On Oct. 15, 2018, Amgen announced that Amgevita (biosimilar adalimumab), a biosimilar to AbbVie’s Humira (adalimumab), will launch in markets across Europe beginning on Oct. 16, 2018. Humira is AbbVie’s highest revenue-grossing product with $18.4 billion in 2017 sales.
Amgevita is a fully human immunoglobulin G1 monoclonal antibody that binds and neutralizes human tumor necrosis factor alpha (TNFα), a cytokine which mediates the inflammatory response. The drug’s amino acid sequence is identical to that of the reference product, adalimumab. Amgevita will be available in a prefilled syringe and pre-filled pen (SureClick autoinjector) to support dosing according to the approved dosage recommendations in each indication.
According to Amgen, Amgevita is the first adalimumab biosimilar to be approved by the European Commission (EC). The drug 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. The drug 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,” said David M. Reese, MD, executive vice president of Research and Development at Amgen, in a company press release. “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 data package supporting biosimilarity to adalimumab based on analytical, pharmacokinetic, and clinical data, including results from two Phase III confirmatory studies conducted in moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis patients. The Phase III studies each met their primary endpoint showing no clinically meaningful differences from adalimumab.
Amgen has a total of 10 biosimilars in its portfolio, three of which have been approved by the EC. Amgevita will launch 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.
“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, in the release. “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.”
The launch of Amgen’s adalimumab in Europe follows an Oct. 11, 2018 announcement from Sandoz that a global resolution of all intellectual property (IP)-related litigation with AbbVie concerning Sandoz’s proposed biosimilar, Hyrimoz (adalimumab), to AbbVie’s Humira (adalimumab) was met. The resolution paves way for a 2018 launch of Sandoz’s product in key European markets and secures United States market entry, which is planned in 2023, Sandoz reports.