Posted by Michael Wonder on 30 Jan 2017
Amgen receives positive CHMP opinion for ABP 501 (biosimilar adalimumab) for the treatment of certain inflammatory diseases
27 January 2017 - First adalimumab biosimilar candidate recommended for EMA approval.
Amgen today announced that the CHMP of the EMA has adopted a positive opinion for the marketing authorisation of ABP 501 (biosimilar adalimumab), recommending approval for all available indications.
ABP 501 has been recommended for approval for the treatment of certain inflammatory diseases in adults, including moderate-to-severe rheumatoid arthritis, psoriatic arthritis, severe 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 CHMP opinion also recommends approval for the treatment of certain paediatric 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).
