US Food and Drug Administration (FDA) officials provided insight into agency thinking on biosimilars approval standards in a New England Journal of Medicine
article published last week. The article, entitled "Developing the
Nation's Biosimilar's Program," gives an update on FDA's progress toward
implementing a biosimilar approval pathway as part of the Biologics Price Competition and Innovation Act.
The article shows that FDA has considered issues raised during its
November 2010 public hearing on biosimilars. On one key point,
interchangeability, the FDA authors maintain the first standard
biosimilar sponsors will have to meet will be biosimilarity, but they
regard interchangeability as a second, higher standard. A separate,
recent report suggests that US payers may require even more clinical
data than FDA for reimbursement.
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