CELLTRION-HEALTHCARE
Celltrion Healthcare today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the marketing authorisation of an adalimumab biosimilar candidate referencing Humira®1 , CT-P17 recommending approval for all available indications.
The CHMP positive opinion will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU). The EC’s decision regarding approval is expected in the first quarter of 2021, which would broaden treatment alternatives for patients suffering from rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), axial spondyloarthritis (AS), psoriatic arthritis (PsA), psoriasis (Ps), paediatric plaque psoriasis (pPs), hidradenitis suppurativa (HS), Crohn’s disease (CD), paediatric Crohn’s disease (pCD), ulcerative colitis (UC), uveitis (UV) and paediatric uveitis (pUV).
“If CT-P17 receives approval by the EC, Celltrion will be the first company to introduce an adalimumab biosimilar with high concentration and citrate-free formulation,” said HoUng Kim, Head of Medical and Marketing Division at Celltrion Healthcare. “This portfolio expansion is in line with our mission to improve access to biologics. We aim to provide a wide range of anti-TNF treatment alternatives, together with Remsima® dual formulation in IV formulation and SC formulation, for patients suffering from chronic inflammatory diseases.”
This positive opinion is based on the phase I/III studies to evaluate pharmacokinetics (PK), efficacy and safety between CT-P17 and reference adalimumab.2,3 The clinical data support the conclusion of biosimilarity of the proposed biosimilar and adalimumab to the reference product in terms of safety, efficacy, PK/PD and immunogenicity.
A randomised, double-blind phase III study in RA patients demonstrating similarity in terms of efficacy, pharmacokinetics (PK) and safety, including immunogenicity up to 24 weeks was presented at the ACR Convergence 2020.4 CT-P17 met the primary objective of demonstrating equivalent efficacy and its safety profile was comparable to that of reference adalimumab.
Further, a randomised, double-blind, single-dose study phase I study demonstrated PK and safety equivalence of CT-P17 in comparison to EU-approved adalimumab (EU - adalimumab) and US- licensed adalimumab (US - adalimumab) in healthy subjects up to 10 weeks. The overall safety profile was comparable, and the number of subjects who had positive ADA and neutralising ADA (NAb) results were also similar among the three treatment groups.2
Professor Edward Keystone, Senior Consultant Rheumatologist, Mount Sinai Hospital, Toronto, Canada said, “The CHMP positive opinion is very encouraging as CT-P17 has demonstrated promising study results in efficacy, PK and safety profile compared to reference adalimumab. Also having a high-concentration and citrate-free formulation would provide patients less pain during administration leading to improved quality of life.”
The EC takes binding decisions on the authorisation of medicines valid throughout the EU. It bases its decisions on scientific assessments by the CHMP, ensuring that medicines comply with high quality, safety and efficacy standards. If approved, the EC will grant a centralised marketing authorisation valid in all EU Member States as well as in the European Economic Area (EEA) countries Iceland, Liechtenstein and Norway.
- ENDS -
Notes to Editors:
About CT-P17 (biosimilar adalimumab)
CT-P17 is the first proposed high-concentration adalimumab biosimilar. If granted authorisation, CT-P17 will be indicated for the treatment of patients with rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), axial spondyloarthritis (AS), psoriatic arthritis (PsA), psoriasis (Ps), paediatric plaque psoriasis (pPs), 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-TNFα) monoclonal antibody. CT-P17 provides pain-reducing features as it comes with citrate-free formulation, meaning it causes less pain upon injection.
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 120 different countries. For more information please visit: https://www.celltrionhealthcare.com/en-us
Forward Looking Statement
Certain information set forth in this press release contains statements related to our future business and financial performance and future events or developments involving Celltrion/Celltrion Healthcare that may constitute forward-looking statements, under pertinent securities laws.
These statements may be identified by words such as “prepares”, “hopes to”, “upcoming”, ”plans to”, “aims to”, “to be launched”, “is preparing, “once gained”, “could”, “with the aim of”, “may”, “once identified”, “will”, “working towards”, “is due”, “become available”, “has potential to”, the negative of these words or such other variations thereon or comparable terminology.
In addition, our representatives may make oral forward-looking statements. Such statements are based on the current expectations and certain assumptions of Celltrion/Celltrion Healthcare's management, of which many are beyond its control.
Forward-looking statements are provided to allow potential investors the opportunity to understand management’s beliefs and opinions in respect of the future so that they may use such beliefs and opinions as one factor in evaluating an investment. These statements are not guarantees of future performance and undue reliance should not be placed on them.
Such forward-looking statements necessarily involve known and unknown risks and uncertainties, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or result expressed or implied by such forward-looking statements.
Although forward-looking statements contained in this presentation are based upon what management of Celltrion/Celltrion Healthcare believes are reasonable assumptions, there can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Celltrion/Celltrion Healthcare undertakes no obligation to update forward-looking statements if circumstances or management’s estimates or opinions should change except as required by applicable securities laws. The reader is cautioned not to place undue reliance on forward-looking statements.
