Therapy Areas: Autoimmune
European Commission Grants Marketing Authorisation for World's First Subcutaneous Formulation of Infliximab, Remsima SC, for an Additional Five Indications
29 July 2020 - - The European Commission has granted marketing authorisation for Remsima (infliximab, CT-P13) subcutaneous formulation for the treatment of adult patients with ankylosing spondylitis, Crohn's disease, ulcerative colitis, psoriatic arthritis and psoriasis, South Korea-based Celltrion Healthcare said.

The approval follows a positive opinion issued by the Committee for Medicinal Products for Human Use of the European Medicines Agency in June and is based on data from a pivotal study comparing the pharmacokinetics, efficacy and safety of the SC and intravenous formulations of Remsima in people with active Crohn's disease and ulcerative colitis, throughout a one-year treatment period.

Based on the results of the pivotal study, a 120 mg fixed dose of Remsima SC has been approved for use in the European Union, in adults regardless of body weight, in both existing and newly added indications.

Celltrion anticipates receiving approval of Remsima SC in 97 countries, including 31 countries in Europe.

Remsima IV is usually given as 3 mg per kg/body weight in rheumatoid arthritis and as 5 mg per kg/body weight for the other indications. Infliximab IV is given as an infusion over two hours.

All patients are monitored for any reactions during the infusion and for at least one to two hours afterwards.

A 120 mg fixed dose of Remsima SC has been granted marketing authorisation in the EU, in adults regardless of body weight, in all previously approved indications for the IV formulation.

Remsima SC has three administration options; via a pre-filled pen (auto injector), pre-filled syringe or pre-filled syringe with needle safeguard.

The SC formulation has the potential to enhance treatment options for the use of infliximab biosimilar by providing high consistency in drug exposure and a convenient method of administration.

CT-P13 is developed and manufactured by Celltrion, Inc. and was the world's first monoclonal antibody biosimilar approved by the European Commission.

It is indicated for the treatment of eight autoimmune diseases including RA and IBD. It was approved by the EC under the trade name Remsima in September 2013 and launched in major EU countries in early 2015.

The US FDA approved CT-P13 in April 2016 under the trade name Inflectra. CT-P13 is approved in more than 94 countries (as of July 2020) including the US, Canada, Japan and throughout Europe.

Celltrion Healthcare is committed to delivering innovative and affordable medications to promote patients' access to advanced therapies.

Its products are manufactured at mammalian cell culture facilities, designed and built to comply with the US FDA cGMP and the EU GMP guidelines. Celltrion Healthcare endeavours to offer cost-effective solutions through an extensive global network that spans more than 110 different countries.
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