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

The Generics Industry

In contrast, the generics pharmaceutical industry sees things quite differently. The Generic Pharmaceutical Association (GPhA) has stated its opposition to the Eshoo bill, calling it "the wrong road for patients looking for safe and affordable biogeneric medicines, particularly during these difficult economic times" and "a long route filled with needless roadblocks that will keep patients from getting needed medicines in a timely manner."8

GPhA contends that there is little justification for the longer exclusivity period provided by the Eshoo bill compared to that provided by the Waxman bill, stating that the former "will only benefit brand companies by erecting barriers including an unprecedented and unjustifiable 14 years of market exclusivity" and that "there is a minimal difference of less than eight months longer in the development of biopharmaceuticals when compared to traditional pharmaceuticals, [so] there is little justification for excessively expanding exclusivity beyond the Hatch-Waxman model."8 GPhA also issued statements in support of the Waxman bill in the House and its counterpart in the Senate, contending that because these bills are based in large part on "our healthcare system's successful experience with generic medicines for the past 25 years" under the Hatch-Waxman rubric, it would "achieve the much-needed balance between pharmaceutical competition and innovation for the benefit of consumers, payors and state and federal governments."9,10 GPhA had previously come out in support of the opening remarks of President Obama's 2010 budget proposal, which stated that the ideal system for review and licensing of biosimilars would be modeled in large part on the Hatch-Waxman Act.11,12

Teva Pharmaceuticals, one of the largest manufacturers of generic pharmaceutical products in the world, echoed the sentiments of GPhA. Debra Barrett, Teva's senior vice president of government affairs, was quoted as saying that the Eshoo bill "clearly is written to protect brand-name drugs and their innovators' government-granted monopoly at the expense of access and innovation."3

Thus, it is clear that the battle lines have been drawn between the biotechnology industry and its advocates on one side, and the generics pharmaceuticals industry and its advocates on the other. This battle is shaping up to be reminiscent of the one that took place 25 years ago during the debate over the bills that ultimately became the Hatch-Waxman Act and that set the stage for the development of the generics pharmaceutical industry itself. This time around, however, the generics industry is far more robust than it was 25 years ago, and the industry groups and Congress also have 25 years' worth of experience in the small-molecule arena to draw from as they debate the most appropriate system for regulation of biosimilars.


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