Biosimilar uptake in the United States: Examining state-level longitudinal trends in biosimilar filgrastim use and their association with biosimilar substitution policies
Grewal, Simrun Kaur
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Defined as medicines manufactured in a living system, biologics have demonstrated high clinical utility for an array of therapeutic areas. Due to their complex structure and sensitivity to manufacturing processes, it is extremely challenging to develop an exact copy of a biologic—as is possible with small molecule pharmaceuticals. Instead, a similar agent, known as a biosimilar is developed, which demonstrates equivalent effectiveness and safety as the reference brand3. Recognizing the need for increased affordability of promising biologic therapies, many countries have established approval pathways for biosimilars with the aim of reducing the price of biologics through increased market competition. Once a biosimilar is approved by the FDA, individual states can influence the uptake of the products through legislation at the state level. In addition to decentralized policies on biosimilar use, additional factors may impact product use such as disease epidemiology for biosimilar-related indications, varying payer practices on biosimilar coverage and reimbursement. Understanding if and why states differ in their biosimilar use can potentially move us towards optimal uptake, reducing costs and improving patient access to biologics. This quantifies biosimilar filgrastim uptake ratios at the state level, uses longitudinal trends to examine the presence of state sub-groups based on product use, and finally assesses the association between the status and content of state-level biosimilar substitution legislation and biosimilar uptake. While biosimilars hold strong potential to decrease health system costs for powerful biologic therapies, their true cost-savings impact may depend on their uptake throughout the U.S. and this study will provide helpful insight on anticipated uptake trends and the association of policy levers with biosimilar use.