By Rachel Sachs
Yesterday, I had the privilege to moderate a fantastic event here at the Petrie-Flom Center on Assessing the Viability of FDA’s Biosimilars Pathway. Bringing together expert panelists from legal practice (Donald R. Ware, Partner, Foley Hoag LLP), industry (Konstantinos Andrikopoulos, Lead IP Counsel, Manufacturing, Biogen, Inc.), and academia (W. Nicholson Price II, Assistant Professor of Law, University of New Hampshire School of Law), the event explored different aspects of the biosimilars issue, considering the guidances issued (and still to be issued) by the FDA, the role of the “patent dance” in biosimilar litigation, and whether Europe’s experience with biosimilars has helpful lessons for our own situation. For those who weren’t able to make it, video of the event will be posted on the Petrie-Flom Center’s website soon.
But I wanted to write here about one of the very last questions we explored during the panel, because its implications are more far-reaching than we had the time to consider. The situation is as follows: In the decades after the Hatch-Waxman Act created a generic pathway for small-molecule drugs, companies typically specialized in developing either innovator or generic drugs, but not both. And although generic drug companies had great capacity for innovating in manufacturing, they were not research companies in the way that we think about innovator companies. The situation has changed somewhat over the years, as generic companies began to invest in innovative products, and as innovator companies put out authorized generics, but in general this broad division within industry has persisted.
In the biologic context, by contrast, the biosimilar applications being filed with the FDA are more typically being filed by innovator companies themselves or by subsidiaries thereof. For instance, the only biologic approved in the United States thus far is marketed by Sandoz, which is part of the innovator company Novartis. Instead of a situation in which innovators battle generic companies for access to the market, now innovator companies are battling themselves. There are a host of reasons for this development, most notably including the complex manufacturing processes involved in the biologics space and the need for the development of expertise there.