Module 9 2024

05/09/2024

What is Interchangeability?

Defined as separate category in BPCI Very high hurdle • “same clinical result in any given patient;” and risk of alternating or switching no greater than use of reference product

⚫ Not regulatory concept

⚫ Decision at national level

⚫ Initially general view biosimilars not as interchangeable but view shifting

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Revised Interchangeability Requirements.

⚫ Draft biosimilar guidance for industry no longer recommends repeated switch study

⚫ Based on 13 interchangeable biosimilars, the risk to safety or of diminished efficacy following switching is considered insignificant.

⚫ Nine of the 13 interchangeable biosimilars have been approved without switching studies.

⚫ Value of interchangeable status diluted as FDA issued draft guidance (9/2023) that no longer recommends “labeling for interchangeable biosimilar products include an interchangeability statement.” FDA now recommends labeling as fo r non interchangeabile biosimilars.”

(30) New Medicines, Novel Insights: New FDA draft guidance: Implications for simplifying interchangeability for biosimilars in the US | LinkedIn

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