US FDA aims to make it easier for biosimilars to reach patients
In the USA, the Food and Drug Administration has announced the availability of a draft guidance for industry which could smooth the path for biosimilars developers to gain interchangeable status for their products.
The draft guidance outlines considerations for switching studies intended to demonstrate that a biological product is interchangeable with a reference product.
The new approach aims to enhance the availability of biosimilar options, potentially leading to reduced healthcare costs and increased access to biological therapies.
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