Celltrion’s infliximab biosimilar Remsima secures European approval in five indications
pharmafile | July 27, 2020 | News story | Manufacturing and Production, Sales and Marketing | celltrion, infliximab, pharma, remsima
The subcutaneous (SC) formulation of Remsima, Celltrion’s biosimilar version of infliximab, has secured approval from the European Commission covering five indications, according to the company, including ankylosing spondylitis, Crohn’s disease, ulcerative colitis, psoriatic arthritis and psoriasis.
The approval means that Remsima SC will be available in 120mg doses to adult patients for the treatment of one of the above conditions, regardless of their body weight.
The decision was made off the back of one-year clinical data comparing the SC formulation to the intravenous formulation of the drug in active Crohn’s disease and ulcerative colitis. The drug has “shown to have very high efficacy, and favourable data, which are fully comparable to the efficacy and safety profile of the IV formulation,” according to Professor Stefan Schreiber, Director of the Clinic for Internal Medicine at Kiel Campus of the University Hospital Schleswig-Holstein in Germany.
The therapy chalked up a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in June.
“We are pleased to announce this important regulatory milestone earlier than we expected, with the European Commission prioritising review of this important new administration option. We will accelerate the launch process on a country-by-country basis in order to expand treatment options for patients with chronic inflammatory diseases such as inflammatory bowel disease and ankylosing spondylitis,” commented Hyoung-Ki Kim, Vice Chairman at Celltrion Healthcare. “We will do our best to make Remsima SC available as early as possible and hope this medication will contribute to minimising the risks involved with administering medical treatments during the COVID-19 pandemic.”
Matt Fellows
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