Adalimumab biosimilar given go-ahead in USA and Europe
medwireNews: Adalimumab-adbm, an adalimumab biosimilar, has been approved by the US FDA and has received a positive opinion from the European Medicines Agency (EMA) for the treatment of various rheumatologic conditions.
The biosimilar is available in the USA as a 40 mg injection for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, and ankylosing spondylitis, in addition to other conditions including Crohn’s disease and ulcerative colitis.
This approval was based on the results of studies showing that adalimumab-adbm is highly similar to its reference product, with no clinically meaningful differences in the quality, efficacy, and safety profiles of the two drugs.
The US label for adalimumab-adbm contains a boxed warning for serious infection including tuberculosis, and the FDA cautions that lymphoma and other malignancies have been reported among children and adolescents receiving anti-tumor necrosis factor treatment.
In Europe, the EMA’s Committee for Medicinal Products for Human Use has recommended approval of adalimumab-adbm for similar rheumatologic indications to those approved in the US. The EMA notes that detailed recommendations for the use of the adalimumab biosimilar will be made available following final approval by the European Commission, which is expected in approximately two months’ time.
medwireNews is an independent medical news service provided by Springer Healthcare. © 2017 Springer Healthcare part of the Springer Nature group