PhRMA Seeks Changes in Bio Interchangeability Guidance

Pharmaceutical Research and Manufacturers of America (PhRMA) says an FDA draft guidance on considerations in demonstrating interchangeability with a reference product is “a helpful step to provide further transparency into FDA’s evolving approach regarding the need for a switching study or studies to support an interchangeability determination for a therapeutic protein biosimilar….” The PhRMA comment letter says the draft guidance would benefit from clarification and expansion in several respects:

• addressing key open scientific questions about interchangeability and committing to refining the guidance based on future learnings from the Biosimilars User Fee Act commitments to advance the science on interchangeability under the regulatory science pilot program;
• addressing procedural issues concerning an interchangeability determination; and
• clarifying terminology.

PhRMA provides additional details for each of its three requested areas of change.