Members of Life Science Tennessee were in Nashville yesterday for the organization’s annual legislative “Day on the Hill” at the Tennessee General Assembly. A key element of the group’s state policy agenda focuses on “biosimilars”, which is particularly timely in light of Novartis’ Zarxio biologic cancer drug becoming the first biosimilar drug approved by FDA for sale in the U.S. earlier this month.
A biosimilar drug product is a biological product that is approved by the FDA based on a showing that it is highly similar to an already approved biological product (known as a reference product) and has no clinically meaningful differences in terms of safety and effectiveness from the reference product. Until the Affordable Care Act (ACA), there was no approval process for biosimilars in the U.S. until 2010. The ACA created an abbreviated licensure pathway for biological products that are demonstrated to be “biosimilar” to or “interchangeable” with an FDA-licensed biological product.
While biosimilars have been hailed as potentially less costly alternatives to brand-name biologic drugs, their use may be limited by outdated prescribing laws in states like Tennessee. Tennessee’s current generic substitution laws may prevent pharmacists from prescribing a biosimilar in lieu of a biologic drug, even when the FDA has deemed the two medicines interchangeable. Legislation has been proposed, however, that would update state law with respect to biologics and biosimilars, and Life Science Tennessee is advocating for its passage. To date, eight states (DE, FL, IN, MA, ND, OR, UT and VA) have enacted new laws to permit the substitution of interchangeable biological products. Additional states are considering similar legislation this year.
Biological medicines play a growing role in improving health outcomes, although the significant cost of developing and bringing biologics to market are reflected in the price of many of these medicines. As patent protections for brand-name biological products expire, biosimilars stand to play a significant role in reducing treatment costs and improving access to innovative therapies.