European Commission grants marketing authorisation for world’s first subcutaneous formulation of infliximab, Remsima® SC, for an additional five indications including for use in inflammatory bowel disease and ankylosing spondylitis

• The European Union (EU) marketing authorisation for the subcutaneous (SC) formulation of Remsima^® (CT-P13) now applies to all previously approved indications for the intravenous (IV) formulation in adult patients including: ankylosing spondylitis (AS), Crohn’s disease (CD), ulcerative colitis (UC), psoriatic arthritis (PsA) and psoriasis (PsO)
• The EU marketing authorisation is based on pivotal data comparing the pharmacokinetics, efficacy and safety of the IV and SC formulations of Remsima^® in people with active CD and UC
• Celltrion’s Remsima^® SC is the first and only infliximab to have both IV and SC formulations; Remsima^® SC reduces treatment time to approximately 2-5 minutes, with a comparable efficacy and safety profile to the IV formulation of Remsima^®

[July 27^th 2020] - INCHEON, SOUTH KOREA – Celltrion Healthcare today announced that the European Commission (EC) has granted marketing authorisation for Remsima^® (infliximab, CT-P13) subcutaneous (SC) formulation for the treatment of adult patients with ankylosing spondylitis, Crohn’s disease, ulcerative colitis, psoriatic arthritis and psoriasis.^[i]

The approval follows a positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in June and is based on data from a pivotal study comparing the pharmacokinetics, efficacy and safety of the SC and intravenous (IV) formulations of Remsima^® in people with active Crohn’s disease and ulcerative colitis, throughout a 1-year treatment period.^[ii],[iii] 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 (EU), in adults regardless of body weight, in both existing and newly added indications.

Professor Stefan Schreiber, Director of the Clinic for Internal Medicine at Kiel Campus of the University Hospital Schleswig-Holstein in Germany said: “The subcutaneous formulation of Remsima^® (Remsima^® SC) has been shown to have very high efficacy, and favourable data, which are fully comparable to the efficacy and safety profile of the IV formulation. 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.”

“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,” said 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.”

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

[i] European Medicines Agency Summary of Product Characteristics (SmPC). Remsima.

[ii] Reinisch W, et al. A novel formulation of CT-P13 (infliximab biosimilar) for subcutaneous administration: 1-year result from a Phase 1 open-label randomised controlled trial in patients with active Crohn’s disease. European Crohn’s and Colitis Organisation 2019. Abstract no: A-1103.

[iii] Ben-Horin S, et al. A novel subcutaneous infliximab (CT-P13): 1-year results including switching results from intravenous infliximab (CT-P13) in patients with active Crohn’s disease and ulcerative colitis. Oral presentation (OP24). Presented at ECCO 2020.