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FDA’s draft guidance on demonstrating interchangeability with a reference product cracks open a door into a generics-like marketplace but, in many settings, manufacturers may decide it isn’t worth the expense.

The guidance sets a high scientific and technical bar for interchangeability designation that some companies may not be able to reach. Especially for highly complex biologics, FDA may require more precise analytical characterization than is needed to obtain approval as a biosimilar. For any biologic that is likely to be administered more than once, the agency will require studies to demonstrate that switching a patient back and forth between a proposed interchangeable and a reference biologic is safe and doesn’t alter efficacy. ...