Business Wire

Celltrion Healthcare Presents Positive One-Year Data for the First High-Concentration, Low-Volume and Citrate-Free Biosimilar Adalimumab, Yuflyma TM (CT-P17) in Patients With Rheumatoid Arthritis at EULAR 2021

Share

Celltrion Healthcare today presented positive results from the Phase III CT-P17 3.1 trial comparing the efficacy and safety of biosimilar adalimumab,Yuflyma™, with reference adalimumab in patients with active rheumatoid arthritis (RA) at the Annual European Congress of Rheumatology 2021 (EULAR Virtual Congress 2021). The trial met its primary and secondary endpoints, demonstrating that the efficacy, pharmacokinetics (PK), safety and immunogenicity of CT-P17, a high-concentration (100mg/mL), low-volume and citrate-free adalimumab biosimilar, is comparable to reference adalimumab in the treatment of patients with moderate-to-severe active RA up to one year. The abstract has been published in an official supplement of the Annals of Rheumatic Diseases (ARD).1

The randomised, double-blind, Phase III study has demonstrated therapeutic equivalence of CT-P17 to reference adalimumab in 648 patients with active moderate-to-severe RA, despite methotrexate treatment, who were randomised (1:1) to receive either 40mg of CT-P17 or reference adalimumab every two weeks up to week 24.2 Prior to dosing at week 26, 608 patients were randomised again to either maintaining their treatment or being switched from reference adalimumab to CT-P17. After the second randomisation, 303 patients continued with CT-P17, 153 patients continued with reference adalimumab and 151 patients were switched from reference adalimumab to CT-P17 up to week 48.

Results demonstrated comparable efficacy in terms of ACR20/50/70 response rates, both in patients receiving maintenance therapy and in patients switched from reference adalimumab to CT-P17 up to week 52. With respect to PK, mean Ctrough levels were maintained after week 24 in all three treatment groups with the observed mean Ctrough levels recorded within the reported therapeutic ranges of reference adalimumab trough levels (5-8 µg/ml) in RA patients. The safety profile among the three treatment groups was comparable, with the most common treatment-emergent adverse event (TEAE) being neutropenia and similar proportions seen across all treatment groups experiencing at least one TEAE: injection site reactions, hypersensitivity/allergic reactions and infections. Anti-drug antibody (ADA) and neutralising antibody (NAb) results were also similar among the three treatment groups; the proportions of patients who had ADA/NAbs were 28.4%/24.8% in CT-P17 maintenance, 27.0%/24.3% in reference adalimumab maintenance and 28.3%/26.3% in switched to CT-P17 groups.

Professor Jonathan Kay of the University of Massachusetts Medical School and Principal Investigator of the trial said, “CT-P17 is administered at 100 mg/mL, reflecting the high-concentration formulation of reference adalimumab, and is also citrate-free, which could lessen discomfort during injection. Demonstration of equivalent efficacy and comparable safety of CT-P17 to EU-sourced adalimumab in this study supports the ongoing clinical evaluation of CT-P17 as an adalimumab biosimilar.”

Celltrion are also pleased to announce that the European Commission (EC) has granted marketing authorisation for Remsima® SC (infliximab) to be used without IV infusion both for new and existing RA patients.3 The EC approval follows a positive Committee for Medicinal Products for Human Use (CHMP), of the European Medicines Agency (EMA), opinion issued for direct use of subcutaneous therapy without IV loading in adults with RA in March 2021.

“Celltrion now has biosimilars of both infliximab and adalimumab with value-added features, and thus CT-P17 could be used sequentially with Remsima® SC to bring clinical benefit for chronic diseases which require long- term treatment,” said Dr. HoUng Kim, Ph.D., Head of Medical and Marketing Division at Celltrion Healthcare. “Having both Remsima® SC and Yuflyma™ in our product pipeline furthers our efforts to deliver value-added medicines to both payers and patients.”

