Amjevita™ (adalimumab-atto), a citrate-free biosimilar to Humira® (adalimumab), is now available in the US.
The indications for Amjevita, a tumor necrosis factor (TNF) blocker, are shown in the Table. The Food and Drug Administration (FDA) approved Amjevita in September 2016 based on data demonstrating that the biosimilar product and the reference product were highly similar, and that there were no clinically meaningful differences between the agents. Amjevita is not interchangeable with Humira.
Table. Amjevita Indications
|Rheumatoid arthritis (RA): reducing signs/symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA; may be used alone or with methotrexate (MTX) or other non-biologic DMARDs.|
|Juvenile idiopathic arthritis (JIA): reducing signs/symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older; may be used alone or with MTX.|
|Psoriatic arthritis (PsA): reducing signs/symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA; may be used alone or with non-biologic DMARDs.|
|Ankylosing spondylitis (AS): reducing signs/symptoms in adult patients with active AS.|
|Crohn disease (CD): moderately to severely active CD in patients 6 years of age and older.|
|Ulcerative colitis (UC): moderately to severely active UC in adult patients.|
|Plaque psoriasis (PsO): treating adult patients with moderate to severe chronic PsO who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate.|
Amjevita is supplied in a 40 mg/0.8 mL single-dose prefilled SureClick autoinjector, and in 20 mg/0.4 mL and 40 mg/0.8 mL single-dose prefilled syringes.
- Amjevita™ (adalimumab-atto), first biosimilar to Humira®, now available in the United States. News release. Amgen. Accessed January 31, 2023. https://www.prnewswire.com/news-releases/amjevita-adalimumab-atto-first-biosimilar-to-humira-now-available-in-the-united-states-301734177.html.
- Amjevita. Package insert. Amgen; 2022. Accessed January 31, 2022. https://www.pi.amgen.com/-/media/Project/Amgen/Repository/pi-amgen-com/Amjevita/amjevita_pi_hcp_english.pdf.
This article originally appeared on MPR