USA – Biosimilars industry weighs in on BsUFA II interim assessment

Three biopharmaceutical trade associations have weighed in with generally positive positions on an interim assessment of how the US Food and Drug Association has fared in its efforts to increase transparency and improve communication in its process for reviewing and approving biosimilars.

The comments follow a 27 January public meeting hosted by FDA that shared results of an external review of the agency’s Program for Enhanced Review Transparency and Communication for 351(k) Biologics License Applications (BLAs), the regulatory pathway for biosimilar approvals. The interim assessment was part of FDA’s commitments under the Biosimilar User Fee Act for fiscal years 2018-2022 (BsUFA II).

The Pharmaceutical Research and Manufacturers of America (PhRMA) was one of four groups that submitted comments following the BsUFA interim assessment meeting…