Snapshot

The Biologics and Biosimilars Pathway (OS-45) pathway has been developed by the Agência Nacional de Vigilância Sanitária (ANVISA) of Brazil.

This pathway can be used where Biologics and biosimilars.

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

When relevant, the agency relies on prior decisions from EU-EMA United States

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