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Amjevita approved by FDA for multiple inflammatory diseases.

The U.S. Food and Drug Administration today approved Amjevita (adalimumab-atto) as a biosimilar to Abbvie product Humira (adalimumab) for multiple inflammatory diseases.

Enbrel and Humira belong to a class of drugs that treating inflammation by blocking a protein known as tumor necrosis factor.

Manufactured by Amgen.

Amjevita is approved for the treatment of :

  • 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.

The most serious known adverse events with Amjevita are infections and malignancies. The most common expected adverse reactions with Amjevita are infections and injection site reactions.

Press release from FDA:

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm522243.htm

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