Drug development

Biosimilar medicines

A biosimilar is highly similar to a reference biological medicine and is not simply a chemical generic. Comparability addresses quality, activity, safety, efficacy and immunogenicity.

Sources and scope checked: 3 October 2026 · Guide version 1

Scope: The EMA framework does not automatically define every country’s substitution rules.

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Prepare your evidence before a decision

Mark the prompts for which you have organised evidence. Completion tracks preparation; it does not establish product or site compliance.

Document the reference medicine and regulatory basis.
Connect analytical comparability to observed differences.
Identify additional evidence needed to address uncertainty.
Review traceability, safety planning and approved indications.

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Biosimilar medicines

Prepare your evidence before a decision

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