FDA approves the first-ever interchangeable biosimilar for Humira, but the real story is what happens next

By AIQ Author | Nov. 10, 2021

Late last week, the FDA approved the first interchangeable biosimilar monoclonal antibody: Cyltezo, a biosimilar to AbbVie’s adalimumab (Humira). However, the biologic won’t enter the U.S. market until 2023 due to agreements highlighting the issues around the monopoly created by AbbVie’s Humira patent thicket, and there are several pending developments that may further complicate the regulatory landscape.

Regulatory Background

In 2009, the Biologics Price Competition and Innovation Act (BPCIA) sought to increase biologics competition by creating a pathway for the approval of biosimilars.

The BPCIA, implemented as part of the Patient Protection and Affordable Care Act, introduced section 351(k) to the Public Health Service Act (PHS) Act, which defines biosimilar and interchangeable products and approval standards for each.


Demonstrating biosimilarity and interchangeability is a two-step process.

Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum.


For interchangeable products, however, the ACA set stricter standards for approval.

Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum.


In July 2021, the FDA approved the first ever interchangeable insulin product.

Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum.


1 Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum.

2 Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum.


To contact the author of this analysis, please email Kirsten Messmer ([email protected])
To contact the editor of this analysis, please email Alec Gaffney ([email protected])

© 2021 POLITICO LLC