Amgen files for EU approval of adalimumab biosimilar

Amgen has applied for European regulatory approval of a new biosimilar version of adalimumab, the drug marketed by AbbVie under the brand name Humira.

ABP 501 is a biosimilar candidate to adalimumab, an anti-TNF-alpha monoclonal antibody that has been approved in many countries for the treatment of various inflammatory diseases.

The marketing authorisation application filed with the European Medicines Agency (EMA) is supported by phase III clinical trial data showing its efficacy in the treatment of moderate-to-severe plaque psoriasis and rheumatoid arthritis.

This is the first adalimumab biosimilar application submitted to the EMA and represents Amgen's first biosimilar to be submitted for approval in the EU.

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

Amgen has a total of nine biosimilar therapies in development, including four oncology biosimilars being collaboratively researched with Allergan.