The US FDA has finalized its 2012 drafts on biosimilarity with three guidance documents. The first guidance presents the approach for sponsors to obtain evidence showing biosimilarity and by the FDA in reviewing applications for biosimilars. It also provides some clarifications in its recommendations. It encourages frequent consultation with the FDA during the early stages of drug development because the testing and analyses deemed sufficient to establish biosimilarity will vary by individual product. The second document addresses the chemistry, manufacturing and controls for biosimilar applications. The guidance provides added detail regarding the data needed for some studies involving comparator biologics not licensed in the US, and the characterization of the differences in impurities between biosimilars and their reference drugs. The third guidance is a Q&A document with some finalizations and omissions compared with the prior version, to be updated as necessary. Issues not resolved in the documents include naming, requirements for establishing interchangeability, standards for indication extrapolation and labeling requirements.

Source: The National Law Review

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