Multiple sources are reporting that Celltrion is planning to roll out REMSIMA SC, its subcutaneous infliximab biosimilar of Johnson & Johnson’s autoimmune disease treatment REMICADE, in Europe in the first quarter of 2020, and specifically is targeting a launch in Germany in March, 2020, with launches in the UK and the Netherlands in the first half of 2020.

We previously reported on the EMA’s approval of REMSIMA SC, in December, 2018.  Subsequently, in September, 2019, the Committee for Medicinal Products for Human Use (CHMP) recommended approval of the subcutaneous method of administration associated with REMSIMA SC.   While intravenous REMSIMA is authorized for psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, psoriasis, Crohn’s disease and rheumatoid arthritis, REMSIMA SC is authorized only for rheumatoid arthritis.