Since Virginia became the first state in May 2013 to enact legislation regulating a pharmacist’s substitution of an interchangeable biologic drug for a prescribed reference biologic drug, there has not been much activity or clarity on the issue.
VogenbergSince Virginia became the first state in May 2013 to enact legislation regulating a pharmacist’s substitution of an interchangeable biologic drug for a prescribed reference biologic drug, there has not been much activity or clarity on the issue.
This issue continues to pit manufacturer against manufacturer, and other stakeholders against each other in the policy arena, resulting in a legal or regulatory mess for practitioners, patients, and purchasers. Renewed activity on the regulation of biologics has again raised issues for both state and federal policy makers while leading to continuing confusion among healthcare practice or administrative stakeholders with a responsibility for patient care.
Biologics, due to their complexity, are much more difficult to reproduce than generics for other drugs, making exact identical “generic” versions next to impossible to produce. Biosimilar drugs, however, can be manufactured once patents expire for the existing brand-name biologic drugs, raising regulatory issues in the states.
FDA has developed lists that are designed to help enable a user to see whether a particular biologic product has been determined by the organization to be biosimilar to or interchangeable with a reference biologic product. Late last year, FDA released their first biologics “Purple Book,” akin to the Orange Book, but did not provide any clarity or new pathway on product approval for interchange.1
Leaving the decision, to date, up to the states has raised concern that their traditional regulations on generic drugs may be misused when applied to new biologic products that are not identical. As a result, some states have started to amend older state laws to address the characteristics of biologics, as well as any future biosimilars.
Access Market Intelligence monitors this issue and has found that at least 23 states have considered legislation establishing state standards for substitution of a “biosimilar” prescription product to replace an original biologic product. This raises further questions on healthcare stakeholders across the United States, which include formulary decision makers, healthcare administrators, third-party benefit administrators, and purchasers of care who set benefit design parameters.
1. FDA. Purple Book: Lists of licensed biological products with reference product exclusivity and biosimilarity or interchangeability evaluations. Updated December 22, 2014. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/ucm411418.htm. Accessed January 20, 2015.
Dr Vogenberg is cofounder of Access Market Intelligence and HBI Institute. He is principal of the Institute for Integrated Healthcare. He can be reached at firstname.lastname@example.org