Sandoz Canada Receives Authorization From Health Canada To Launch New Biosimilar Hyrimoz® (adalimumab)

• Hyrimoz® approved for use in all same indications as reference medicine* including rheumatology, gastroenterology and dermatology.
• Third Sandoz biosimilar approved in Canada in past 11 months expanding its biosimilars portfolio to six and highlighting Sandoz commitment to broadening access to biosimilars.

Boucherville, QC (GLOBE NEWSWIRE) - Sandoz Canada Inc. announced today that Health Canada has authorized Hyrimoz® (adalimumab injection, reference biologic drug: Humira®) on November 4, 2020 for marketing in Canada. Hyrimoz® has been approved for the treatment of the same nine (9) life-threatening or serious debilitating conditions in adults and children as the reference medicine*, including the treatment of rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis, hidradenitis suppurativa, psoriasis and adult uveitis.

Hyrimoz® (adalimumab injection) is a fully human tumor necrosis factor (TNF) blocker. Adalimumab targets and blocks TNF, which helps reduce inflammation. The notice of compliance has been issued for three subcutaneous injection dosage forms: 40 mg/0.8 mL and 20 mg/0.4mL in prefilled syringe, 40 mg/0.8 mL in autoinjector.

“This approval is excellent news as over 42,000 Canadian patients are currently taking an adalimumab biologic¹. Our team is working hard to launch Hyrimoz® by February 15th 2021 to increase access to this high-quality, affordable biologic treatment for Canadian healthcare professionals and their patients. We are currently working on the reimbursement of Hyrimoz® to enable rapid access for patients.” said Karine Matteau, Vice President, Bio-Generic Hospital/Physician channel and Head Biosimilars at Sandoz Canada. “Sandoz is dedicated to growing our biosimilars portfolio in Canada and Hyrimoz® is an important driver for this in the immunology area, as it complements the recent biosimilar launches we had this year in immunology and oncology.”

“Sandoz is a global leader and a pioneer in biosimilars research, development, manufacturing and commercialization enabled by the Novartis group’s fully integrated end-to end model. We pride ourselves as being one company delivering both innovation and sustainability to the healthcare system in Canada. Hyrimoz® was successfully launched in Europe in 2018 and we are very proud that we have obtained approval to market it in Canada as it will allow us to broaden the use of biosimilars in the country, which will in turn reduce growing costs to the healthcare system and generate savings that can be reinvested in healthcare resources,” added Michel Robidoux, President and General Manager of Sandoz Canada.

A patient support program will be available to patients treated by Hyimoz®, providing guidance with reimbursement navigation, financial assistance, administrative support, as well as education for patients.

Sandoz Canada’s biosimilars portfolio includes biologic medicines covering the therapeutic areas of oncology, immunology and endocrinology.

About Biosimilars
A biosimilar biologic medicine, or biosimilar, is a biologic medicine that has demonstrated it is highly similar and has no clinically meaningful differences in efficacy and safety compared to an original-brand (“reference”) biologic² already authorized for sale. Biosimilars may become commercially available following the expiry of patents and data protection periods of the reference biologic medicine.

Since 2009, Health Canada has approved 32 biosimilars of original-brand biologics present on the Canadian market³.

Biosimilars have the potential to improve access to effective treatments while reducing the current economic burden on the Canadian healthcare system, patients, physicians and taxpayers as a whole. The Patented Medicines Pricing Review Board has estimated that private and public drug plans across Canada could save from $332 million CDN to $1.81 billion CDN in the third year following biosimilar entry across a portfolio of product⁴. The broader use of biosimilar medicines, including the implementation of biosimilar switching policies, can also help public and private drug plans improve their sustainability by adding new medicine listings and expanding existing medication coverage for patients. To that effect, the Ontario Drug Policy Research Network (ODPRN) recently released study report⁵ demonstrates that mandatory non-medical switching policies introduced in all provinces in 2019 (etanercept and infliximab only) could generate $239.6 million in national savings.

