Amgen Submits European Application for Biosimilar Candidate to Humira

On December 4th, Amgen submitted a Marketing Authorization Application to the EMA for a biosimilar candidate (ABP 501) to Humira (adalimumab). Adalimumab is an anti-TNF-α human monoclonal antibody (the first approved by FDA) and is used to treat disorders such as rheumatoid arthritis and Crohn’s disease. This is Amgen’s first biosimilar candidate for approval in the European Union, and Amgen believes ABP 501 is the first biosimilar candidate to adalimumab to be submitted to the EMA.

The submission contains data from Phase 3 studies, which Amgen says shows clinical equivalence to adaliumumab in moderate to severe plaque psoriasis and moderate to severe rheumatoid arthritis.

Stay tuned to Big Molecule Watch for further developments.