WASHINGTON -- A biosimilar version of the blockbuster rheumatology drug adalimumab (Humira) was approved Friday, .
The product, made by Amgen, will be sold as Amjevita and was approved for most of the same indications for adults as adalimumab. These include:
- Moderately to severely active rheumatoid arthritis
- Active psoriatic arthritis
- Active ankylosing spondylitis (an arthritis that affects the spine)
- Moderately to severely active Crohn's disease
- Moderately to severely active ulcerative colitis
- Moderate to severe plaque psoriasis
It can also be used to treat moderately to severely active polyarticular juvenile idiopathic arthritis in children age 4 and older, the FDA said.
The agency emphasized that the drug was not approved to be interchanged freely with adalimumab; to be designated as "interchangeable" would require that, in addition to meeting the agency's biosimilarity standard, the product would be "expected to produce the same clinical result as the reference product in any given patient," according to the FDA.
It's the fourth biosimilar drug to win FDA approval. Others include copies of etanercept, filgrastim, and infliximab.
Also on Friday, the FDA announced that : tumor necrosis factor receptor-associated periodic syndrome, also known as TRAPS; hyperimmunoglobulin D syndrome, also known as mevalonate kinase deficiency; and familial Mediterranean fever.
Canakinumab was previously approved for cryopyrin-associated period syndrome and for systemic juvenile idiopathic arthritis.