Amgen submits Marketing Authorization Application for ABP 501 to European Medicines Agency.
+ Technology/Innovation
Jamie Barrand | Dec 5, 2015

Amgen submits Marketing Authorization Application for ABP 501 to European Medicines Agency

Pharmaceutical company Amgen has submitted what company officials believe to be the first Marketing Authorization Application (MAA) to the EU for an adalimumab biosimilar medication. The application, which Amgen forwarded to the European Medicines Agency (EMA), is ABP 501, a medication similar to Humira (adalimumab), an anti-inflammatory medication used to treat rheumatoid arthritis (RA) and other inflammatory diseases.

Amgen's researchers conducted tests on ABP 501 in patients living with moderate to severe plaque psoriasis and RA, which showed ABP 501 acted in a similar manner as adalimumab and produced similar results in patients.

"The submission of Amgen's first biosimilar application to the EMA is an exciting milestone as we seek to expand our global patient reach," Dr. Sean Harper, executive vice president of research and development at Amgen, said. "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."

More information about Amgen and its biosimilars program is online at the company's website.

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics.

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