On Friday, September 23rd the FDA approved its fourth biosimilar, Amjevita (adalimumab-atto).
Amjevita (adalimumab-atto) was approved for seven adult indications of its reference product, Humira (adalibumab):
- 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; and
- moderate to severe plaque psoriasis.
Like the three previously-approved biosimilars, Amjevita (adalimumab-atto) is not approved as interchangeable. Only an interchangeable biosimilar may be substituted for the reference product by a pharmacist without the intervention of the health care provider who prescribed the reference product.
Read the FDA’s Press Release about that approval here.