CelltrionHealthcare

Celltrion Healthcare announces Canadian approval of Vegzelma® (bevacizumab for injection) for the treatment of five types of cancer Vegzelma®, a bevacizumab biosimilar of Avastin®, is now approved by Health Canada Vegzelma® offers Canadian patients living with one of five types of cancer a new treatment option Celltrion Healthcare Canada Limited is committed to providing a patient centric approach, to ensure access to innovative, high quality, and affordable biologics in Canada TORONTO, Jan. 19, 2023 /CNW Telbec/ - Celltrion Healthcare Canada Limited today announced that Health Canada granted a notice of compliance (NOC) on January 3, 2023 for Vegzelma®, a biosimilar to Avastin® (bevacizumab for injection). The Health Canada authorization was based on a comprehensive data package of analytical, preclinical and clinical studies, demonstrating that Vegzelma® is highly similar to the reference product Avastin® in terms of efficacy, safety and pharmacokinetics.1 Vegzelma® is approved for the treatment of five types of cancer, including metastatic colorectal cancer (mCRC); locally advanced, metastatic or recurrent non-small cell lung cancer (NSCLC); platinum-sensitive recurrent epithelial ovarian, fallopian tube and primary peritoneal cancer; platinum-resistant recurrent epithelial ovarian, fallopian tube and primary peritoneal cancer; and malignant glioma (WHO Grade IV) – glioblastoma.1 "In cancer treatment, biologics play a key role and are principal components of many therapeutic regimens. However, the high cost of biologics is a burden on the healthcare system. Biosimilars enable access to more affordable medicines. The approval of Vegzelma® in Canada provides oncologists with another safe and effective option of a bevacizumab biosimilar for patients and for the healthcare community", said Dr. Winson Y. Cheung, Professor at the Departments of Medicine and Oncology, University of Calgary. "The approval of Vegzelma® reinforces our commitment to increase accessibility and affordability to medicines," said Glen Choma, Commercial Director at Celltrion Healthcare Canada. "This represents a significant step in expanding access to cancer care. And, as a leading force in the global biopharmaceutical industry, it demonstrates our willingness to strengthen our presence in Canada and contribute to a more sustainable healthcare system for the future. As we continue to grow our biosimilar portfolio in Canada, innovative therapies like Remsima™ SC, Yuflyma®, and now Vegzelma® are helping to make treatments more accessible to Canadians in need." Celltrion Healthcare Canada is also proud to offer CELLTRION CONNECT™, a patient-focused 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. Vegzelma® is Celltrion's first oncology biosimilar approved for use in Canada. Vegzelma® was authorized in the EU in August 2022 and the UK, US, and Japan in September 2022. Regulatory reviews are ongoing in additional countries. Notes to Editors: About Vegzelma® Vegzelma® is an anti-cancer monoclonal antibody treatment biosimilar to Avastin® (bevacizumab). Vegzelma® is a recombinant humanized monoclonal antibody which selectively binds to and neutralizes the biologic activity of human vascular endothelial growth factor (VEGF), the key driver of vasculogenesis and angiogenesis, and thereby inhibits the binding of VEGF to its receptors Flt-1 (VEGFR-1), and kinase insert domain receptor (KDR) (VEGFR-2), on the surface of endothelial cells. In Canada, Vegzelma® is indicated for the treatment of patients with metastatic colorectal cancer (mCRC); locally advanced, metastatic or recurrent non-small cell lung cancer (NSCLC); platinum-sensitive recurrent epithelial ovarian, fallopian tube and primary peritoneal cancer; platinum-resistant recurrent epithelial ovarian, fallopian tube and primary peritoneal cancer; and malignant glioma (WHO Grade IV) – glioblastoma.1 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 ___________________________________1VEGZELMA® Product Monograph. Celltrion Healthcare Co., Ltd., January 3, 2023. Product information from Health Canada available at: https://pdf.hres.ca/dpd_pm/00068966.PDF. Accessed on January 10, 2023. VEGZELMA is a registered trademark of Celltrion Inc. AVASTIN is a registered trademark of Genentech Inc. Media Relations Contact, info_CA@celltrionhc.com, Glen.choma@celltrionhc.com

2023-01-26

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

2021-06-07

2021-02-01