FDA Announces Closer Ties to WHO on Biologics

U.S. FDA News

On May 31, 2016, the FDA issued a notice that FDA’s Center for Biologics Evaluation and Research (FDA/CBER) intends to “enhance technical collaboration and cooperation between the FDA, WHO, and its member states to facilitate strengthening regulatory capacity and support product development and standardization activities to increase access to safe and effective biologicals globally.” As the Big Molecule Watch has reported, the WHO has regularly weighed in on such hot topics as the naming of biosimilars as part of its effort to reduce barriers to patient access to costly biologics. Closer cooperation between CBER and WHO may mean that the two organizations will be more aligned on such contentious issues in the future. It may also signal WHO’s intent to leverage the hard-won experience of the EMA and FDA in approving biosimilars by promoting similar regulatory approaches in countries that have less experience with implementing biosimilar programs.

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