Celltrion Healthcare receives positive CHMP opinion for subcutaneous formulation of infliximab, Remsima® SC, for direct use of subcutaneous therapy without IV loading in adults with rheumatoid arthritis

Celltrion Healthcare receives positive CHMP opinion for subcutaneous formulation of infliximab, Remsima^® SC, for direct use of subcutaneous therapy without IV loading in adults with rheumatoid arthritis

• The Committee for Medicinal Products for Human Use (CHMP) recommends that Remsima^® SC can be initiated without IV loading in patients with rheumatoid arthritis (RA)
• The recommended new posology is to start Remsima^® SC 120mg weekly up to week 4 and inject every 2 weeks thereafter; For patients currently on infliximab IV, Remsima^® SC can be administered after 8 weeks from last dose without additional IV loading
• The availability of the subcutaneous induction therapy could potentially shorten drug administration time, reduce healthcare practitioner time, and offer additional flexibility for patients

WEDNESDAY 31 MARCH, 2021 - INCHEON, SOUTH KOREA - Celltrion Healthcare today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended Remsima^® SC for direct use of subcutaneous therapy without IV loading in patients with rheumatoid arthritis (RA).^[i]

As a result of the CHMP opinion, if agreed by European Commission (EC), Remsima^® SC 120 mg can be used without IV infusion both for new and existing RA patients. The recommended posology for newly diagnosed or newly infliximab-initiated patients, suggests that Remsima^® SC should be initiated as a subcutaneous injection at week 0 and additional injections will be given at week 1, 2, 3 and 4 after the first injection. Then, maintenance therapy will be followed every 2 weeks thereafter. For existing patients, Remsima^® SC is administered without additional IV loading 8 weeks after last administration of the infliximab IV.

“IV administration of infliximab requires frequent hospital visits which can pose a challenge to some patients especially given the current COVID-19 pandemic,” said Professor Roberto Caporali, Professor of Rheumatology at the University of Milan and Head of Rheumatology Unit of Gaetano Pini Hospital, Milan Italy. “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.”

Previous pharmacoeconomic model which estimates delivering subcutaneous infliximab with IV induction regimen yields savings of 21 million GBP compared to IV infliximab when treating British RA patients in one-year time frame. Remsima^® SC without IV induction can generate additional saving of 14 million GBP. All models project potential savings from IV administration costs thus societal gain may be greater than the estimates.^[ii]

“Today’s positive CHMP opinion marks a step forward in our goal to provide flexible treatment schedules to patients with rheumatoid arthritis especially under COVID-19 situation,” said Dr. HoUng Kim, Ph.D., Head of Medical and Marketing Division at Celltrion Healthcare. "If the recommendation of EMA is agreed by EC, Remsima^® SC could be used without IV infusion for newly initiated patients as well as patients currently on infliximab treatment.”

[i] Opinion of the committee for medicinal products for human use on a type II variation to the terms of the marketing authorisation | European Medicines Agency (europa.eu). [Last accessed 29 March 2021]

[ii] M. Perry et al. Budget Impact Analysis of Introducing subcutaneous infliximab CT-P13 SC from the UK payer perspective. Abstract presented at EULAR 2020