FDA Approves Fourth Biosimilar

September 26, 2016

September 26, 2016

FDA has approved Amgen's Amjevita as a biosimilar to AbbVie's Humira for multiple inflammatory diseases.

 

“This is the fourth FDA-approved biosimilar. The biosimilar pathway is still a new frontier and one that we expect will enhance access to treatment for patients with serious medical conditions,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research.

Amjevita is approved for the following indications in adult patients:

  • 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.