FDA Approves Biosimilar Amjevita to Treat Crohn's Disease and Other Inflammatory Diseases
The FDA has approved Amgen’s Amjevita, a biosimilar to adalimumab for the treatment of Crohn’s disease and 6 other inflammatory diseases.
Amjevita is approved to treat:
adult moderate-to-severe Crohn's disease (rare)
moderate-to-severe rheumatoid arthritis
moderate-to-severe polyarticular juvenile idiopathic arthritis
moderate-to-severe chronic plaque psoriasis
moderate-to-severe ulcerative colitis
Amjevita was approved based on analytical, nonclinical, pharmacokinetic and clinical data supporting biosimilarity to adalimumab.
Amjevita an anti-TNF-α monoclonal antibody. The active ingredient of Amjevita is an anti-TNF-α monoclonal antibody that has the same amino acid sequence as, and is highly similar to, adalimumab.
The drug will be delivered in prefilled syringe and auto-injector presentations to support dosing in each of the approved indications.
About Crohn’s disease
Crohn's disease is an inflammatory bowel disease (IBD). It causes inflammation of the lining of your digestive tract, which can lead to abdominal pain, severe diarrhea, fatigue, weight loss and malnutrition. Inflammation caused by Crohn's disease can involve different areas of the digestive tract in different people.
Crohn's disease can be both painful and debilitating, and sometimes may lead to life-threatening complications.