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US FDA committee recommends approval for Amgen's biosimilar of AbbVie's Humira

Published on 13/07/16 at 09:08am

One of the world’s bestselling drug may soon have competition in the US markets after the regulators backed a biosimilar copy of the medicine to treat rheumatoid arthritis and inflammatory diseases.

A US Food and Drug Administration committee has voted in favour of recommending approval for ABP 501, Amgen's (Nasdaq: AMGN) proposed biosimilar of AbbVie's (NYSE: ABBV) Humira (adalimumab).

AbbVie’s Humira is cleared as treatment for seven chronic inflammatory diseases including rheumatoid arthritis, psoriatic arthritis, Crohn's disease, ulcerative colitis and plaque psoriasis. The recommendation follows the FDA committee report saying the trial compound ABP 501 was highly similar to Humira.

The panel voted 26-0 in favour of the drug, ABP 501, which was studied in rheumatoid arthritis and plaque psoriasis. The committee said the study results could be applied to other conditions for which Humira is approved, including adult Crohn's disease and ulcerative colitis and should be approved for those conditions as well.

The agency is expected to announce a final decision by September 25.

AbbVie is trying to block Amgen's drug from reaching the market. The company has claimed it has patent protection for Humira in the US until at least 2022.

Humira generated US sales of more than $8 billion in 2015 about 60% of AbbVie’s revenue. The drug was initially approved in 2002 and has been a been among the most profit generating drugs globally.

Meanwhile, a US regulatory committee is also set to vote for Novartis AG's (NYSE: NVS) cheaper version of Amgen's arthritis drug Enbrel.

Enbrel and Humira are a class of drugs that block a protein involved in inflammation known as tumor necrosis factor, or TNF.

Anjali Shukla


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