According to Amgen, Inc. (NASDAQ:AMGN), Amgevita has received marketing approval in all its available indications. Some of the diseases that Amgevita is used as a treatment include particular inflammatory diseases that occur in adults, psoriatic arthritis, rheumatoid arthritis, axial spondyloarthritis, active ankylosing spondylitis, hidradenitis suppurativa, chronic plaque psoriasis, and panuveitis, Crohn’s disease, and ulcerative colitis.

Pediatric inflammatory diseases

Other diseases that Amgevita received approval for include particular pediatric inflammatory diseases such as Crohn’s disease in children between the ages of six years and above, chronic plaque psoriasis in children aged between four years and above, polyarticular juvenile idiopathic arthritis in children aged between two years and above as well as enthesitis-related arthritis in children aged between six years and over.

“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,” said Sean Harper, Amgen’s Research and Development executive vice president.

Approval of Amgevita by the European Commission came after thoroughly analyzing comprehensive data that supported the biosimilarity of the drug to adalimumab. Most of the data was collected from third phase studies that were conducted in patients who were suffering from rheumatoid arthritis and plaque psoriasis. Primary endpoints were reached in each of the phase 3 studies as there weren’t any significant differences that were observed between Amgevita and its biosimilar. Amgevita also showed similar immunogenicity and safety levels to adalimumab.

Bigger market

With the approval from the European Commission, Amgevita can now be marketed in 28 states that comprise the European Union. In each of those markets the drug will bear unified labelling. Also, for countries such as Liechtenstein, Iceland and Norwway, which belong to the EEA – European Economic Area, decisions on Amgevita will also correspond to those of the European Commission.

In the United States, Amgevita received the approval of the Food and Drug Administration last year in September and it is sold under a different brand name – Amjevita.

On Thursday shares of Amgen Inc fell by 0.84% to close the day at $166.04.