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

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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

COMMENTS BY KEY CONSTITUENCIES

The interested constituencies on both sides of the biosimilars debate have provided comments for and against each bill and the regulatory schemes envisioned by those bills.

The Innovator Industry

The biotechnology industry generally favors the Eshoo bill, particularly because of its provision of longer exclusivity periods for newly approved biologics. For example, the Biotechnology Industry Organization (BIO), one of the largest trade and advocacy organizations in the biotech industry that counts many of the key biotech corporations among its members, said in a statement that it favors the Eshoo bill, calling it "an effective, reasonable and safe pathway to biosimilars . . ." that "provides patients with the right balance between innovation and competition."2 Jim Greenwood, president and CEO of BIO, was quoted as saying that the Eshoo bill "will help reduce costs by enabling additional competition among biologics but at the same time help safeguard patient safety by requiring demonstration of the purity, safety and effectiveness of biosimilars."3 In contrast, BIO believes the Waxman bill "does not strike the necessary balance for patients or the economy," contending that the bill "seeks to cut prices but instead cuts corners."4 BIO issued a similar statement of disdain for the companion bill introduced into the US Senate by Sen. Schumer, contending that S. 726 "follows its companion bill in the House . . . through the looking glass to a world of biosimilars that would jeopardize patient safety and undermine future medical breakthroughs."5

The Pharmaceutical Research and Manufacturers of America (PhRMA), a pharmaceuticals industry trade and advocacy group whose members include the largest brand name pharmaceutical companies and their supporters, has expressed a similar view to that of BIO. PhRMA's senior vice president Ken Johnson was quoted as saying that the Eshoo bill "represents a positive step forward" at least in part because of the Eshoo bill's requirement for more extensive clinical trials than are required in the Waxman bill.3

In addition, many big companies have supported the Eshoo bill over the Waxman bill. For example, Robert Armitage, senior vice president and General Counsel of Eli Lilly & Co., was quoted as saying that the Eshoo bill "makes certain that innovator companies can continue to make these types of investments in new therapies for patients, and that, once a reasonable period of time has passed for recouping its investment, generics companies can copy those innovations in a safe, scientifically sound manner."6 Analogous statements in support of the Eshoo legislation were made by representatives from Johnson & Johnson and Amgen Corporation.3,7 The primary issue driving them to favor the Eshoo bill over the Waxman bill, according to these industry advocacy groups and biopharma companies, is the longer exclusivity period provided in the Eshoo bill. According to Armitage, biotechnology innovation "entails many years of research, massive investments and high risk," and it is only with the longer exclusivity period provided by the Eshoo bill that such investment and risk would be undertaken by the innovator companies.6 Similarly, Audrey Phillips, an executive director of public policy for Johnson & Johnson, was quoted as saying that the exclusivity provided by the Waxman bill "is far from sufficient," contending that companies need about 12 years of exclusivity to have the appropriate financial incentive to innovate new biologic products.7


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