Generic versions of synthetic chemical drugs are now an accepted and important component of the pharmaceutical industry. In
the US, the same is not yet true for follow-on biologics (FOBs). Europe has established a regulatory framework to enable the
approval of what it designates similar biological medicinal products (biosimilars).1 In the US, however, legislative discussions to create such an approval pathway are still ongoing. Meanwhile, in both regions,
patents on innovator products are conspicuously expiring.
Ajaz S. Hussain
We believe that follow-on biologics must become part of the tool kit used to provide effective and affordable solutions to
address patient needs. To make this possible, a regulatory pathway must be established to ensure that rigorous scientific
standards are applied to develop high-quality follow-on products that are as safe and efficacious as their reference originator
products. The road to success for FOB sponsors is not, and should not be, trivial, but nor should it be made impossible for
short-sighted or parochial reasons.
Gillian R. Woollett
This article addresses the history of follow-ons, Europe's regulations, and a future American regulatory framework. We argue
that the competition that will result from an FOB pathway is good, not only for patients, but for the biotechnology industry
as a whole.
LESSONS OF HISTORY AND ECONOMICS
Figure 1. The evolution of biologics. The original biologics were naturally sourced products or synthetic products. As science
progressed, biotechnology made it possible to manufacture recombinant forms of those products. Further scientific progress
has made it possible to develop and approve follow-on biologics (FOBs) that are interchangeable with the innovator products,
and include second generations of innovator products, new formulations, and new indications.
Biotechnology is a means of both research and manufacture. It enabled the creation of the first generation of follow-on biologics—
most of the early biotechnology products were follow-ons to those already made through natural sourcing (Figure 1). The first
biotech product was Eli Lilly's recombinant human insulin, Humulin, approved in 1982.
Figure 2. Scientific progress in biopharmaceuticals continues in the areas of manufacturing technology, analytics, and clinical
studies.
Science and technology have continued to make progress over the last 25 years. Now it is possible to efficiently and cost-effectively
use advanced processes to develop and manufacture subsequent versions of biologic products at high quality, and even at higher
quality, than the original products (Figure 2). As articulated by Mark McClellan while he was FDA Commissioner, it is time
to "accelerate the public health benefits from modern methods to produce more precise, effective medicines and assure their
quality."2,3
