Apr 11, 2017
Europe has approved Amgen for its first ever biosimilar, which is a variant of Humira (adalimumab) an AbbVie’s blockbuster $16.1 billion a year autoimmune disease treatment.
Thereby striking the first ever European license for a biosimilar version of Humira, the European Commission has given approval to Amgevita which is a biosimilar adalimumab in complete obtainable signals of its originator product.
Amgevita is both Amgen’s first biosimilar and now the first Humira biosimilar to be approved in Europe. Amgen said it had acquired all the marketing authorization for “all available indications” for Humira, which also comprised of moderate-to-severe psoriatic arthritis, rheumatoid arthritis, and Crohn’s disease.
Amgen’s executive vice president of research and development, Sean Harper said, "The approval of our first biosimilar by the European Commission is a major milestone not just for Amgen as a company, but for the millions of patients with chronic inflammatory diseases who need alternative treatment options.
"In addition, Amgevita holds the potential to offer patients with chronic inflammatory diseases an additional treatment option. This milestone exemplifies our ongoing dedication to the development of high-quality biologic medicines."
After the advisory board of scientists declared that the biosimilar was extremely alike to Humira, only then the European Commission gave approval to Amgevita. Also, the studies possessed that it had quite a comparable safety, quality and efficiency to its originator.
Amgen stated that the information itpresented to the govern regulators includes outcomes of two phase 3 studies in moderate-to-severe rheumatoid arthritis and moderate-to-severe plaque psoriasis. Both of which matched with their main endpoints, witnessing no clinically meaningful differences to Humira and comparable safety and immune resistance for Amgevita.
Humira was first approved in 2003 and last year made sales of $16.1 billion for AbbVie.
Apr 11, 2017
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