The Food and Drug Administration has issued new interchangeability designations for at least two adalimumab biosimilars in recent days, which ends exclusivity for Alvotech and Teva’s Simlandi for the most-commonly prescribed dose.
Last week, Celltrion announced receiving their designation for Yuflyma, and today, Samsung Bioepis and Organon released a press statement indicating that Hadlima was now also interchangeable with the reference product Humira. Both products are interchangeable across all dosing and concentrations options they offer.
Boerhinger Ingelheim received this designation for the 40 mg/0.4 mL high-concentration formulation (HCF) dose for their product Cyltezo. Cyltezo was the first adalimumab product to receive the designation for the low-concentration formulation (LCF). Announcements from other manufacturers may follow in the coming days, as the HCF exclusivity period for Simlandi’s 40-mg dose expired last week.
TABLE: ADALIMUMAB BIOSIMILAR INTERCHANGEABILITY STATUS*
| Brand | Manufacturer/ Marketing Partner | Interchangeable Doses |
| Yuflyma | Celltrion | HCF: 20 mg, 40 mg, 80 mg |
| Cyltezo | Boehringer Ingelheim | LCF: 10 mg, 20 mg, 40 mg HCF: 40 mg |
| Amjevita | Amgen | LCF: 10 mg, 20 mg, 40 mg HCF: 20 mg, 80 mg |
| Abrilada | Pfizer | LCF: 10 mg, 20 mg, 40 mg |
| Simlandi | Alvotech/Teva | HCF: 20 mg, 40 mg, 80 mg |
| Hadlima | Samsung Bioepis/Organon | LCF: 40 mg |
| Hulio | Biocon | LCF: 20 mg, 40 mg |
| Hyrimoz | Sandoz | LCF: 10 mg, 20 mg HCF: 10 mg, 20 mg, 80 mg |
*As of May 30, 2025.
Note: Interchangeability does not necessarily apply to both prefilled syringe and autoinjector forms. Please see the FDA’s Purple Book for more details.
Sources: FDA Purple Book and corporate press releases.
LCF = Low-dose formulation, HCF = high-dose formulation.
Indeed, tracking adalimumab interchangeability is complex: Other manufacturers have received interchangeability designations for specific, less-commonly prescribed doses. For example, Amjevita is interchangeable across its available LCF doses today but only for its 20-mg and 80-mg HCF doses. Similarly, Sandoz’s Hyrimoz is interchangeable in its 10-mg and 20-mg LCF formulations (but only as delivered by prefilled syringe, not autoinjector pen), as well as its 10-mg, 20-mg, and 80-mg HCF doses (prefilled syringe only), but not the most popular 40-mg HCF form.
The principal paradox remains, however: Interchangeability has not provided any advantage to biosimilars to date, in terms of market access, uptake, and (mis)perception of better quality or reliability. Yet, biosimilar manufacturers continue to seek this designation despite a growing consensus by industry experts, federal regulators, and legislators that the designation should be dropped altogether.
(Note: This post was modified on May 30, 2025 to reflect the latest developments.)
