FDA approves Amgen’s Amnjevita alternative version of AbbVie’s Humira
26 Sep 2016
Federal regulators on Friday approved the first alternative version of the second-best selling drug in the world, Humira, the blockbuster injection used in the treatment of rheumatoid arthritis and other inflammatory diseases.
The Food and Drug Administration (FDA) approved Amgen Inc's Amjevita, near-copy of the drug. The drug has been approved for over a half-dozen conditions listed on the original drug's label, including severe psoriasis and Crohn's diseases.
Humira, manufactured by AbbVie notched sales of $15 billion in 2015 and, it was for many years the top-selling prescription drug in the world, according to data from IMS Health.
It was the fourth time that the FDA had formally approved a so-called biosimilar, a lower-cost version of a biotech drug. Biosimilar drugs, long available in Europe, could generate billions in savings for the US health system according to experts.
However, only one biosimilar, Novartis' Zarxio cleared by the FDA, is available in the market. Zarixo is an alternative to Amgen's Neupogen and sells for about 15 per cent less than the original product. The drug boosts the production of red blood cells in cancer patients.
According to Wall Street analysts, AbbVie claimed it holds patents protecting Humira until at least 2022. They had earlier estimated that Amgen's version could launch sometime between 2018 and 2022, depending on the outcome of court litigation.
Meanwhile, the FDA said in a press release: Amjevita has been 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.
Amjevita is also indicated for moderately to severely active polyarticular juvenile idiopathic arthritis in patients four years of age and older.
Health care professionals should review the prescribing information in the labeling for detailed information about the approved uses.
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