated expertise in biologic manufacturing. Interchangeability/substitution: data and policies/regulations on product substitution and therapeutic interchanges are evolving, and will need to be considered based on practice standards, as well as state laws. Challenges with naming: the currently proposed approach to biosimilar naming has the potential to create some unintended consequences. Understanding these challenges will allow the development of strategies to prevent inadvertent switching and improve consistency in therapy. Benefit plans, formulary committees, prescribers, and pharmacists will all need to be aware of these challenges in order to assure the safest and most appropriate use of biosimilars in the US health system.