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# CDER Working on 2 Biosimilar Guidances for Release This Year
- URL: https://www.fdaweb.com/cder-working-on-2-biosimilar-guidances-for-release-this-year/
- Published: 2016-06-20T12:00:00.000Z
- Updated: 2026-09-14T21:10:44.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5135991

CDER plans to release biosimilar guidance documents by the end of the year on statistical considerations for analytical similarity data, and interchangeability data standards, according to CDERassociate director for therapeutic biologics **Leah Christl**. Speaking at a 6/20 Alliance for Health Reform biosimilar briefing, Christl said that the science around analytical comparisons continues to grow. “I think the biosimilar development space is actually pushing the technology, and we know more now about the reference products from the biosimilars actually analyzing those reference products than we did before,” she said.

Asked to elaborate on the data needed for demonstrating biosimilar interchangeability, Christl told the briefing that interchangeability will be an additional standard over biosimilarity. “We don’t say it is a higher standard because biosimilarity is not a lesser standard... So in addition to biosimilarity, a sponsor would need to provide data or information that demonstrates that the product is expected to produce the same clinical result in any given patient. And for products given more than once to a patient, that the impact of switching or alternating on safety and effectiveness of the product is evaluated in comparison to just staying on the reference product.”

Christl told the briefing that she was limited in what she could say in terms of the data elements to support interchangeability because the guidance is still in development. “But folks can look at the statutory definition and determine there is going to be some additional data or information that will have to go towards addressing those elements that are part of the definition of interchangeability,” she said. “I don't think people should assume in all cases that this would have to be clinical data or that there will have to be an evaluation of switching or alternating in every condition of use, but it will need to be addressed. I think it remains to be seen, just as we have done in biosimilarity, that there is no one-size-fits-all and it will be a step-wise development program. We look at the totality of the evidence to support that standard.”