FDA Pulls Biosimilar Analytics Guidance Amid Comments on Flexibility

The FDA withdrew its draft guidance on analytical studies of biosimilars Thursday and said it plans to issue an amended version that will give sponsors “appropriate flexibility.”

Public comments on the agency’s September 2017 draft took issue with recommendations for the number of lots of reference products to be sampled. The agency called for a minimum of 10 reference product lots and recommended alternative assessments in cases where access to the reference product is limited.

Commenters also questioned a requirement that lots come from U.S.-sourced reference products as well as the guidance’s proposed statistical methods for determining analytical similarity.