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    Celltrion Healthcare announces the availability of..
    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. - ENDS - 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. 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 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 ___________________________________ 1 YUFLYMA® 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 February 24, 2022. 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
    2022-05-04
  • 4
    Celltrion Healthcare announces Canadian approval o..
    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 _____________________________________ 1 YUFLYMATM 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. Media Relations Contact: info_CA@celltrionhc.com; Hanbit.Kim@celltrionhc.com
    2022-02-03
  • 3
    New Drug Submission for its monoclonal antibody tr..
    Celltrion Healthcare announces acceptance and priority review by Health Canada of New Drug Submission for its monoclonal antibody treatment for COVID-19, regdanvimab (CT-P59) Celltrion Healthcare Canada remains committed to working closely with Health Canada to make its monoclonal antibody treatment for COVID-19 available in Canada TORONTO, Aug. 2, 2021 /CNW/ - Celltrion Healthcare Canada Limited announced today that the New Drug Submission (NDS) file for regdanvimab (CT-P59), a monoclonal antibody treatment for COVID-19, submitted to Health Canada as rolling submission on May 28, 2021 has completed the screening phase. Regdanvimab (CT-P59) has been screened and found acceptable for review as a New Drug Submission with flexibilities for designated COVID-19 drugs (NDS-CV). The rolling submission process was recommended and accepted under the Minister of Health's Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 (the ISAD IO) and transitioned to a New Drug Submission for COVID-19, which permits companies to submit safety and efficacy data and information as they become available.1 Often referred to as a rolling review, this allows Health Canada to start its review right away, as information continues to come in, to accelerate the overall review process. The Food and Drug Regulations have been amended to allow for modified requirements that facilitate the regulatory process for new COVID-19 drugs to receive a notice of compliance (NOC) through a new drug submission (NDS). The amendments maintain some of the mechanisms introduced through the ISAD IO, thus continuing to provide Canadians with quick access to safe and effective COVID-19 drugs.2 "We are pleased the New Drug Submission has been screened and accepted for review by Health Canada and anticipate this accelerated review process will enable people in Canada to have access to safe and effective treatment against COVID-19 as early as possible," said Jovan Antunovic, Commercial Director at Celltrion Healthcare Canada. "The initiation of a rolling submission for regdanvimab (CT-P59) in Canada is a significant milestone and we remain committed to closely working with the Canadian regulatory authorities." Celltrion's global Phase III data showed regdanvimab (CT-P59) significantly reduced the risk of COVID-19 related hospitalization, oxygen therapy or death by 72% for patients at high- risk of progressing to severe COVID-19 and 70% for all patients compared to placebo. In addition, patients who were treated with regdanvimab (CT-P59) reported a significantly shortened time to clinical recovery by at least 4.7 days for patients at high- risk of progressing to severe COVID-19 and by 4.9 days compared to placebo for all patients. The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has made its recommendation for regdanvimab (CT-P59) that CT-P59 can be considered a treatment option for patients at high risk of progressing to severe COVID-19, based on a reasonable likelihood that the medicine may provide clinical benefit, and a low likelihood of harm.3 Notes to Editors: About regdanvimab (CT-P59) CT-P59 was identified as a potential treatment for COVID-19 through screening of antibody candidates and selecting those that showed the highest potency in neutralizing the SARS-CoV-2 virus. Pre-clinical studies showed that CT-P59 strongly binds to the receptor binding domain (RBD) of SARS-CoV-2 and significantly neutralizes the wild type virus. In vitro and In vivo studies demonstrated potency of CT-P59 against multiple variants of concern including the Alpha (B.1.1.7, first identified in the UK), Beta (B.1.351, first identified in South Africa), Gamma (P.1, first identified in Brazil) and Delta (B.1.617.2, first identified in India) variants. Results from the global Phase I through III clinical trials of CT-P59 demonstrated a promising safety, tolerability, antiviral effect and efficacy profile in patients with mild- to- moderate symptoms of COVID-19. Celltrion also has recently commenced the development of a neutralizing antibody cocktail with CT-P59 which is expected to neutralize a wider range of new emerging variants of SARS-CoV-2. 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 Follow us on LinkedIn: https://www.linkedin.com/company/celltrion-healthcare-canada-ltd/ References 1 Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19. Available at: https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/drugs-vaccines-treatments/interim-order-import-sale-advertising-drugs.html 2 Guidance on amendments to the Food and Drug Regulations for drugs for use in relation to COVID-19: Overview. Available at: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/food-drug-regulations-amendments-covid-19.html 3 EMA issues advice on use of regdanvimab for treating COVID-19 | European Medicines Agency (europa.eu). Last accessed July 2021 SOURCE Celltrion Healthcare For further information: Media Relations Contact: info_CA@celltrionhc.com, SokHyun.Yun@celltrionhc.com, Toll-free: 1-855-904-1747
    2021-08-05

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