Celltrion's Subcutaneous Infliximab Gains EC Nod for 5 Indications

The European Commission (EC) has granted marketing authorization for the first subcutaneous (SC) formulation of infliximab, Remsima SC, for an additional 5 indications, including inflammatory bowel disease and ankylosing spondylitis.

This means the product indications now match all approved indications for the intravenous (IV) formulation in adult patients, including ankylosing spondylitis, Crohn disease (CD), ulcerative colitis (UC), psoriatic arthritis, and psoriasis.

The EC marketing authorization is based on positive findings comparing pharmacokinetics, efficacy and safety of the IV and SC formulations of Remsima in patients with CD and UC.

Based on the results of a 1-year 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.

“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,” said Hyoung-Ki Kim, vice chairman at Celltrion Healthcare, based in Incheon, Republic of Korea.

The approval comes after a positive opinion for Remsima SC from the Committee for Medicinal Products for Human Use of the European Medicines Agency in June.

Kim said the regulatory approval came earlier than expected and followed prioritization of the review by the European Commission.

“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,” said Stefan Schreiber, MD, PhD, director of the Clinic for Internal Medicine at Kiel Campus of the University Hospital Schleswig-Holstein in Germany.