For further information on biosimilars in Canada, visit BiosimilarsGeneration.ca, which aims to support and educate patients, healthcare professionals and Canadians by providing policy updates from public drug plans, as well as evidence-based information and resources from Canadian, international research and clinical communities, and patient organizations representing Canadians living with chronic diseases who take biologic medicines.

® Trademark owned by the registered owner.

Disclaimer
The foregoing release contains forward-looking statements that can be identified by terminology such as “potential,” “can,” “soon,” “planned” or similar expressions, or by express or implied statements regarding potential marketing or new labelling approvals for Hyrimoz® or other potential products in the Sandoz pipeline of biosimilars, or regarding potential future revenues from the sale of Hyrimoz® or other marketed products from the Sandoz biosimilars portfolio or potential future revenues from the Sandoz portfolio of biosimilars in development. You should not place undue reliance on these statements. These forward-looking statements reflect management’s current beliefs and expectations regarding future events and involve known and unknown risks and significant uncertainties. Should one or more of these risks or uncertainties materialize, or should any of the underlying assumptions prove incorrect, actual results could differ materially from those set forth in the forward-looking statements. There can be no guarantee that Hyrimoz® or any other marketed product from the Sandoz portfolio of biosimilars will be submitted or approved for sale in other markets, or at any particular time. There can also be no guarantee that potential products from the Sandoz portfolio of biosimilars under development will be submitted or approved for sale in other markets, or at any particular time. There can also be no guarantee that, if approved, potential products in the Sandoz portfolio of biosimilars in development will be approved for all indications listed on the label of the reference product. There can also be no guarantee that Hyrimoz®, other marketed products in the Sandoz portfolio of biosimilars or other potential products in the Sandoz portfolio of biosimilars in development will be commercially successful in the future. In particular, management’s expectations regarding Hyrimoz® and other biosimilar candidates and marketed products could be affected by, among other things, regulatory actions, delays or government regulation generally; uncertainties inherent in research and development, including the results of clinical studies and further analysis of existing clinical data; competition in general, including potential approval of new versions of Hyrimoz®; the global trend toward rationalizing healthcare costs, including pricing pressures and reimbursement issues from healthcare payers, the general public and governments; the outcome of litigation, including intellectual property litigation and other legal actions to prevent or restrict the sale of Sandoz biosimilar products; physicians’ and patients’ particular prescription preferences; general economic and industry conditions; impacts of the COVID-19 pandemic; manufacturing, safety or quality issues; and other risks and factors referred to in Novartis AG’s Form 20-F on file with the US Securities and Exchange Commission. Sandoz is providing the information in this press release as of today and does not undertake any obligation to update any forward-looking statements described herein as a result of new information, future events or otherwise, except as required by the law.

About Sandoz
Sandoz International GmbH is a world leader in generics and biosimilars and a division of the Swiss multinational Novartis AG. A true leader in its field, Sandoz Canada markets and distributes a wide range of generics, biosimilars and specialty products.
www.sandoz.ca

Follow us on LinkedIn: https://www.linkedin.com/company/sandoz-canada/

References

1. Internal estimation based on IMS IQVIA analysis manager, September 2019
2. Health Canada Biosimilars Fact Sheet: Biosimilars Explained. https://www.canada.ca/en/health-canada/services/drugs-health-products/biologics-radiopharmaceuticals-genetic-therapies/applications-submissions/guidance-documents/fact-sheet-biosimilars.html
3. https://health-products.canada.ca/noc-ac/index-eng.jsp – accessed on November 10, 2020
4. Potential savings associated with biosimilars in Canada: Government of Canada. http://www.pmprb-cepmb.gc.ca/view.asp?ccid=1304
5. ODPRN － Crosby, M., Tadrous, M., & Gomes, T. (2020). Potential Cost Implications of Mandatory Non‐Medical Switching Policies for Biologics for Rheumatic Conditions and Inflammatory Bowel Disease in Canada. Clinical Pharmacology & Therapeutics. https://odprn.ca/wp-content/uploads/2020/10/Research-Minute-Cost-Implications-of-Non-Medical-Switching.pdf

^*Humira® (adalimumab) is a registered trademark of AbbVie Biotechnology, Inc.

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