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The Biosimilars Working Group (BWG) has published a Primer on Biosimilar-Related Regulatory Topics for Regulatory Reviewers.
The Primer provides a compilation of publicly available information on common aspects of biosimilar regulation and common questions and their answers.
This Primer is intended to help regulatory authorities who are in the process of developing their own approaches to the regulation of biosimilars by providing a summary of the approaches taken by other regulators on these questions.
The document and more information can be found linked on the BWG Activities webpage .