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# Biosimilar, Interchangeable Pathway ‘Working Well’: BI
- URL: https://www.fdaweb.com/biosimilar-interchangeable-pathway-working-well-bi/
- Published: 2019-06-04T12:00:00.000Z
- Updated: 2026-09-15T01:30:29.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144257

Boehringer Ingelheim says its experience as the only biosimilar sponsor to have publicly announced conducting a switching study, to support an interchangeability designation for its biosimilar Cyltezo (adalimumab-adbm), shows that the FDA pathway for biosimilars and interchangeable biologics “is working well as it is currently designed.” Commenting on an agency final guidance on considerations in demonstrating interchangeability with a reference product, the company [says](https://www.regulations.gov/contentStreamer?documentId=FDA-2017-D-0154-0063&attachmentNumber=1&contentType=pdf&ref=fdaweb.com) the current pathway has resulted in a safe, effective, quality FDA-licensed biosimilar or interchangeable biologic as required by the Biosimilars Price Competition and Innovation Act.

BI says it also recognizes the need for case-by-case decisions and concurs with current approaches being taken by FDA as long as the agency is also consistent and flexible as the science and healthcare priorities evolve, and as it is currently being applied to already approved biologics.

The letter says FDA can optimize the biosimilars pathway and the broader competitive environment for biologics in the U.S. by exhibiting additional flexibility surrounding the data burden required to show biosimilarity and interchangeability. Specifically, it asks the agency to take into account the complexity of the molecule when determining what data is needed to show biosimilarity and interchangeability, but not to require an excess of data beyond what is sufficient.

Finally, BI says that to ensure access and maximize competition, the interchangeability designation of Section 351(k) must not require studies in all indications and presentations. “We would request the agency consider that both exclusivities and patents could be used to try to block interchangeability,” it says. “Just as generics and even biosimilars have had label carve-outs, this must remain allowable for those biosimilars subsequently designated as interchangeable.”