Amgen begins rolling out Humira biosimilar in the EU

Amgen begins rolling out Humira biosimilar in the EU - PharmaTimes

Amgevita won European approval back in March 2017 for all indications of its reference product, but Amgen was unable to launch its drug because of a legal battle with AbbVie.

This was settled in September last year, paving the way for a 2018 launch of Amgevita in Europe, and a 2023 launch in the US.

Under terms of the deal, AbbVie granted patent licenses for the use and sale of Amgevita/Amjevita worldwide, on a country-by-country basis.

"The launch of Amgevita in Europe is an important milestone for our biosimilars portfolio, expanding the range of treatment options for the millions of patients living with chronic inflammatory diseases," said David Reese, executive vice president of Research and Development at Amgen.

"Amgevita is Amgen’s second biosimilar to launch in Europe, demonstrating our commitment to providing patients with serious illnesses access to high-quality biological therapies."

Humira, an anti-TNF monoclonal antibody, pulls in annual sales of nearly $15 billion across its range of indications for inflammatory diseases. Biosimilar versions are expected to be significantly cheaper, and thus have the potential to generate substantial savings for healthcare providers.

Since the approval of Amgevita, European regulators have also issued licenses for Samsung Bioepis' Imraldi, Mylan and Fujifilm Kyowa Kirin Biologics' Hulio and Sandoz’ Hyrimoz.

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