Molecular “Sameness” Is the Key Guiding Principle for Extrapolation to Multiple Indications

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Excerpt

In the US, in order to allow the US Food and Drug Administration (FDA) to approve follow‐on biological products that are “essentially the same”1 as the originator reference biologics, new legal authority was needed. Biosimilars were enabled by the Biologics Price Competition and Innovation Act (BPCIA), comprising Title VII of the Patient Protection and Affordable Care Act (PPACA), enacted 23 March 2010. This gave the FDA the legal authority to approve a biosimilar that refers to a single previously approved biologic, at least 12 years after the approval of that product, as long as the biosimilar candidate is highly similar to that reference and no clinically meaningful differences are expected.
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