Biosimilar Confusion and Insights

Today's Insight from AMI
Dr. Randy Vogenberg

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.

This issue continues to pit manufacturer versus 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. However, biosimilar drugs can be manufactured once patents expire for the existing brand-name biologic drugs, raising regulatory issues in the states.

The FDA has developed lists that are designed to help enable a user to see whether a particular biological product has been determined by the organization to be biosimilar to or interchangeable with a reference biological product. Late last year the FDA released their first biologic “Purple Book”, akin to the Orange Book, but did not provide any clarity or new pathway on product approval for interchange.

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 U.S. that include formulary decision-makers, healthcare administrators, third party benefit administrators, and purchasers of care who set benefit design parameters.