Amgen, Inc. (NASDAQ:AMGN), a biotech stocks company has announced getting European Commission (EC)’s approval for marketing of its AMGEVITA™ (biosimilar adalimumab1). AMGEVITA has been approved for treatment of inflammatory diseases in adult patients including mild to severe psoriatic arthritis, rheumatoid arthritis, severe axial spondyloarthritis, severe active ankylosing spondylitis (AS), moderate-to-severe hidradenitis suppurativa, posterior and panuveitis, non-infectious intermediate, polyarticular juvenile idiopathic arthritis, enthesitis-related arthritis and severe chronic plaque psoriasis.
Amgen M.D, executive vice president of Research and Development Sean E. Harper says the approval of the company’s first biosimilar is a big milestone for the company and millions of people suffering from chronic inflammatory diseases and who require alternative methods of treatment. He adds that the company has the ability to offer chronic inflammatory diseases patients with an additional option for treatment.
The European Commission approved AMGEVITA after a comprehensive data package which endorsed biosimilarity to adalimumab on grounds of pharmacokinetic, analytical and clinical data including the results from two Phase 3 trials carried out in patients with mild to severe plaque psoriasis as well as patients with mild to severe rheumatoid arthritis. Both Phase 3 studies met their primary endpoints with o clinical differences to adalimumab. AMGEVITA’s immunogenicity and safety were also similar to adalimumab.
The European Commission approval offers marketing and commercialization authorization of the drug with unified labeling in 28 nations that member states of the European Commission. Iceland, Norway and Liechtenstein who are members of the European Economic Area (EEA) are expected to corresponding stands basing on the EC decision.
AMGEVITA got the U.S. Food and Drug Administration’s approval on Sept. 23, 2016. The drug is called AMJEVITA™ (adalimumab-atto) in the U.S.
AMGEVITA has a lot of similarities to adalimumab which is an anti-TNF-α monoclonal antibody. AMGEVITA’s active ingredient is an anti-TNF-α monoclonal antibody with similar amino acid sequence as adalimumab. The drug will be administered using autoinjector presentations and prefilled syringe.
Amgen is a top biotech stocks pharmaceutical company committed to opening the biological potential for patients with serious illness through discovery, development and manufacturing innovative human therapeutics.