References
1 Humira is a registered trademark of AbbVie Biotechnology Ltd
2 Yu KS, et al. (2020). Pharmacokinetics and Safety of CT-P17, a Proposed High Concentration (100 mg/mL) Adalimumab Biosimilar, in Comparison with EU-Approved Adalimumab and US-Licensed Adalimumab; Results of a Phase 1, Randomized, Double-blind, Three-arm, Single-dose Study in Healthy Subjects. Poster Presented at ACR Convergence 2020
3 National Library of Medicine (US). 2018 November - . A Study to Compare Efficacy and Safety of CT-P17 With Humira in Patients With Active Rheumatoid Arthritis. Identifier NCT03789292. Available from: https://clinicaltrials.gov/ct2/show/study/NCT03789292
4 J. Kay., et al. (2020). A Randomized, Double-Blind, Phase 3 Study to Compare the Efficacy and Safety of a Proposed High Concentration (100 mg/mL) Adalimumab Biosimilar (CT-P17) with Reference Adalimumab in Patients with Moderate-to-Severe Active Rheumatoid Arthritis. Poster Presented at ACR Convergence 2020
View source version on businesswire.com: https://www.businesswire.com/news/home/20201210006175/en/
Link:
About 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
MultiBank Group Confirms $MBG Token TGE Set for July 22, 202512.7.2025 11:14:00 CEST | Press release
MultiBank Group, the world’s largest financial derivatives institution has officially announced that the Token Generation Event (TGE) for its highly anticipated $MBG Token will take place on July 22, 2025. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250712404220/en/ MultiBank Group has officially announced that the Token Generation Event (TGE) for its highly anticipated $MBG Token will take place on July 22, 2025. This milestone will mark the full activation of the $MBG Token on the blockchain, enabling holders to view and manage their balances across supported platforms. Following the token minting, users will be able to trade $MBG via MultiBank.io, the Group’s regulated crypto exchange and Uniswap, the world’s leading decentralized platform. The $MBG Token has garnered global attention for its rare combination of real-world utility, institutional backing, and strong deflationary mechanics. It is underpinned by $29 billi
Elegen and Nutcracker Therapeutics to Pilot First Fully Cell-Free Manufacturing Process for RNA-based Personalized Cancer Therapeutics11.7.2025 14:00:00 CEST | Press release
Fully cell-free process aims to further democratize personalized cancer therapeutic manufacturing with shorter turnaround times and negligible bioburden and endotoxin risks. Elegen, a global leader in next-generation DNA manufacturing, and Nutcracker Therapeutics, a global leader in next-generation RNA design and manufacturing, today announced the launch of a pilot program to demonstrate the industry’s first fully synthetic, cell-free manufacturing platform for RNA-based personalized cancer therapeutics (PCTs). The pilot marks another step toward making PCTs more accessible, timely, and scalable. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250711152688/en/ As late-stage PCT clinical trials progress and therapy developers work to create the next generation of PCTs, the speed, reliability, scaling and cost of traditional production methods pose a major challenge. Specifically, the first step of DNA template production is hi
$MBG Token Pre-Sale Set for July 15 — Only 7 Million Tokens Available at $0.3511.7.2025 10:17:00 CEST | Press release
MultiBank Group, the world’s largest financial derivatives institution headquartered in Dubai, has confirmed that its highly anticipated $MBG Token pre-sale will go live on July 15, with demand expected to be intense. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250711737311/en/ With only 7 million $MBG tokens up for grabs at an exclusive entry price of $0.35, this is a rare opportunity to secure early access to what many are calling the year’s most powerful utility asset. With only 7 million tokens up for grabs at an exclusive entry price of $0.35, this is a rare opportunity to secure early access to what many are calling the year’s most powerful utility asset. Early participants can join simultaneously on MultiBank.io, the Group’s regulated crypto exchange, and Uniswap, the world’s leading decentralized platform. Supported by $29 billion in real assets and powered by over $35 billion in daily turnover, $MBG is engineered
Live Story Raises €2.7 Million to Revolutionize the Digital Experience11.7.2025 10:05:00 CEST | Press release
With a round led by Vertis, the next-generation CMS platform accelerates its focus onAI, performance, and European expansion. Target: surpass €10M in recurring revenueby 2027. Live Story, the tech company founded by Stefano Mocellini, has closed a €2.7 million seed round led by Vertis, one of Italy’s leading early-growth venture capital firms. The funding will support the company’s international expansion and technological development, with a clear goal: to exceed €10 million in annual recurringrevenue by 2027. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250711335560/en/ “We invested in Live Story because it addresses one of the major inefficiencies in digital commerce: the slow and rigid management of visual and narrative content,” says Alessandro Pontari, Partner at Vertis SGR. “The platform helps brands drastically reduce their time-to-market through a visual CMS that integrates seamlessly with any tech stack. In a wor
With a Score of 84 out of 100, Sagemcom Is Awarded the EcoVadis Platinum Medal: a Prestigious Recognition of its CSR Commitment11.7.2025 09:00:00 CEST | Press release
Sagemcom Group is proud to announce that it has been awarded, for the third time, the Platinum Medal by EcoVadis, the highest distinction granted by the leading global platform for assessing Corporate Social Responsibility (CSR) performance. This medal places Sagemcom in the top 1% of companies evaluated worldwide, across all industries. With a score of 84 out of 100, Sagemcom reaffirms its position as a committed leader in ecological transition, business ethics, sustainable supply chain management, and social responsibility. “The EcoVadis Platinum Medal is more than just an award — it is the recognition of our collective efforts to embed sustainable development principles at the heart of our corporate strategy and culture,” says Sylvaine Couleur, Executive Vice President, CSR & Communication. “Achieving this level demonstrates that our commitments are tangible, impactful, and internationally recognized. This distinction strengthens our determination to further advance and expand our C
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