FDA Approves Fourth Biosimilar

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.