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October 18, 2021October 18, 2021 – The U.S. FDA has announced that Boehringer Ingelheim's Cyltezo® (adalimumab- adbm) will be automatically interchangeable with its reference product, AbbVie's Humira® (adalimumab), upon launch in the U.S. market.
- There are multiple FDA-approved biosimilars for Humira, but to date, Cyltezo is the only one approved as interchangeable.
- This decision means that pharmacists will be able to dispense Cyltezo as a substitute for Humira, even if the prescription was written for Humira. In most cases, prescribers must submit a prescription specifically for a biosimilar for it to be dispensed instead of its reference product.
- Cyltezo is only the second biosimilar to be approved as automatically interchangeable with its reference product in the United States. The first was Mylan's Semglee® (insulin glargine-yfgn), a biosimilar to Sanofi's Lantus® (insulin glargine).
- Although Cyltezo was FDA approved as a Humira biosimilar in August 2017, it is not expected to be available until 2023 due to a patent settlement.