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# Interpreting Sameness Guidance ‘Helpful’: BIO
- URL: https://www.fdaweb.com/interpreting-sameness-guidance-helpful-bio/
- Published: 2020-06-25T12:00:00.000Z
- Updated: 2026-09-14T16:19:41.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147092

The Biotechnology Innovation Organization (BIO) says an FDA draft guidance on interpreting sameness of gene therapy products under the orphan drug regulations is helpful and contains a framework drafted in a way that supports the development of innovative gene therapy products. The BIO comment [letter](ttps://www.regulations.gov/document?D=FDA-2019-D-5392-0007) says the association appreciates the three bulleted “cases” provided by FDA in the draft and believes they are sufficiently exhaustive in demonstrating under what circumstances the agency would consider two gene therapy products to be either the same or different. “We do request that FDA clarify that gene editing products are out-of-scope for the guidance and will be subject to case-by-case determinations,” the letter says.