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Amgen applies for approval of biosimilar to adalimumab in Europe

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Amgen announced it has applied to the European Medicines Agency for ABP501, a biosimilar to the tumor necrosis factor-alpha inhibitor Humira (adalimumab).

According to the release, the submission includes data from trials of patients with moderate-to-severe rheumatoid arthritis and moderate-to-severe plaque psoriasis.

“The submission of Amgen’s first biosimilar application to the [European Medicines Agency] EMA is an exciting milestone as we seek to expand our global patient reach,” Sean E. Harper, MD, executive vice president of Research and Development at Amgen, said in a press release. “Patients with chronic inflammatory conditions are faced with a significant burden of disease requiring long-term treatment. Amgen’s branded biologic medicines and biosimilars are developed and manufactured according to the same high standards, and we are committed to delivering medicines to patients worldwide.”

Reference:

www.amgen.com