AMGEVITA®, a Biosimilar to HUMIRA®* (adalimumab), is Now Available in Canada for the Treatment of Multiple Chronic Inflammatory Diseases

MISSISSAUGA, ON, May 4, 2021 /CNW/ – Amgen Canada today announced that AMGEVITA® (adalimumab, reference biologic drug: Humira®), is now available in Canada for the treatment of 11 chronic inflammatory conditions.

Amgen (CNW Group/Amgen Canada)

Amgen (CNW Group/Amgen Canada)

Treatment with AMGEVITA® should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult and pediatric (13 to 17 years of age weighing ≥ 40 kg) Crohn’s disease, ulcerative colitis, adult and adolescent (12 to 17 years of age weighing ≥ 30 kg) hidradenitis suppurativa, psoriasis or adult and pediatric uveitis and who are familiar with the AMGEVITA® efficacy and safety profile.i

“We are pleased that AMGEVITA® is now available in Canada, offering patients and physicians a treatment option and flexibility of choice in therapies they may not otherwise have,” says Suna Avcil, executive medical director, Amgen Canada. “AMGEVITA is an important milestone for Amgen’s biosimilar portfolio, expanding the number of treatment options available for Canadians living with chronic inflammatory diseases.”

AMGEVITA® is available as a prefilled syringe and a prefilled pen (SureClick® autoinjector) with a broad range of pack sizes to support dosing according to the approved dosage recommendations in each indication. Additionally, AMGEVITA® is provided in a citrate-free formulation.

“In my practice, I recognize the positive impact that access to additional therapeutic options can have on my patients and their quality of life,” said Dr. Kim Papp, Dermatologist, President and Director of Research at Probity Medical Research Inc. “The availability of AMGEVITA® offers specialists another important tool with which we can care for our patients living with chronic inflammatory disease.”

Biosimilars like AMGEVITA® are highly similar to, though often less expensive than, the original biologic therapies. In this way biosimilars, help increase the therapeutic options available to physicians and their patients and can help reduce the burden on Canada’s healthcare system.

AMGEVITA® is also now reimbursed on the public drug plans in British Columbia, Alberta, Ontario, Quebec, New Brunswick and Newfoundland for all available indications of the reference product.

About AMGEVITA®

AMGEVITA is a biosimilar to Humira® (adalimumab), a fully human immunoglobulin G1 monoclonal antibody that binds and neutralizes human tumor necrosis factor alpha (TNFα), a cytokine which mediates the inflammatory response. The amino acid sequence of AMGEVITA® is identical to that of the reference product.

About the AMGEVITA® Clinical Dataii

AMGEVITA® was approved based on a robust data package supporting biosimilarity to the reference product, Humira® brand adalimumab, based on analytical, nonclinical, pharmacokinetic and clinical data, including results from two confirmatory clinical studies conducted in moderate-to-severe psoriasis (PsO) and moderate-to-severe rheumatoid arthritis (RA) patients.

The comparative clinical studies each met their primary endpoint showing no clinically meaningful differences from Humira® brand adalimumab. Safety and immunogenicity of AMGEVITA® were also comparable to Humira® brand adalimumab, and the data included a double-blind randomized switch from Humira® brand adalimumab to AMGEVITA®. AMGEVITA® was also evaluated in a long-term study in moderate-to-severe RA patients, which found that efficacy was maintained with no new safety findings.

About Chronic Inflammatory Diseases

Following a physical injury, or in certain conditions, inflammation is a normal, healthy response; however, inflammatory disorders that result in the immune system attacking the body’s own cells or tissues may cause abnormal inflammation, which can result in chronic pain, redness, swelling, stiffness, and damage to normal tissues.iii In this case, the inflammation refers to a biological response to stimuli interpreted by the body to have a potentially harmful effect.iv

Millions of Canadians suffer from various chronic inflammatory diseases,v often considered “invisible” since it does not show telltale physical signs the way acute inflammation does.vi Chronic inflammatory diseases are a burden to humans because of life-long debilitating illness, increased mortality and high costs for therapy and care.vii

The only way to detect chronic inflammation is to have an evaluation by a doctor including a physical exam and blood tests.viii

About Amgen Canada
As a leader in innovation, Amgen Canada understands the value of science. With main operations located in Mississauga, Ont.’s vibrant biomedical cluster, and its research facility in Burnaby, B.C., Amgen Canada has been an important contributor to advancements in science and innovation in Canada since 1991. The company contributes to the development of new therapies and new uses for existing medicines in partnership with many of Canada’s leading health-care, academic, research, government and patient organizations. To learn more about Amgen Canada, visit www.amgen.ca.

Amgen Forward-Looking Statements
This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including its most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.

No forward-looking statement can be guaranteed and actual results may differ materially from those Amgen projects. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for Amgen to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and Amgen expects similar variability in the future. Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints Amgen has selected. Amgen develops product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as Amgen may have believed at the time of entering into such relationship. Also, Amgen or others could identify safety, side effects or manufacturing problems with its products, including its devices, after they are on the market.

Amgen’s results may be affected by its ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing its products and global economic conditions. In addition, sales of Amgen’s products are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment. Furthermore, Amgen’s research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. Amgen’s business may be impacted by government investigations, litigation and product liability claims. In addition, Amgen’s business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. While Amgen routinely obtains patents for its products and technology, the protection offered by its patents and patent applications may be challenged, invalidated or circumvented by its competitors, or Amgen may fail to prevail in present and future intellectual property litigation. Amgen performs a substantial amount of its commercial manufacturing activities at a few key manufacturing facilities, including in Puerto Rico, and also depends on third parties for a portion of its manufacturing activities, and limits on supply may constrain sales of certain of its current products and product candidate development. We rely on collaborations with third parties for the development of some of our product candidates and for the commercialization and sales of some of our commercial products. In addition, Amgen competes with other companies with respect to many of its marketed products as well as for the discovery and development of new products. Further, some raw materials, medical devices and component parts for Amgen’s products are supplied by sole third-party suppliers. Certain of Amgen’s distributors, customers and payers have substantial purchasing leverage in their dealings with Amgen. The discovery of significant problems with a product similar to one of Amgen’s products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on its business and results of operations. Amgen’s efforts to acquire other companies or products and to integrate the operations of companies Amgen has acquired may not be successful. A breakdown, cyberattack or information security breach could compromise the confidentiality, integrity and availability of Amgen’s systems and Amgen’s data. Amgen’s stock price may be volatile and may be affected by a number of events. Amgen’s business performance could affect or limit the ability of the Amgen Board of Directors to declare a dividend or its ability to pay a dividend or repurchase its common stock. Amgen may not be able to access the capital and credit markets on terms that are favorable to it, or at all.

*Humira (adalimumab) is a registered trademark of AbbVieBiotechnology Inc.

References

SOURCE Amgen Canada

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