CelltrionHealthcare

• Yuflyma^®, an adalimumab biosimilar of Humira^®, is now available in 40 mg and 80 mg doses
• Yuflyma^® is the only adalimumab biosimilar that supplies an 80 mg dose in an auto-injector
• Yuflyma^® is manufactured and distributed by Celltrion Healthcare
• Celltrion Healthcare Canada Limited remains committed to providing a patient centric approach, to ensure access to innovative, high-quality biologics in Canada

TORONTO, Aug. 30, 2023 /CNW/ - Celltrion Healthcare Canada Limited today announced that Yuflyma^® (adalimumab) is now available in an 80 mg auto-injector and pre-filled syringe. The 80 mg option offers convenience for patients with fewer injections,* compared to the 40 mg option,¹ and is the only adalimumab biosimilar that supplies an 80 mg dose in an auto-injector.^1-8

"Yuflyma^® 80 mg is an example of Celltrion Healthcare's innovation and growth, providing more convenience for patients in Canada," said Glen Choma, Commercial Director at Celltrion Healthcare Canada. "We are proud to give patients the choice of fewer injections, in their device of choice – an auto-injector or pre-filled syringe."

In addition to the availability of Yuflyma^® 80 mg, Celltrion Healthcare Canada is also proud to offer CELLTRION CONNECT™, a patient-focused support program tailored to support patients and healthcare providers. The program provides guidance with reimbursement navigation, financial assistance, injection and nurse support services as well as pharmacy support services for patients throughout their treatment. For more information on CELLTRION CONNECT™ call 1-855-966-1648.

"The availability of Yuflyma^® 80 mg gives our patients the choice of fewer injections compared to the 40 mg option in the management of their inflammatory conditions. The added convenience is a welcomed feature of Yuflyma^®, along with its lower volume of injection and a high-concentration formulation without citrate," said Dr. Peter L. Lakatos, MD PhD DsC FEBG AGAF, Professor at the Department of Medicine, McGill University, McGill University Health Centre, Montreal General Hospital, Montreal, QC.

Yuflyma^® is a high-concentration (100 mg/mL), low-volume, citrate-free, and latex-free biosimilar to Humira^®.

Yuflyma^® is manufactured by Celltrion Healthcare Co., Ltd. and distributed by Celltrion Healthcare Canada Limited. Celltrion Healthcare represents a strong, vertically integrated worldwide supply chain. Founded in 2002, the company has over 20 years of experience developing biosimilars. Its state-of-the-art manufacturing facilities operate in full compliance with Health Canada and cGMP regulations.

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.

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 Health Canada regulations, 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

*For Crohn's disease, ulcerative colitis, hidradenitis suppurativa, plaque psoriasis and uveitis indications. Refer to the Product Monograph for complete dosing and administration information.

_____________________

¹YUFLYMA^® Product Monograph. Celltrion Healthcare Co., Ltd., February 3, 2023. Product information from Health Canada available at: https://pdf.hres.ca/dpd_pm/00069429.PDF. Accessed on July 17, 2023.

²Simlandi Product Monograph. Jamp Pharma Corporation. December 9, 2022. Available at: https://health-products.canada.ca/dpd-bdpp/.

³Hadlima/Hadlima PushTouch Product Monograph. Organon Canada Inc. December 14, 2022. Available at: https://health-products.canada.ca/dpd-bdpp/.

⁴Hyrimoz Product Monograph. Sandoz Canada Inc. October 11, 2022. Available at: https://health-products.canada.ca/dpd-bdpp/.

⁵Idacio Product Monograph. Fresenius Kabi Canada Ltd. October 30, 2020. Available at: https://www.fresenius-kabi.com/en-ca/documents/Idacio-Product-Monograph-En-022521.pdf.

⁶Abrilada Product Monograph. Pfizer Canada ULC. November 14, 2022. Available at: https://health-products.canada.ca/dpd-bdpp/.

⁷Amgevita Product Monograph. Amgen Canada Inc. September 9, 2022. Available at: https://www.amgen.ca/-/media/Themes/CorporateAffairs/amgen-ca/amgen-ca/documents/products/en/amgevita_pm.pdf.

⁸Hulio Product Monograph. BGP Pharma ULC. May 15, 2023. Available at: https://health-products.canada.ca/dpd-bdpp/.

YUFLYMA is a registered trademark of Celltrion Inc.

HUMIRA is a registered trademark of AbbVie Inc.