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FDA verdict on Amgen's Humira biosimilar due in September

Begins review the version of AbbVie's big-selling anti-inflammatory drug

FDA headquartersThe US FDA has started its review of Amgen's biosimilar version of big-selling anti-inflammatory drug Humira, with an action date of September 25.

Amgen filed its biologics license application (BLA) for the biosimilar, called ABP-501, on November 25 based on a clinical data package supporting the drug's equivalence to AbbVie's Humira (adalimumab) in moderate-to-severe plaque psoriasis and rheumatoid arthritis.

In addition to RA and psoriasis, Humira is also licensed to treat psoriatic arthritis and ankylosing spondylitis.

Tumour necrosis factor (TNF) inhibitor Humira was the biggest-selling pharmaceutical in the world in 2014, with revenues of $13bn, and the drug accounts for 60% of AbbVie's revenues. However it is also facing patent expiration at the end of 2016 in the US and in 2018 across Europe.

Sean Harper, Amgen's executive vice president of R&D, said: "If approved, we believe ABP 501 could serve as an important additional approved therapeutic option for patients with chronic inflammatory conditions."

The active ingredient of ABP 501 is an anti-TNF monoclonal antibody that has the same amino acid sequence as adalimumab, said Amgen, which expects to launch its first biosimilar products next year.

At the end of last year, patients in India were the first to receive a Humira biosimilar launched by Indian company Zydus Cadila. Meanwhile, other companies developing biosimilar versions of Humira include Samsung Bioepis - the joint venture between Samsung and Biogen - as well as Novartis' Sandoz unit and Boehringer Ingelheim.

Amgen's biosimilar pipeline also include a version of Roche's breast and gastric cancer therapy Herceptin (trastuzumab) and Avastin (bevacizumab), used in several solid tumour types including colorectal and non-small cell lung cancer (NSCLC). These are both in phase III testing.

It also has biosimilars of Roche's arthritis and haematological cancer therapy MabThera/Rituxan (rituximab), Janssen Biotech's anti-TNF drug Remicade (infliximab) and Eli Lilly's colorectal/head and neck cancer therapy Erbitux (cetuximab) in earlier-stage trials, as well as three other undisclosed projects.

Article by
Phil Taylor

26th January 2016

From: Regulatory

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