EMA Advisory Committee Recommends Amgen’s Humira Biosimilar
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of an Amgen adalimumab biosimilar, Solymbic, for all available indications. This product is the second biosimilar developed by Amgen to AbbVie’s anti-inflammatory drug, Humira (adalimumab), which is AbbVie’s top-selling drug and is one of the top-selling drugs in the pharmaceutical industry with 2016 global sales of $16 billion.
The CHMP opinion recommends approval of Solymbic for treating certain inflammatory diseases in adults, including moderate-to-severe rheumatoid arthritis (RA), 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 treating certain pediatric 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).
The CHMP positive opinion will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU). If approved, a centralized marketing authorization will be granted that will be valid in the 28 countries that are members of the EU. Norway, Iceland, and Liechtenstein, as members of the European Economic Area, will take corresponding decisions on the basis of the decision of the EC.
Amgen’s first adalimumab biosimilar, Amjevita (adalimumab-atto), was approved in the US in September 2016 by the US Food and Drug Administration (FDA) across all eligible indications of Humira. In the US, Amjevita was approved for treating seven inflammatory diseases, including moderate-to-severe RA, moderate-to-severe polyarticular juvenile idiopathic arthritis, psoriatic arthritis, AS, moderate-to-severe chronic plaque psoriasis, adult moderate-to-severe Crohn’s disease, and moderate-to-severe ulcerative colitis. In Europe, this product also received a positive CHMP opinion in January 2017 under the brand name, Amgevita, recommending approval for treating rheumatoid arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, hidradenitis suppurativa, Crohn’s disease, ulcerative colitis and uveitis.
In addition to Amgen’s two adalimumab biosimilars, Boehringer Ingelheim’s adalimumab biosimilar was accepted for review by the FDA and EMA in January 2017. There are also several other companies developing biosimilar candidates to Humira for various indications and which are in different stages of development, according to a May 2016 analysis by QuintilesIMS. These companies include: Baxalta with partner Momenta Pharmaceuticals (Phase III, psoriasis), Coherus Biosciences (Phase III, psoriasis), Epirus Biopharmaceuticals (discovery stage), Fujifilm Kyowa Kirin Biologics (Phase III, rheumatoid arthritis), Merck KGaA (Phase III, psoriasis), Oncobiologics (Phase I stage), Pfizer (Phase III, rheumatoid arthritis), and Sandoz (Phase III, psoriasis).