2015 promises to be a big year for biosimilars. Our colleague, Thomas Wintner, recently published an article in Law360 highlighting the biosimilar developments to expect in 2015 and potential areas for future litigation. As the article points out, though the Affordable Care Act created an abbreviated pathway for FDA approval of biosimilars in 2010, no applications for approval were submitted to FDA until 2014.
In addition to issues related to how the FDA will review and approve biosimilars and how intellectual property questions will be litigated and resolved, the approvals of the first biosimilars raise questions about how states will treat biosimilars under their pharmacy laws and how payers will address biosimilar substitution. States already regulate the substitution of generic small molecule drugs for their brand-name counterparts and many states have considered, or have already enacted, legislation addressing the substitution of biosimilars for their reference product counterparts. According to the National Conference of State Legislatures, at least 23 states have considered legislation regarding standards for biosimilar substitution. Some common features of these legislative efforts include permitting prescribers to prohibit substitution, requiring pharmacists to notify prescribers of a substitution, requiring patient consent for substitution, requiring states to create a list of interchangeable products, and requiring pharmacists and prescribers to maintain records of substitution. To date, eight states have passed laws regarding biosimilar substitution (Delaware, Florida, Indiana, Massachusetts, North Dakota, Oregon, Utah, and Virginia). Colorado and New Jersey currently have biosimilar substitution bills pending in their legislatures.