First subcutaneous infliximab recommended for approval by EMA committee
The European Medicines Agency’s human medicines committee has recommended approval of the first subcutaneous version of biosimilar infliximab.
If the change to the terms of the marketing authorisation is approved by the European Commission, Remsima — manufactured by Celltrion Healthcare Hungary Kft — will be available as a 120mg solution for use in prefilled pens or syringes alongside the existing 100mg powder for concentrate for solution for infusion.
The positive recommendation was adopted by the Committee for Medicines Products for Human Use (CHMP) at its meeting held between 16–19 September 2019.
Remsima for subcutaneous use, in combination with methotrexate, is indicated for the reduction of signs and symptoms and improvement in physical function in adult patients with rheumatoid arthritis (RA).
The recommendation was based on the phase I/III study to evaluate the pharmacokinetics, efficacy and safety between the subcutaneous infliximab and the well-established intravenous version in people with active RA. The efficacy and safety profile of the two administrations was found to be comparable.
Rene Westhovens, a rheumatologist at the University Hospitals KU Leuven in Belgium, described the recommendation as “encouraging”.
“This new [subcutaneous] formulation of infliximab could give patients the opportunity to administer the treatment themselves as an injection, giving them more control over their own treatment.”
At the same meeting, the CHMP recommended seven medicines for approval including metformin hydrochloride/saxagliptin/dapagliflozin (Qtrilmet; AstraZeneca AB) modified release tablets for the treatment of type 2 diabetes mellitus, and netarsudil (Rhokiinsa, Aerie Pharmaceuticals Ireland) 200 microgram/ml eye drops for the treatment of patients with glaucoma or ocular hypertension.
Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2019.20207098
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