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Celltrion Healthcare receives EU marketing authorisation for world’s first subcutaneous formulation of infliximab, Remsima SC™, for the treatment of p
등록일2019-11-26


Celltrion Healthcare receives EU marketing authorisation forworld’s first subcutaneous formulation of infliximab, Remsima SC™, for thetreatment of people with rheumatoid arthritis


·       Remsima SC™ is thesubcutaneous version of Celltrion Healthcare’s infliximab biosimilar, CT-P13

·       European Union (EU) marketingapproval is based on the phase I/III study to evaluate pharmacokinetics,efficacy and safety between CT-P13 SC and the intravenous (IV) version ofCT-P13 in people with active rheumatoid arthritis (RA)

·       Thisnovel formulation provides analternative administration option for European physicians and their patients

November25, 2019 07:43 PM Eastern Standard Time INCHEON,SOUTH KOREA

Celltrion Healthcare todayannounced that the European Commission has approved Remsima SC(CT-P13 SC, biosimilar infliximab) for patients with RA.[1] Remsima SCis the world’sfirst subcutaneous formulation of infliximab.

Remsima SC™ is approved in theEU for the treatment of people with rheumatoid arthritis in combination withmethotrexate (MTX), in adult patients with active RA when the response todisease-modifying anti-rheumatic drugs (DMARDs), including MTX, has beeninadequate; and in adult patients with severe, active and progressive diseasenot previously treated with MTX or other DMARDs.1

The approval is based onclinical evidence including results from a study that showed switching people withRA from the intravenous (IV) formulation to the subcutaneous (SC) formulationof CT-P13 treatment at Week 30 was comparable to maintaining CT-P13 SC up toWeek 54 (up to Week 64 for safety profile).[2] The study was presented atthis year’s American College of Rheumatology Congress.

“The approval of Remsima SC™in Europe gives patients the opportunity to administer the treatment themselvesas an injection, giving them more control over their own treatment”, said ProfessorRene Westhovens, Rheumatologist at the University Hospitals KU Leuven, Belgium.“Remsima SC™ has been shown to have a stable potency, and patients with RA on RemsimaSC™ develop fewer anti-drug antibodies - which can improve the effectiveness ofa treatment - compared with those on CT-P13 IV”.

With the availability of thenovel formulation of infliximab, patients could now be treated with a more personalizedand convenient treatment option. Remsima SC™ can be injected by patientsthemselves, which has the potential to significantly reduce hospital visits, aswell as save time normally required for hospital-administered IV treatment.

Celltrion has also submitted afurther variation to the marketing authorization of Remsima SC™ to extend theindication to inflammatory bowel disease and the approval decision is expected inmid-2020.

“The development of Remsima SC™demonstrates that Celltrion Healthcare is not just a biosimilar company, it isalso an innovative company that strives for novel solutions such as the SCformulation of biosimilar infliximab. We develop cost-effective and patient-centeredtreatments to enable more patients to gain access to biologics that have provenefficacy and safety profiles,” said Hyoung-KiKim, Vice Chairman at Celltrion Healthcare. “Celltrion Healthcare has expandedits business operations to strengthen the company’s presence in the majorEuropean markets. Celltrion expects to launch Remsima SC™ across Europe in the first quarter of 2020”.

Celltrion has applied forpatent protection, until 2038, for Remsima SC™ in approximately 100 countries throughoutthe US, Europe and Asia.

-- ENDS --

Notes to Editors:

About CT-P13 (biosimilar infliximab)1,[3],[4],[5]
CT-P13 is developed and manufactured by Celltrion, Inc. and was the world’sfirst monoclonal antibody biosimilar approved by the European Commission (EC).It is indicated for the treatment of eight autoimmune diseases including RA andIBD. It was approved by the EC under the trade name Remsima® inSeptember 2013 and launched in major EU countries in early 2015. The U.S. Foodand Drug Administration approved CT-P13 in April 2016 under the trade nameInflectra®. CT-P13 is approved in more than 89 countries (as of November2019) including the US, Canada, Japan and throughout Europe.

CT-P13 IV is usually given as 3mg per kg/body weight in RAand as 5mg per kg/body weight for the other indications. Infliximab IV is givenas an infusion over two hours. All patients are monitored for any reactionsduring the infusion and for at least one to two hours afterwards. Celltrion hasalso developed a subcutaneous (SC) formulation of infliximab that has threeadministration options; via a pre-filled pen (auto injector), pre-filledsyringe or pre-filled syringe with needle safeguard. The SC formulation has thepotential to enhance treatment options for the use of infliximab biosimilar byproviding high consistency in drug exposure and a convenient method ofadministration.

CT-P13 SC has received a positive opinion from theCommittee for Medicinal Products for Human Use (CHMP) and EU marketingauthorisation for the treatment of people with RA. A phase III study of CT-P13SC for people with inflammatory bowel disease (IBD) is underway. Celltrion hassubmitted a further variation to the marketing authorization of CT-P13 SC toextend the indication to inflammatory bowel disease.

About Celltrion Healthcare
Celltrion Healthcare is committed to delivering innovative and affordablemedications to promote patients’ access to advanced therapies. Its products aremanufactured at state-of-the-art mammalian cell culture facilities, designedand built to comply with the US FDA cGMP and the EU GMP guidelines. CelltrionHealthcare endeavours to offer high-quality cost-effective solutions through anextensive global network that spans more than 120 different countries. For moreinformation please visit: 
https://www.celltrionhealthcare.com/en-us

References



[1] European Medicines AgencySummary of Product Characteristics (SmPC). Remsima SC™.

[2] Westhovens R, Wiland P,Zawadzki M et al. Efficacy and Safetyof a Novel Subcutaneous Formulation of CT-P13 over the 1-year Treatment Periodand After Switching from Intravenous CT-P13 in Patients with Active RheumatoidArthritis: Results from Part 2 of Phase I/III Randomized Controlled Trial[abstract]. Arthritis Rheumatol. 2019; 71 (suppl 10).Available at:https://acrabstracts.org/abstract/efficacy-and-safety-of-a-novel-subcutaneous-formulation-of-ct-p13-over-the-1-year-treatment-period-and-after-switching-from-intravenous-ct-p13-in-patients-with-active-rheumatoid-arthritis-results-fro/.[Last accessed November 2019].

[3] Yoo DH, Jaworski J,Matyska-Piekarska E et al. A NovelFormulation of CT-P13 (Infliximab Biosimilar) for Subcutaneous Administration:One Year Results from Part One of a Phase I/III Randomised Controlled Trial inPatients with Rheumatoid Arthritis. Poster (FRI0128) Presented at EULAR 2019.

[4] Westhovens R, Wiland P,Zawadzki M et al. A Novel Formulationof CT-P13 (Infliximab Biosimilar) for Subcutaneous Administration: 30-weekResults from Part Two of a Phase I/III Randomised Controlled Trial in Patientswith Rheumatoid Arthritis. Poster (SAT0170) Presented at EULAR 2019.

[5] European Medicines AgencySummary of Product Characteristics (SmPC). CT-P13. Available athttp://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002576/WC500150871.pdf[Last accessed November 2019].