Industry Leaders Debate Follow-on Biologics Pathway - Pharmaceutical Technology

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Industry Leaders Debate Follow-on Biologics Pathway
The organizations' presidents discuss market exclusivity, approval processes, and pending legislation.

Pharmaceutical Technology
Volume 33, Issue 5, pp. 112-114

In this case, however, our two industries principally disagree on the appropriate length of exclusivity. We believe that the proven successful Hatch–Waxman exclusivity model provides an appropriate length of exclusivity to ensure appropriate return on BIO's investment in innovation; allows for the appropriate incentive for the development of new treatments; and creates savings from generic-drug competition.

This model seems especially appropriate when one considers that there is a minimal difference (less than eight months) between the development of a biopharmaceutical product and the development of a traditional pharmaceutical product.

Accordingly, there is little justification for excessively expanding exclusivity beyond the Hatch–Waxman model. Excessive exclusivity means that it will be decades before patients have access to affordable biogeneric medicines. For the countless patients who are choosing between paying for their medicines and putting food on their tables, waiting decades is simply not an option.

In November 2008, former House Ways and Means Committee Chief Economist and American Enterprise Institute Research Fellow Alex Brill released a white paper that demonstrated that BIO's argument for a long period of exclusivity is invalid. He argued that a period similar to Hatch–Waxman's five years of market exclusivity provides the necessary incentives to promote innovation in novel biologics while opening the doors for timely patient access to less costly biogenerics.

What policymakers and consumers should know is that market exclusivity protection is separate and distinct from the patent protection and corresponding patent extensions afforded to brand biopharmaceuticals today.

Yet, as BIO knows, market exclusivity acts as an absolute shield to their patents. Thus, from a practical perspective, considering the time it takes to develop a drug, extending market exclusivity beyond the Hatch–Waxman period would block the introduction of generic competition for nearly 20 years, derailing any potential cost savings to Americans and our healthcare system.

Kathleen Jaeger is president and CEO of the Generic Pharmaceutical Association, tel. 703.647.2480,


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