More news on: Center for Intellectual Property and Entrepreneurship, Prof. Erika Lietzan

Professor Lietzan Cowrites Chapter in FDA in the 21st Century

September 10th, 2015

Erika Lietzan

Professor Erika Lietzan recently cowrote an essay in a book published by Columbia University Press, FDA in the 21st Century, with Professor Henry Grabowski of Duke University.

The book chapter, “FDA Regulation of Biosimilars,” discusses the Biologics Price Competition and Innovation Act (BPCIA), which was enacted in March 2010 as part of the Affordable Care Act (ACA). The objective of the BPCIA, like the Hatch-Waxman Amendments of 1984 for generic copies of non-biological drugs, was to increase price competition and generate cost savings by authorizing approval of follow-on products that rely on pioneer research while at the same time maintaining incentives for innovation.

The essay concludes that obtaining licensure for a biosimilar biological product will require a significantly greater investment of time and resources than are required for approval of generic drugs, and that this – when combined with the fact that biosimilars will not automatically be deemed interchangeable – is likely to mean there will be fewer biosimilar market entrants per biological product than there are generic market entrants per drug. It also means that for the foreseeable future, the biosimilar marketplace is more likely to resemble the brand-to-brand competitive marketplace than the generic drug marketplace.

The chapter also discusses the impact of possible scientific advances, including the ability to demonstrate “fingerprint-like” similarity of biosimilars and their reference products, on cost savings, competition and innovation. It also addresses several key open issues, such as whether and to what extent the Food & Drug Administration will permit extrapolation of effectiveness from one indication to another, the resolution of which could similarly have a profound impact on cost savings, the nature of competition in the market and incentives to innovate.

Professor Lietzan has published and spoken extensively on biosimilars and played a key role in the legislative negotiations that led to the statute’s enactment.

Tags: ,