Under a settlement agreement with AbbVie, Amgen introduced Amjevita™ (adalimumab-atto) injection for subcutaneous (SC) use, its biosimilar to Humira® (adalimumab) injection 50mg/mL (low concentration) on Jan. 31, 2023. FDA-approved in 2016, Amjevita, a citrate-free formulation, is the first of several Humira biosimilars to become available in the U.S. The next ones, including some that are interchangeable with Humira, are expected to launch beginning this summer. Amjevita is approved for treating most of the same inflammatory conditions as Humira, not including hidradenitis suppurativa or uveitis. The wholesale acquisition cost (WAC) of a 40mg Amjevita pen device is either $3,115 per month (55% less than the list price of Humira) or $6,576 per month (5% less than the list price of Humira). It is available through open distribution; Accredo has access. Full prescribing information is here.
At a Glance
- Brand (Generic) Name: Amjevita(adalimumab-atto)
- Manufacturer: Amgen
- Biosimilar to: Humira
- Indications: Amjevita is approved for treating adults who have ankylosing spondylitis, plaque psoriasis, psoriatic arthritis (PsA) rheumatoid arthritis (RA), and ulcerative colitis (UC). It has additional indications for Crohn’s disease in patients as young as six years old, and polyarticular juvenile idiopathic arthritis (pJIA) in patients as young as two years old.
- Dosage Forms Available: 40mg/0.8mL and 20mg/0.4mL single-dose prefilled syringes and 40mg/0.8mL single-dose prefilled SureClick® autoinjectors for SC injection
- Launch Date: Jan. 31, 2023
- Estimated Annual Cost: Approximately $37,380 or $78,912
- Amjevita is not considered a generic medication and it is not automatically interchangeable with Humira or any other Humira biosimilar.
- A number of other biosimilars to Humira will be launched over the second half of 2023.
- Like all drugs that block the activity of tumor necrosis factor (TNF), Amjevita has a boxed warning that outlines the increased chances that cancer and serious infections may be associated with their use.
- Prospective patients should be screened for tuberculosis (TB) before starting treatment and periodically while therapy continues.
- An updated version of the “Humira Biosimilars” Issues Document, which includes the launch of Amjevita, is attached.