Amgen launches first biosimilar of best-selling Humira in Europe

Amgevita, as the biosimilar is known, is the first such version of the world’s best-selling drug to secure approval from the European Commission, and as such is authorised for use in all the indications of its reference product, including moderate-to-severe rheumatoid arthritis; psoriatic arthritis; severe active ankylosing spondylitis (AS); moderate-to-severe chronic plaque psoriasis; moderate-to-severe Crohn's disease; moderate-to-severe ulcerative colitis, and more.

It is also approved for use in paediatric patients in a number of conditions, including moderate-to-severe Crohn's disease, severe chronic plaque psoriasis, enthesitis-related arthritis and polyarticular juvenile idiopathic arthritis.

Amgen secured approval for the therapy based on three Phase 3 trials which confirmed its biosimilarity to Humira with regards to safety and efficacy, showing no clinically meaningful differences between the two products.

"The launch of Amgevita in Europe is an important milestone for our biosimilars portfolio, expanding the range of treatment options for the millions of patients living with chronic inflammatory diseases," said Dr David M Reese, Executive Vice President of Research and Development at Amgen. "Amgevita is Amgen's second biosimilar to launch in Europe, demonstrating our commitment to providing patients with serious illnesses access to high-quality biological therapies."   

Scott Foraker, the company’s Vice President and General Manager of Biosimilars, added: "Building on our strong inflammatory disease presence in the United States, we are excited to develop our inflammation capabilities in Europe. As the first inflammation biosimilar from our portfolio to launch in Europe, Amgevita will extend our reach and help more patients gain access to this important class of therapies."