Moving Toward a Biosimilars Pathway: The Lines are Drawn in Congress - The introduction of two rival bills has intensified the long-simmering debate on biosimilars regulation in the US. - BioPharm


Moving Toward a Biosimilars Pathway: The Lines are Drawn in Congress
The introduction of two rival bills has intensified the long-simmering debate on biosimilars regulation in the US.

BioPharm International
Volume 22, Issue 7

The FTC's Views on Biosimilars Legislation

As we went to press, the US Federal Trade Commission (FTC) issued its report on biosimilars. Entitled, Emerging Health Care Issues: Follow-on Biologic Drug Competition, the FTC report examined the effects on commercial competition that may result from the various regulatory schemes currently being considered. The report contained a number of findings and recommendations, among them finding that the longer exclusivity period proposed in the Eshoo biologics bill "is unnecessary to promote innovation by pioneer biologic drug manufacturers" (p. vi) and "imperils the efficiency benefits of a [follow-on biologics] approval process in the first place" (id. at p. vii). However, the report also recommended against adoption of a traditional Hatch-Waxman regulatory scheme as proposed in the Waxman biologics bill, contending that such a scheme would still have "anticompetitive consequences" (id. at p. x), and that "market dynamics counsel against [a follow-on biologics] exclusivity period" (id., at p. ix). This is because, in the FTC's view, market entry of a subsequent follow-on biologic after the approval of the first is "unlikely to cause a substantial price drop due to the high costs of developing and manufacturing" follow-on biologics in general (id.). Thus, the FTC report concludes, "market opportunities are likely to be sufficient to incentive [sic] development of interchangeable [follow-on biologics]" (id.), and that competition in the biologics market thus would be more akin to brand–brand competition rather than brand–generic competition in the small molecule arena. As a result, the FTC report does not favor the regulatory schemes proposed in either the Waxman or the Eshoo bills; instead, the report concludes that the most promising system would be one that would provide for an abbreviated FDA approval while relying on patent protection and market-based pricing to promote competition and spur innovation in the biologics marketplace.


Given the two different regulatory schemes provided by the Waxman and Eshoo bills, the debate over which proposal should prevail will no doubt continue to grow within the House and between the industry, trade, and consumer groups having sometimes-competing interests in the outcome of this debate. Healthcare reform is one of the top priorities of the Obama Administration, and the administration's 2010 budget proposal contained a framework for biosimilars regulation that appears to mirror the Hatch-Waxman pathway for small-molecule generic pharmaceuticals. As a result, we can likely expect heavy lobbying efforts from the generics and the biotechnology industries as Congress works toward a final bill. With the biopharma industry continuing to mature and beginning to deliver its long-promised benefits in the treatment and prevention of certain diseases, and as that industry is increasingly viewed as the "savior of the pipeline" for many traditional pharmaceutical companies, it becomes even more important that the debate is framed such that the outcome—a workable mechanism for FDA review and licensing of biosimilars—ultimately maximizes the protection of the interests of the public as well as those of both the biotechnology and generics industries.


The views expressed herein are those of the author and should not be attributed to former, present, or future clients or any employees of Sterne, Kessler, Goldstein & Fox P.L.L.C.

Brian J. Del Buono, PhD, is a director in the Biotechnology/Chemical Group at Sterne, Kessler, Goldstein & Fox, Washington, DC, 202.371.2600,

*Throughout this article, the term biopharma is used to refer to the combination of biotechnology and pharmaceutical companies. It is recognized that companies in these two industries face certain issues that are unique to one industry or the other. However, because the author believes that there is significant overlap in the primary issues relating to regulation of biosimilars that are important to both industries, and because a number of companies straddle the line between the two, biopharma has been used throughout this article to refer to the combination of the biotechnology and pharmaceutical industries.

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