Amgevita, Amgen's Biosimilar Adalimumab, Launches in Europe

Amgen's Amgevita, a biosimilar to adalimumab, has launched in markets across Europe. Amgevita is the first adalimumab biosimilar to be approved by the European Commission (EC) and is authorized for the treatment of inflammatory diseases in adults, including moderate-to-severe rheumatoid arthritis; psoriatic arthritis; severe active ankylosing spondylitis (AS); severe axial spondyloarthritis without radiographic evidence of AS; moderate-to-severe chronic plaque psoriasis; moderate-to-severe hidradenitis suppurativa; non-infectious intermediate, posterior and panuveitis; moderate-to-severe Crohn's disease and moderate-to-severe ulcerative colitis. Amgevita is also authorized for the treatment of pediatric inflammatory diseases, including moderate-to-severe Crohn's disease (ages six and older), severe chronic plaque psoriasis (ages four and older), enthesitis-related arthritis (ages six and older) and polyarticular juvenile idiopathic arthritis (ages two and older).

"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," says David M. Reese, MD, 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."  

The EC approved Amgevita's comprehensive data package supporting biosimilarity to adalimumab based on analytical, pharmacokinetic and clinical data, including results from two Phase 3 confirmatory studies conducted in moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis patients. The Phase 3 studies each met their primary endpoint showing no clinically meaningful differences from adalimumab. Safety and immunogenicity of AMGEVITA were also comparable to adalimumab, and the data included a double-blind randomized switch from adalimumab to Amgevita. Amgevita was also evaluated in a long-term Phase 3 study in moderate-to-severe rheumatoid arthritis patients, which found that efficacy was maintained with no new safety findings. Amgevita is provided in a citrate-free formulation.

"Building on our strong inflammatory disease presence in the United States, we are excited to develop our inflammation capabilities in Europe," said Scott Foraker, vice president and general manager of Biosimilars at Amgen. "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."

Amgen has a total of 10 biosimilars in its portfolio, three of which have been approved by the EC. Amgevita has launched in the 28 countries that are members of the European Union as well as in Norway, Iceland and Liechtenstein, which are members of the European Economic Area.