European Commission expands approved indications for subcutaneous infliximab biosimilar
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The European Commission has extended approval for Celltrion Healthcare’s subcutaneous infliximab biosimilar to treat adults with ankylosing spondylitis, Crohn’s disease, ulcerative colitis, psoriatic arthritis and psoriasis.
Approved in 2019 for the treatment of DMARD-refractory rheumatoid arthritis, the subcutaneous version of Remsima (infliximab-dyyb, Celltrion) is intended to provide a more consistent drug exposure between patients as well as more convenient administration. With this approval, the subcutaneous formulation now matches all approved indications for the intravenous formulation in adult patients.
“We are pleased to announce this important regulatory milestone earlier than we expected, with the European Commission prioritizing review of this important new administration option,” Hyoung-Ki Kim, vice chairman at Celltrion, said in a press release. “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.”
He added, “We will do our best to make Remsima SC available as early as possible and hope this medication will contribute to minimizing the risks involved with administering medical treatments during the COVID-19 pandemic.”
The European Commission based its approval, in part, on data presented at the 2020 annual congress of the European Crohn’s and Colitis Organization, evaluating the efficacy, pharmacokinetics and overall safety of the SC vs. intravenous formulations of Remsima in patients with active Crohn’s disease and ulcerative colitis.
According to study results, the SC formulation of Remsima demonstrated comparable efficacy and safety outcomes to the IV formulation throughout the 1-year treatment period. Based on these results, the European Commission has approved a 120 mg fixed dose of Remsima SC for use in adults regardless of body weight, in both existing and newly added indications.
“The subcutaneous formulation of Remsima has been shown to have very high efficacy, and favorable data, which are fully comparable to the efficacy and safety profile of the IV formulation,” Stefan Schreiber, MD, PhD, director of the Clinic for Internal Medicine at Kiel Campus of the University Hospital Schleswig-Holstein in Germany, said in a press release. “Today’s approval marks an important progress for the gastroenterology community as it means that treatment can now be administered in significantly less time, thereby providing patients more flexibility and control over how they receive their treatment.”
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