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:

ClickThru