The European Commission has granted marketing authorisation to Celltrions Remsima(infliximab, CT-P13) subcutaneous formulation.

The EuropeanCommission (EC) has granted marketing authorisation for the Remsima(infliximab, CT-P13) subcutaneous formulation for the treatment of adult patients with ankylosing spondylitis, Crohns disease, ulcerative colitis, psoriatic arthritis and psoriasis.

Granted to Celltrion Healthcare, the approval follows a positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) of theEuropeanMedicines Agency (EMA)in June and is based on data from a pivotal study comparing the pharmacokinetics, efficacy and safety of the subcutaneous and intravenous (IV) formulations ofRemsimain people with active Crohns disease and ulcerative colitis, throughout a one year treatment period.

Based on the results of the pivotal study, a 120mg fixed dose of Remsima subcutaneoushas been approved for usein theEU inadults regardless of body weight,inboth existing and newly addedindications.

We are pleased to announce this important regulatory milestone earlier than we expected, with theECprioritising review of this important new administration option. We will accelerate the launch process on a country-by-country basisinorder to expand treatment options for patients with chronicinflammatory diseases such asinflammatory bowel disease and ankylosing spondylitis, said Hyoung-Ki Kim, Vice Chairman at Celltrion Healthcare. We will do our best to makeRemsima subcutaneous available as early as possible and hope this medication will contribute to minimising the risksinvolved with administering medical treatments during the COVID-19 pandemic.

According to the company, Celltrion anticipates receiving approval of Remsima subcutaneousin97 countries,including 31 countriesinEurope.

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EC approves subcutaneous formulation of Remsima - European Pharmaceutical Review