Suggestions on Biosimilar Container Closure Draft

Three stakeholders have submitted general and specific comments to FDA on the agency’s draft guidance on considerations for container closure and device constituent parts for biosimilar and interchangeable biosimilar products. The Biosimilars Forum comment letter made these general points:

• other tools, including qualitative human factor studies, effectively evaluate user interface differences and comparative use human factor studies should be a last resort; and
• FDA must address reference product lifecycle management strategies.

The Pharmaceutical Research and Manufacturers of America (PhRMA) response says PhRMA generally supports issuance of the draft guidance and has identified several aspects that would benefit from additional clarification and examples to promote consistent implementation and avoid unnecessary uncertainty during product development and review. It says FDA should:

• clarify the draft guidance scope;
• clearly articulate how key concepts relate to statutory standards; and
• clarify how the terms “dosage form” and “presentation” differ.

The Association for Accessible Medicines and its Biosimilars Council say they appreciate the agency’s efforts to provide greater clarity on the development of biosimilar and interchangeable biosimilar combination products. Their general comments say FDA should:

• adopt a risk- and science-based approach that supports appropriate device innovation and competition;
• clarify that alternative human factors evidence can support biosimilar and interchangeable presentation; and
• provide predictable pathways when reference presentations are unavailable, discontinued, or materially changed.