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Amgen’s Humira Biosimilar Recommended for EMA Approval

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Biosimilar

If the EMA takes the advice of the CHMP, Amjevita could be approved to treat a number of conditions, including rheumatoid arthritis, psoriatic arthritis, Crohn’s disease and ulcerative colitis.

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February 1, 2017 | by Sarah Hand, M.Sc.

An advisory committee to the European Medicines Agency (EMA) recently recommended the approval of Amgen’s biosimilar of AbbVie’s Humira. The drug was originally submitted for European approval back in late 2015, with the biosimilar – marketed as Amjevita – approved by the US Food and Drug Administration (FDA) in September of 2016.

If the EMA takes the advice of the CHMP, Amjevita could be approved to treat a number of conditions, including rheumatoid arthritis, psoriatic arthritis, Crohn’s disease and ulcerative colitis. According to the committee, “studies have shown that Amgevita has comparable quality, safety and efficacy to Humira.”



In addition to Amjevita, the EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended the approval of seven other drugs. The committee also announced that Sandoz had withdrawn its application for approval of its biosimilar of Amgen's Neulasta.

Neulasta is not Amgen’s top selling product, however biosimilar competition for the biologic could certainly have an effect on sales of the drug. As Novartis’ generic unit, Sandoz, has withdrawn their application for now, Amgen will have more time to plan for the potential launch of the copycat biologic in the future.

However, Novartis has plans to resubmit the Neulasta biosimilar to the EMA in late 2017. The drugmaker also plans to resubmit the drug for approval by the FDA in 2018.


Keywords: Biosimilar, Biologic, EMA


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