- ENDS -

Notes to Editors:

About CT-P17 (biosimilar adalimumab)

CT-P17 is the first proposed high-concentration, low-volume and citrate-free adalimumab biosimilar. CT-P17 is indicated for the treatment of patients with rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (pJIA), enthesitis-related arthritis (ERA), ankylosing spondylitis (AS), axial spondyloarthritis without radiographic evidence of AS (nr-axSpA), psoriatic arthritis (PsA), psoriasis (PsO), paediatric plaque psoriasis (pPsO), hidradenitis suppurativa (HS), Crohn’s disease (CD), paediatric Crohn’s disease (pCD), ulcerative colitis (UC), uveitis (UV) and paediatric uveitis (pUV). CT-P17 is a recombinant human monoclonal antibody that contains the active ingredient adalimumab. Adalimumab is a fully human anti–tumour necrosis factor α (anti-TNF-α) monoclonal antibody. CT-P17 provides pain-reducing features as it has a citrate-free formulation, meaning it causes less pain upon injection.

About Remsima® CT-P13 subcutaneous (SC) formulation4,5

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 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 Ann Rheum Dis, volume 80, supplement 1, year 2021, page 1123

2 Furst D, et al. Efficacy and Safety after Transition from Reference Adalimumab to CT-P17 (Adalimumab Biosimilar: 100mg/mL) in comparison with the Maintained Treatment (CT-P17 or Reference Adalimumab) in Patients with Moderate-to-Severe Active Rheumatoid Arthritis: 1-Year Result. Abstract 325. Presented at EULAR 2021.

3 European Medicines Agency Summary of Product Characteristics (SmPC) Available at https://www.ema.europa.eu/en/documents/product-information/remsima-epar-product-information_en.pdf [Last accessed May 2021].

4 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.

5 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.

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

Contact information

Holly Barber
hbarber@hanovercomms.com
+44 (0) 7759 301620

Donna Curran
dcurran@hanovercomms.com
+44 (0) 7984 550312

About Business Wire

Business Wire
Business Wire



Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

ČSOB Insurance Selects Earnix to Implement Personalized Consumer P roducts and Rates15.6.2021 11:00:00 CEST | Press release

Earnix, a global provider of advanced rating, pricing, and product personalization solutions for insurers and banks, has been selected by one of the largest banking and insurance institutions in the Czech Republic, ČSOB Group, to integrate Earnix’s analytical personalization system into its personal lines insurance offering. Driven by cutting-edge analytics, artificial intelligence (AI) and machine learning (ML), Earnix’s “Personalize-It” solution determines and delivers the optimum product bundle(s) for insurance customers, thereby making the purchasing experience highly personalized and increasing consumer satisfaction while improving conversion and retention rates. “With our solution, ČSOB Insurance can take personalization to a higher level while meeting business objectives and maintaining a competitive advantage in the market,” said Udi Ziv, CEO at Earnix. “At a time when consumers are provided with dozens of insurance options, we empower insurers to position themselves as the bes

Samsung Brings Flagship Features to Broader Smartphone Market with LPDDR5 Multichip Package15.6.2021 10:00:00 CEST | Press release

Samsung Electronics Co., Ltd., the world leader in advanced memory technology, today announced that it has begun mass producing its latest smartphone memory solution, the LPDDR5 UFS-based multichip package (uMCP). Samsung’s uMCP integrates the fastest LPDDR5 DRAM with the latest UFS 3.1 NAND flash, delivering flagship-level performance to a much broader range of smartphone users. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210615005507/en/ Samsung's uMCP with industry’s highest performance, capacity and efficiency for 5G applications (Photo: Business Wire) “Samsung’s new LPDDR5 uMCP is built upon our rich legacy of memory advancements and packaging know-how, enabling consumers to enjoy uninterrupted streaming, gaming and mixed reality experiences even in lower-tier devices,” said Young-soo Sohn, vice president of the Memory Product Planning Team at Samsung Electronics. “As 5G-compatible devices become more mainstream, we

Startups from 21 Countries Showcase Deep Tech Innovations at #InnoVEXVirtual15.6.2021 09:23:00 CEST | Press release

Startups are the key to technology development, and they are the driver for industry transformations and evolutions. In COMPUTEX 2021 Virtual, the event organizer, TAITRA, has dedicated a special hall for #InnoVEXVirtual. With 81 startups from 21 countries, TAITRA aims to empower these startups by bridging the network and business opportunities with them and the global technology ecosystem through the digital platform. Sparking creativity with global disruptors Since its first establishment in 2016, InnoVEX, the exhibit dedicated to startups at COMPUTEX, has successively hosted National Pavilions from France, Korea and the Netherland. The National Pavilions have become one of the exhibition highlights to the visitors, venture capitalists and media. This year, La French Tech Pavilion, organized by Business France, gathers 5 teams to showcase tech strength and diversity from France in the fields including Quantum Computing as a Service, Organic Photovoltaic, Wireless Charging, Processing

