Amgen Secures Approval for Two Humira Biosimilars in the EU through Duplicate MAAs
The European Commission granted Amgen approvals for two Humira biosimilars — Amgevita and Solymbic — under a duplicate application process in the EU.
The biosimilars are approved for the same indications as Humira, including certain inflammatory diseases in adults, including rheumatoid arthritis; psoriatic arthritis; active ankylosing spondylitis; severe axial spondyloarthritis; chronic plaque psoriasis; moderate-to-severe hidradenitis suppurativa; non-infectious intermediate, posterior and panuveitis; Crohn’s disease; and ulcerative colitis.
It has also been approved for the treatment of certain pediatric inflammatory diseases, including 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 FDA approved Amgen’s Humira biosimilar as Amjevita in September 2016.