CelltrionHealthcare

• Yuflyma® is now available in Canada and offers a new treatment option for Canadian physicians and their patients
• Yuflyma® is an adalimumab biosimilar of Humira® with a high-concentration, low-volume and citrate-free formulation
• Celltrion Healthcare Canada Limited remains committed to providing a patient centric approach, to ensure access to innovative, high-quality biologics in Canada

TORONTO, April 11, 2022 /CNW Telbec/ - Celltrion Healthcare Canada Limited today announced the launch of Yuflyma®, a high-concentration (100 mg/mL), low-volume, citrate-free, and latex-free biosimilar to Humira® (adalimumab). The company received marketing authorization from Health Canada on December 24, 2021.

Yuflyma® is approved in ten 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

"We continue to deliver important milestones to increase accessibility and affordability to medicines for patients in Canada," said Glen Choma, Commercial Director at Celltrion Healthcare Canada. "We received a positive letter of intent from the pan-Canadian Pharmaceutical Alliance, with coverage by provincial formularies soon to come. In addition, we anticipate that Yuflyma® will be listed by the main private insurers from coast to coast. We are proud to expand our biosimilar portfolio in Canada, with Remsima™ SC in 2021, and now with Yuflyma®, bringing innovative therapies to help patients on their treatment journey."

With the launch of Yuflyma®, 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.

"In the United States and in Europe, practitioners have had the chance to provide patients with high-concentration versions of biosimilars of adalimumab. The availability of Yuflyma® in Canada is a welcomed addition for us and our patients for the management of their inflammatory conditions. With the specific features of Yuflyma®, such as lower volume of injection and a high-concentration formulation without citrate, it may provide additional clinical benefits for patients," said Dr. John K. Marshall, Professor of Medicine and Director of the Division of Gastroenterology at McMaster University, Hamilton, Ontario.

Yuflyma® is available in 2 device types: Auto-injector and Pre-filled Syringe with Safety Guard.

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Notes to Editors:

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/en-ca/home/main

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

For further information: Media Relations Contact: info_CA@celltrionhc.com; Mili.Kulugammana@celltrionhc.com