BioCentury
ARTICLE | Politics & Policy

BIO wants more FDA clarity on biosimilarity hierarchy

August 15, 2014 12:24 AM UTC

The Biotechnology Industry Organization asked FDA to clarify what type or scope of information is needed to differentiate a "similar" biosimilar product from one that is "highly similar" or "highly similar with fingerprint-like similarity" to its reference product. The request came in BIO's comments on FDA draft guidance on pharmacological data requirements for biosimilars. According to the draft guidance, FDA will characterize its assessment of biosimilarity into one of four levels depending on the type, nature and extent of any structural and functional differences (see BioCentury Extra, May 13).

BIO also opposed the agency's concept of using multiple pharmacodynamic markers to address the absence of a single PD biomarker or endpoint, arguing that the approach runs the risk of "merely increasing the quantity of data" without improving quality and interpretability of data. Additionally, BIO noted that some classes of potential biosimilars have specific development issues that cannot be generalized or extrapolated to other classes and emphasized the need for class-specific guidance -- an approach the group said EMA has already adopted. Comments on the guidance were due Tuesday. ...