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# Cyltezo Exclusivity End Dates Recommended
- URL: https://www.fdaweb.com/cyltezo-exclusivity-end-dates-recommended/
- Published: 2023-11-09T12:00:00.000Z
- Updated: 2026-09-14T14:15:44.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155763

The CDER Office of Therapeutic Biologics and Biosimilars (OTBB) has recommended a determination that the first interchangeable exclusivity (FIE) expired on 4/15 for Boehringer Ingelheim’s Cyltezo (adalimumab-adbm), 40mg/0.8mL and 20mg/0.4 mL for subcutaneous use, and on 9/18 for Cyltezo injection 10mg/0,2mL for subcutaneous use. The Cyltezo products are licensed biosimilars to AbbVie’s Humira.

In a 9/29 memo [republished](https://www.fda.gov/media/173749/download?attachment&ref=fdaweb.com) 10/3 with typographical corrections, OTBB says it is discussing the determination of the FIE when patent litigation is initiated in connection with an application for a proposed biosimilar and ends before the submission of a supplement for interchangeability for the first interchangeable biosimilar product.

In the case being considered, Humira is the reference product, the Cyltezo products are the first interchangeable products for the specified dosages, and Pfizer’s Abrilada (adalimumab-afzb) is a licensed biosimilar for the same dosages.

Pfizer submitted an sBLA seeking to license the three dosages of Abrilada as interchangeable with the Humira reference products.

The memo says the FDA *Purple Book* indicates unexpired periods of FIE for the three Cyltezo dosages that block approval of the products in the Abrilada supplement.

The memo contains a lengthy discussion of the reasoning OTBB applied in determining the FIE expiration dates.