MACIF’s Successful Euro 1,75 bn Issuance Attracted Huge Appetite From European Investors15.6.2021 09:05:00 CEST | Press release

MACIF, Aéma Groupe’s affiliate, announces the successful issuance of a multi-tranche €1.75bn subordinated debt issuance comprising: - a €400mn Perpetual Non-Call 2029 Restricted Tier 1 fixed resettable rate notes bearing interest at an initial fixed rate of 3.50% until the first call date and expected to be rated Ba1 by Moody’s - a €850mn 2052 Non-Call 2032 Tier 2 fixed to floating rate notes bearing interest at an initial fixed rate of 2.125% until the first call date and expected to be rated Baa1 by Moody’s - a €500mn 2027 Tier 3 notes bearing interest at a 0.625% fixed rate coupon and expected to be rated Baa1 by Moody’s MACIF has met with over 85 institutional investors over phone calls which took place from 8th to 11th June 2021 in order to present the Group’s credit. With more than 400 investors participating into the multi-tranche transaction for a total book size over €12.1bn, this represents the first Euro triple-tranche subordinated from a European insurer. The three days of

Aragen Announce Multi-Year Partnership With FMC Corporation, Aims at Accelerating Agro-Chemical Pipeline15.6.2021 09:03:00 CEST | Press release

Aragen Life Sciences (formerly, GVK BIO), a leading Contract Research and Development Organization (CRDO), head quartered out of Hyderabad, India, announced a strategic partnership with FMC Corporation, a global leader in innovative agricultural science, that provides solutions towards crop protection, plant health, and professional pest and turf management. Through this collaboration, Aragen will support FMC’s global discovery and development needs, including discovery chemistry, discovery biology, and chemical process development. This partnership is focused on accelerating FMC Corporation’s agro-chemical pipeline. “It has been our privilege to have been able to assist FMC, one of the global leaders in crop science, accelerate its R&D, through this long term partnership. The expansion of this collaboration through all facets of discovery and development is a testimony to the trust and confidence that FMC has in Aragen - we look forward to driving several more success stories for our

KeyBank Goes Live With SmartStream’s Cloud Collateral Management Solution15.6.2021 09:00:00 CEST | Press release

SmartStream Technologies, the financial Transaction Lifecycle Management (TLM®) solutions provider, today announces KeyBank N.A. goes live with its TLM Collateral Management (formerly Algorithmics/IBM Collateral) OnDemand solution - offering coverage for cleared and non-cleared, over the-counter (OTC) derivatives, repo and securities lending margining. KeyBank needed to streamline its back-office workflow with a cloud offering that would enhance efficiencies within their collateral management operations - this included all data capture, validation, calculation and processing. In addition, the use of APIs links the application to various other reporting solutions and downstream systems. A powerful user interface provides clear and logical paths for the user, and a management dashboard will help with trend analysis and decision-making. Paula Janofsky, Swap Operations Director, KeyBank, states: “Moving to the cloud enabled us to further improve and automate our operational and credit risk

Polymateria Awarded as Technology Pioneer by World Economic Forum15.6.2021 09:00:00 CEST | Press release

Polymateria, the London-based British tech company that last year produced the world’s first fully recyclable and biodegradable plastic, was selected among hundreds of candidates as one of the World Economic Forum’s “Technology Pioneers”. Polymateria came through Imperial College London’s incubator system and counts a diverse portfolio of customers and partners from Indorama Ventures, to Hollywood Actress Robin Wright, purposeful auto racing Extreme E, Rolling Loud Festivals, DAZN Sports TV network and the Indian Government. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210615005173/en/ The World Economic Forum’s Technology Pioneers are early to growth-stage companies from around the world that are involved in the use of new technologies and innovation that are poised to have a significant impact on business and society. With their selection as Technology Pioneer, CEO Niall Dunne of Polymateria will be invited to participat

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom