EU backs fully subcutaneous regimen of Remicade biobetter

Celltrion
Jung Jin Seo, chairman of Celltrion (Celltrion)

The European Medicines Agency (EMA) has backed the use of Celltrion Healthcare’s subcutaneous infliximab without initial intravenous loading doses. Securing the regulatory recommendation boosts Celltrion’s efforts to outcompete Johnson & Johnson’s Remicade and its biosimilar rivals.

Celltrion received approval for a subcutaneous formulation of infliximab, branded Remsima SC, in the EU in 2019. The formulation is part of Celltrion’s work to develop biobetters, drugs that have the same active ingredient as an off-patent biologic but improve on the originator product in some way. 

The original authorization permitted the use of subcutaneous infliximab after loading doses with the intravenous product. Now, the EMA’s Committee for Medicinal Products for Human Use has come out in favor of starting adult rheumatoid arthritis patients on the subcutaneous formulation.

Under the proposed regimen, patients will take weekly subcutaneous doses of Remsima SC for four weeks. Beyond that, patients will take Remsima SC every two weeks. The regimen eliminates some of the burdens associated with intravenous formulation.

“IV administration of infliximab requires frequent hospital visits which can pose a challenge to some patients,” Roberto Caporali, a University of Milan professor, said in a statement. “The direct subcutaneous induction of the SC formulation of infliximab could potentially shorten drug administration time via self-administration at home, reduce healthcare practitioner time and burden on healthcare system, as well as offering additional flexibility and convenience for patients.”

Pharmacoeconomic modeling suggests switching all British rheumatoid arthritis patients to the fully subcutaneous regimen could generate annual savings of £14 million ($19 million). The savings are on top of an estimated £21 million saved by switching from the fully intravenous to partly subcutaneous regumens.   

The pandemic means healthcare systems may currently be particularly keen to spare patients from the need to visit facilities to receive intravenous doses. Early in the crisis, two U.K. hospital trusts switched their inflammatory bowel disease patients from intravenous to subcutaneous infliximab. All bar three of the 163 patients stayed on the subcutaneous formulation.