USA – Interchangeable Biosimilars: FDA Finalizes Guidance

The US Food and Drug Administration (FDA) on Friday finalized a long-awaited guidance spelling out how biosimilars can achieve an interchangeable status, which means they may be substituted for the reference biologic without a prescriber intervening.

No interchangeable biosimilars have been approved in the US yet, and the number of companies seeking approval for an interchangeable has remained at just one, with Boehringer Ingelheim publicly disclosing that it’s begun an interchangeability study for its adalimumab biosimilar.

But former FDA Commissioner Scott Gottlieb said last month that interchangeable insulin products are likely coming to the US in the next couple of years. And final interchangeability guidance will provide sponsors with more certainty on how to develop interchangeable products.

Changes in Final Guidance

The final guidance is seven pages shorter than the draft and does not include two appendices that were included in the draft on comparative use human factors studies.

Commenters on the draft took issue with terms that needed further clarity, such as “residual uncertainty” and “fingerprint-like,” which is used in the draft to describe the similarity between the proposed interchangeable product and the reference product…