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Trials & Filings

Amgen Submits First Biosimilar MAA in EU

ABP 501, a biosimilar candidate to AbbVie’s Humira meets Phase III endpoints

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By: Kristin Brooks

Managing Editor, Contract Pharma

Amgen has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for ABP 501, a biosimilar candidate to AbbVie’s Humira (adalimumab). Amgen believes this is the first adalimumab biosimilar application submitted to the EMA and represents its first biosimilar submitted for approval in the EU.

Adalimumab is an anti-TNF-α monoclonal antibody approved in many countries for the treatment of various inflammatory diseases.

Amgen’s MAA submission includes analytical, clinical and pharmacokinetic data from Phase III comparative efficacy and safety studies conducted in both moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis. The Phase III studies met their primary endpoints showing clinical equivalence to adalimumab. Safety and immunogenicity of ABP 501 were also comparable in both studies. Data to support the transition of adalimumab patients to ABP 501 are included in the submission.

“The submission of Amgen’s first biosimilar application to the EMA is an exciting milestone as we seek to expand our global patient reach,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “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.”

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