1. Implementation of the Biologics Price Competition and Innovation Act of 2009 https://www.fda.gov/drugs/guidance-compliance-regulatory-information/implementation-biologics-price-competition-and-innovation-act-2009. Accessed May 13, 2020.
2. McCormick N, Wallace ZS, Sacks CA, Hsu J, Choi HK. Decomposition analysis of spending and price trends for biologic antirheumatic drugs in Medicare and Medicaid. Arthritis Rheum. 2020;72:234–41. https://doi.org/10.1002/art.41138. A recent discussion of some of the issues which affect pricing.
3. Schumack GT, Li EC, Wiest MD, Suda KJ, Stubbings J, Matusiak LM, et al. National trends in prescription drug expenditures and projections for 2017. Am J Health Syst Pharm. 2017;74:115–73. https://doi.org/10.2146/ajhp.170164.
4. Considerations in demonstrating interchangeability with a reference product: guidance for industry. https://www.fda.gov/media/124907/download. Accessed May 13, 2020.
5. 45 states have passed biosimilar substitution laws. http://www.gabionline.net/Policies-Legislation/45-US-states-have-passed-biosimilar-substitution-laws. Accessed May 7, 2020.