FDA updates interchangeability designations for six adalimumab biosimilars
FDA updated interchangeability designations for six adalimumab biosimilar products — Hadlima, Hyrimoz, Cyltezo, Yusimry, Hulio, and Idacio — following completion of switching study requirements. Interchangeable biosimilars may be substituted for the reference product (Humira) by a pharmacist without prescriber intervention in states that permit automatic substitution, potentially reducing treatment costs by 60–80% vs the originator.
FDA updated interchangeability designations ↗ for six adalimumab biosimilars: Hadlima (Samsung Bioepis), Hyrimoz (Sandoz), Cyltezo (Boehringer Ingelheim), Yusimry (Coherus), Hulio (Mylan/Viatris), and Idacio (Fresenius Kabi). The interchangeability designation means a pharmacist may substitute these products for the reference product (Humira) without prescriber intervention, provided state pharmacy law permits automatic substitution.
What interchangeability means
Under the Biologics Price Competition and Innovation Act (BPCIA) ↗, a biosimilar can only be designated interchangeable after demonstrating that alternating or switching between the reference product and the biosimilar does not produce greater risk of diminished clinical response or adverse effects than continued use of the reference. The required switching studies for adalimumab biosimilars compared patients who stayed on Humira against those who switched multiple times. Pharmacokinetics, immunogenicity, and efficacy outcomes were equivalent. A non-interchangeable biosimilar is still clinically equivalent but requires prescriber authorisation to substitute.
Cost and access implications
Adalimumab (Humira; AbbVie) was the world's top-selling drug for years, with US annual costs of $70,000–90,000 per patient. Following patent expiry in 2023, biosimilars entered the US market. As of October 2026, biosimilar adalimumab is priced 60–80% below Humira's wholesale acquisition cost. With interchangeability, pharmacy-level substitution can occur at dispensing — accelerating uptake. The ASHP biosimilars resources ↗ and FDA biosimilar product table ↗ list all currently approved and interchangeable products.
Clinical considerations for switching
Clinically, biosimilar adalimumab products differ in citrate-free formulation (reducing injection site pain), concentration (100 mg/mL vs 50 mg/mL for Humira), and device (prefilled syringe vs autoinjector). These device differences are not clinical efficacy differences but may affect patient adherence. For patients stable on Humira, guidelines from ACR ↗ and EULAR ↗ support non-medical switching to biosimilars with appropriate monitoring. Immunogenicity monitoring (anti-drug antibody testing) should continue as per routine practice. See Strand et al. Ann Rheum Dis 2023 ↗ for real-world switching data.
FAQ
What triggers an FDA label update?
Label updates can be triggered by post-market safety data from the FAERS database ↗, new clinical trial results, manufacturer-initiated reviews, or FDA-directed safety communications. The FDA can require label changes under 21 CFR 314.81 or negotiate them with manufacturers. See the FDA Safety-related Labeling Changes (SrLC) database ↗ for a full history.
Where is the updated label published?
Updated labels are published on DailyMed (NLM) ↗ and Drugs@FDA ↗. DailyMed is typically the most current source, as manufacturers submit label updates there directly.