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 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).¹

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.²

"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."

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Notes to Editors:

About Remsima^® (CT-P13) intravenous (IV) formulation¹
Remsima^® IV is usually given as 3 mg per kg/body weight in rheumatoid arthritis (RA) and as 5 mg per kg/body weight for the other indications. Infliximab IV is given as an infusion over two hours. All patients are monitored for any reactions during the infusion and for at least one to two hours afterwards.

About Remsima^® CT-P13 subcutaneous (SC) formulation^3,4
A 120 mg fixed dose of Remsima^® SC has been granted marketing authorisation in the EU, in adults regardless of body weight, in all previously approved indications for the IV formulation. Remsima^® SC has three administration options; via a pre-filled pen (auto injector), pre-filled syringe or pre-filled syringe with needle safeguard. The SC formulation has the potential to enhance treatment options for the use of infliximab biosimilar by providing high consistency in drug exposure and a convenient method of administration.

About CT-P13 (biosimilar infliximab)
CT-P13 is developed and manufactured by Celltrion, Inc. and was the world's first monoclonal antibody biosimilar approved by the European Commission (EC). It is indicated for the treatment of eight autoimmune diseases including RA and IBD. It was approved by the EC under the trade name Remsima^® in September 2013 and launched in major EU countries in early 2015. The US FDA approved CT-P13 in April 2016 under the trade name Inflectra®. CT-P13 is approved in more than 96 countries (as of March 2021) including the US, Canada, Japan and throughout Europe.

About Celltrion Healthcare
Celltrion Healthcare is committed to delivering innovative and affordable medications to promote patients' access to advanced therapies. Its products are manufactured at state-of-the-art mammalian cell culture facilities, designed and built to comply with the US FDA cGMP and the EU GMP guidelines. Celltrion Healthcare endeavours to offer high-quality cost-effective solutions through an extensive global network that spans more than 110 different countries. For more information please visit: https://www.celltrionhealthcare.com/en-us

References

¹ 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]
² M. Perry et al. Budget Impact Analysis of Introducing subcutaneous infliximab CT-P13 SC from the UK payer perspective. Abstract presented at EULAR 2020
³ Yoo DH, Jaworski J, Matyska-Piekarska E et al. A Novel Formulation of CT-P13 (infliximab biosimilar) for subcutaneous administration: One-year results from part one of a Phase I/III randomised controlled trial in patients with rheumatoid arthritis. Poster (FRI0128). Presented at EULAR 2019.
⁴ Westhovens R, Wiland P, Zawadzki M et al. A novel formulation of CT-P13 (infliximab biosimilar) for subcutaneous administration: 30-week results from part two of a Phase I/III randomised controlled trial in patients with rheumatoid arthritis. Poster (SAT0170). Presented at EULAR 2019.