Camouflaging State Biosimilar Laws as Pro-Patient Legislation

Abstract

Biologics, the most effective medications used to treat chronic debilitating autoimmune diseases such as Rheumatoid Arthritis, are also the most expensive, even for those with top shelf insurance. Biosimilars, which replicate biologics through the use of similar living organism extracts, will impact biologics’ American sales — biosimilars are generally much cheaper than biologics. Legal scrutiny in the biologic/biosimilar arena has focused on the Amgen versus Sandoz litigation, market share, and the biosimilar FDA approval process, established through the Biologic Price Competition and Innovation Act. Less coverage has been devoted to state-level battles over biosimilars. States have considered how biosimilars should be named, even though there is FDA guidance on the issue. Many state laws impose patient and physician consent requirements on insurance companies or pharmacists that seek to substitute biosimilars for biologics, even though the FDA does not require any additional action once an interchangeable biosimilar is exchanged for a biologic. This essay will consider whether state laws are impeding biosimilar market access, addressing how the laws have been marketed as “patient-friendly” legislation. Finally, it will propose how to involve patients at the state legislative level so that patient needs are heard and met.

Keywords: Patent, Biologics, Biosimilars, Testimony, Stakeholders, Health Law, Patients, FDA

JEL Classification: I14, I18, I11