The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has given a positive opinion, recommending that biosimilar Imraldi be granted marketing authorisation.
Positive opinion
Imraldi, a biosimilar agent from Samsung Bioepis, is highly similar to the reference product Humira (adalimumab) with data demonstrating comparable quality, safety and efficacy of the product to the reference therapy, as stated in a release from the EMA. It will be available as a 40 mg solution for injection and is indicated for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, paediatric plaque psoriasis, hidradenitis suppurativa, Crohn’s disease, paediatric Crohn’s disease, ulcerative colitis and uveitis.
“We welcome the EMA’s positive recommendation for Imraldi, which brings us a step closer to delivering a lower-cost, high-quality autoimmune treatment option to patients across Europe,” said Christopher Hansung Ko, president & CEO of Samsung Bioepis, in a press release. “Through relentless process innovation and an uncompromising commitment to quality, we remain dedicated to advancing one of the industry's strongest biosimilar pipelines, so that more patients and healthcare systems across Europe will benefit from biosimilars.”
This positive opinion has been submitted for review by the European Commission. If marketing authorisation is granted, the product will be commercialised in the EU by Biogen.