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Biosimilar Interchangeability Guidance- An FDA Approach

Since January 2017, the FDA was working on long-awaited Biosimilar Interchangeability Guidance for public. The guidance provide information on  biosimilar interchangeability. Comments came from big pharmaceutical manufacturers like Pfizer, Boehringer Ingelheim, Sandoz, Johnson and Johnson or Genentech or from organisations, e.g the American Society of Clinical Oncology, the Academy of Managed Care Pharmacy, the Combination Products Coalitions or the Biosimilars Forum.

Aim of the guideline

The draft guidance so far reflects FDA’s expectation that sponsors will provide data from one or more switching studies to support a demonstration of interchangeability for a proposed product that is intended to be administered more than once. Moreover, FDA’s position that sponsors should use a US-licensed comparator in such studies may present a challenge for sponsors of proposed interchangeable products for which the reference product is subject to a risk evaluation and mitigation strategy (REMS), if that REMS places restrictions on access to the reference product. In addition, FDA asserts that, in some cases, a proposed interchangeable product may need to be licensed first as a biosimilar to enable the sponsor to gather appropriate post-market data before the product can be licensed as an interchangeable.


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