Biologic Therapy Substitution to be Considered by World Health Assembly

by Renee Klink, Social Media Director

Recently two World Health Organization resolutions were approved for consideration at the 67th World Health Assembly, to convene this coming May in Geneva.  The resolutions make it likely that this global body will consider the policy issues impacting the development of biosimilar therapies and the terms by which biologic therapies might be substituted.  It is an issue that U.S and E.U. policymakers have been grappling with, and it now appears likely to be treated at the global level as well. Questions regarding product naming, patient safety and pharmacovigilance all might be raised as the WHA grapples with the proposed resolutions.

One resolution the Assembly will be considering relates to strengthening the regulatory system for medical products. Proposed by Australia, Colombia, Mexico, Nigeria, South Africa, Switzerland and the United States, this resolution calls for actions that will strengthen national regulatory systems as an essential component in ensuring safe and effective medical products. It recognizes the “increasing complexities of medical product global supply chains” and requests of the Director-General “to increase support and guidance for strengthening the capacity to regulate increasingly complex biological products…”

Another resolution, however, speaks even more directly to the access related issues that have been central to this debate. It focuses on costs, providing: “Conscious that similar biotherapeutic products could be more affordable and offer better access to treatments of biological origin, while ensuring quality, safety and efficacy [WHO] urges Member States…”  But just like policymakers in Washington, D.C. and the fifty state capitols, WHA delegates will have to determine what is the appropriate balance between, costs, access and safety.

These resolutions are likely to spark debate at the international level regarding the naming of biologic therapies and the terms for substitution, two issues that U.S. policymakers have been considering recently in Washington D.C. as well as in state capitols.  This past week even the Federal Trade Commission took up the issues when it hosted a meeting entitled “Follow-On Biologics Workshop: Impact of Recent Legislative and Regulatory Naming Proposals on Competition.” While the workshop agenda was dominated by lobbyists, and did not include the perspective of clinicians or patients, the Alliance for Patient Access joined with 14 other patient advocacy organizations in urging the commission to adopt distinguishable names for all biologic products, including biosimilars.

Whether policy is set at the national or international institution level, the ultimate threshold should be the safety of patients coupled with ensuring the ability of physicians to direct the best course of treatment for their individual patients.


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