Celltrion Healthcare announces Canadian approval of Yuflyma™, a high-concentration, low-volume, citrate-free, and latex-free Humira® (adalimumab) biosimilar

• Yuflyma^™ is an adalimumab biosimilar with a high-concentration, low-volume and citrate-free formulation; approved for all eligible indications of the reference biological product, Humira^® (adalimumab)
• Yuflyma^™ brings a new offering to healthcare practitioners and their patients with inflammatory diseases in Canada
• Celltrion Healthcare Canada Limited remains committed to providing a patient centric approach, to ensure access to innovative, high-quality biologics in Canada

TORONTO, Jan. 31, 2022 /CNW Telbec/ - Celltrion Healthcare Canada Limited is very pleased to announce that Health Canada granted a notice of compliance (NOC) on December 24, 2021 for Yuflyma^™, a high-concentration (100mg/mL), low-volume, citrate-free, and latex-free biosimilar to Humira^® (adalimumab). Yuflyma™ is approved across all ten intended indications for the treatment of multiple chronic inflammatory diseases, including rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn's disease, adult ulcerative colitis, hidradenitis suppurativa, plaque psoriasis, adult uveitis, and pediatric uveitis.¹

The Health Canada approval was based on a comprehensive data package of analytical, preclinical and clinical studies, demonstrating that Yuflyma^™ is comparable to the reference product Humira^® (adalimumab), in terms of safety, efficacy, PK/PD and immunogenicity up to 24 weeks and one year following treatment.²

According to IQVIA, in Europe, a high-concentration formulation represents 60% of the entire adalimumab market, and over 90% of the original adalimumab market has already been replaced with a high-concentration version.³ In the United States, high-concentration adalimumab represents about 80% of the total market for this agent.

"We are very pleased to receive this approval from Health Canada. This represents a significant step in providing the medical community and patients here in Canada with a new therapeutic option. It is also an important milestone to increase accessibility and affordability to medicines," said Glen Choma, Commercial Director at Celltrion Healthcare Canada. "We now have biosimilars of both infliximab and adalimumab with value-added features that have the potential to help even more Canadians suffering from chronic inflammatory diseases which require long-term treatment. We are proud to build on our biosimilar portfolio with innovative features to further expand patient access to Canadians in need."

Notes to Editors:

About Yuflyma^™ (CT-P17, biosimilar adalimumab)

Yuflyma^™ is the world's first high-concentration, low-volume and citrate-free adalimumab biosimilar. Yuflyma^™ is indicated for the treatment of patients with rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn's disease, adult ulcerative colitis, hidradenitis suppurativa, plaque psoriasis, adult uveitis, and pediatric uveitis. Yuflyma^™ 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. Yuflyma^™ provides clinically important features, such as a citrate-free formulation, which may lead to 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 U.S. 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.ca/en-ca/home/main

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¹ YUFLYMA^TM Product Monograph. Celltrion Healthcare Co., Ltd., December 24, 2021. Product information from Health Canada available at: https://pdf.hres.ca/dpd_pm/00064135.PDF. Accessed on January 24, 2022.

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

³ IQVIA 2021. Data on File.

YUFLYMA is a trademark of Celltrion Inc.
HUMIRA is a registered trademark of AbbVie Inc.

SOURCE Celltrion Healthcare

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