News | February 18, 2021

Fresenius Kabi Canada launches IDACIO® (adalimumab injection), A Biosimilar To HUMIRA® (adalimumab) For The Treatment Of Multiple Chronic Inflammatory Diseases

Biosimilars provide patients with access to affordable and relevant medicines.

Toronto, ON / CNW / - Fresenius Kabi Canada, a healthcare company specializing in drugs and infusion, transfusion and clinical nutrition technologies, today announced the launch of IDACIO ® , an adalimumab biosimilar, in Canada. The medicine is available immediately for all indications of the reference medicine in the fields of rheumatology, gastroenterology and dermatology. IDACIO received marketing authorization from Health Canada on October 30, 2020 and is the first biosimilar product launched in North America by Fresenius Kabi.

“Our core philosophy is 'Take Care of Life', and this authorization is the most recent example of how Fresenius Kabi provides relevant and affordable medicines to Canadian patients,” said Matthew Rotenberg, CEO, Fresenius Kabi Canada. "As partners in the health care system in Canada , we are known for our high quality standards and our manufacturing capabilities, and now, for biosimilars, we have invested in comprehensive programs that make use of our product simple for patients and will help physicians provide optimal care. "

KabiCare, Fresenius Kabi Canada's patient support program, provides patients with information, tools and support to help them during their treatment. KabiCare is a tailored program for patients and health care providers, offering reimbursement pathway services, financial assistance as well as personalized services that complement individual clinical processes.

The authorization of IDACIO® by Health Canada is based on evidence presented to Health Canada, including analytical, preclinical and clinical data on volunteers and healthy patients.i Indications were granted based on similarity between the biosimilar and the reference biologic drug, and IDACIO demonstrated that the pharmacokinetics, efficacy, safety and immunogenicity were similar to those of the reference product in the clinical development program.ii, iii, iv

“Although biologic therapies represent a small percentage of total prescription drugs in Canada , they contribute to a high cost relative to total prescriptions,” says Dr. Louis Bessette , MD, MSc, FRCPC. “In my opinion, biosimilars are a smart and pragmatic way to quickly ease the financial burden of healthcare costs. "

About IDACIO
IDACIO was developed by Fresenius Kabi. Health Canada has authorized IDACIO for the treatment of rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis, adult and adolescent hidradenitis, Crohn's disease adult and pediatric, ulcerative colitis, adult non-infectious uveitis and pediatric chronic non-infectious anterior uveitis.i

About Fresenius Kabi Canada
With more than 100 years of global experience, including over 30 years in Canada , Fresenius Kabi Canada is a long-standing partner in Canadian healthcare. The company is committed to maintaining the same high quality standards as original biologics in the development and production of biosimilar drugs, while meeting the unique needs of patients, healthcare professionals and the healthcare system. Canadian.

Fresenius Kabi has grown into a major supplier of generic intravenous drugs in Canada . Its product portfolio also includes pharmacies consisting of IV pharmaceuticals, infusion therapy and parenteral nutrition products as well as medical devices and devices and related consumables.

Fresenius Kabi believes that health care should never be "in formula one." This is why the company adopts a thoughtful approach to meet the unique needs of patients, practitioners and the health system Canada as a whole. As a system partner, Fresenius Kabi works closely with healthcare professionals, payers and patients to develop value-added services that improve patient care.

For more information, please visit https://www.fresenius-kabi.com/en-ca/ , and for more information on biosimilars, please visit www.fresenius-kabi.com/ en-ca / products / biosimilars

About Fresenius Kabi
Fresenius Kabi is an international company specializing in infusion, transfusion and clinical nutrition both in drugs and related technologies. Our products and services are intended to support patients with serious or chronic illnesses. Fresenius Kabi's product portfolio includes a full line of generic IV drugs, clinical nutrition and infusion products, as well as the medical devices required to deliver these products. In the field of biosimilars, Fresenius Kabi develops products focused on oncology and autoimmune diseases. In 2019, Fresenius Kabi launched his first biosimilar product. In the field of transfusion medicine and cell therapy,

Backed by our business philosophy of "taking care of life", we are committed to improving the quality of life for patients through the essential drugs and life-saving technologies that we make available to people. that help patients across the country.

For more information, visit https://www.fresenius-kabi.com/fr-ca/ .

Forward-Looking Statements
This press release contains forward-looking statements that are subject to various risks and uncertainties. Future results could differ materially from those described in these forward-looking statements due to certain factors, eg. eg, changes in business, economic and competitive conditions, regulatory reforms, results of clinical trials, fluctuations in currency exchange rates, uncertainties surrounding litigation or investigations, and the availability of funding. Fresenius Kabi assumes no responsibility for updating any forward-looking statements contained in this press release.

i

IDACIO ® Product Monograph. October 2020

ii

Hyland E, et al. Comparison of the pharmacokinetcis, safety and immunogenicity of MSB11022, a biosimilars of adalimumab, with Humira ® in healthy subjects. Br J Clin Pharmacol . 2016; 82 (4): 983-932

iii

Hercogova J et al. A randomized, double-blind trial comparing the efficacy, safety and immunogenicity of MSB11022, a proposed biosimilar of adalimumab, versus adalimumab originator in patients with moderate-to-severe plaque psoriasis. Am Acad Dermatol . 2018; 79 (3): AB21

iv

Hercogova J et al. AURIEL-PsO: Double-blind, phase III, randomized equivalence trial aimed at demonstrating the clinical similarity of the biosimilar MSB11022 to the reference adalimumab in patients with moderate to severe chronic plaque-type psoriasis. Br J Dermatol. 2020; 182: 316-326

Source: Fresenius Kabi

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