Sandoz Canada Receives Health Canada Approval To Launch Two Oncology Biosimilars: Ziextenzo® And Riximyo®

• Ziextenzo® is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-neoplastic drugs.
• Riximyo® is indicated to treat non-Hodgkin’s lymphoma and chronic lymphocytic leukemia and rheumatoid arthritis.
• These two approvals mark an important milestone for Sandoz Canada, bringing its biosimilars into oncology at a time when its biopharmaceutical portfolio already included products in immunology and endocrinology.

Boucherville, QC (GLOBE NEWSWIRE) - Sandoz Canada Inc., a division of Novartis AG, announced today that Health Canada has approved Ziextenzo® (pegfilgrastim, reference biologic drug: Neulasta®) and Riximyo® (rituximab, reference biologic drug: Rituxan®) for marketing in Canada.

Sandoz Canada received a Notice of Compliance from Health Canada on April 21, 2020, for the use of Ziextenzo® to reduce the incidence of febrile neutropenia, one of the most serious side effects of chemotherapy. Riximyo® was approved on April 28, 2020, to treat non-Hodgkin’s lymphoma, chronic lymphocytic leukemia and rheumatoid arthritis.

Neutropenia is a decrease in the number of neutrophils, a type of white blood cell, which predisposes the body to infections and prevents it from fighting them^¹.

According to statistics published by the Canadian Cancer Society^², in 2019 an estimated 21,000 Canadians received a blood cancer diagnosis, which makes up approximately 10% of all cancer diagnoses and includes non-Hodgkin’s lymphoma (10,000) and leukemia (6,700). Survival rates for blood cancers have increased over the years, but they still caused the deaths of 7,200 Canadians in 2016, according to a report released by The Leukemia & Lymphoma Society of Canada^³.

“These two new approvals are great news for patients, their physicians and the Canadian healthcare system. The use of biosimilars allows more patients to benefit from the advantages of biologic therapies while helping to reduce growing costs to the healthcare system and generate savings that can be reinvested in healthcare resources,” says Michel Robidoux, President and CEO of Sandoz Canada. “The approvals of Ziextenzo® and Riximyo® expand our portfolio of biosimilars in oncology. They also reinforce our status as the leading biosimilar and generic pharmaceutical company in Canada, which relies on our strong experience in these areas, our commitment to reliable supply and the excellence of our patient service programs.”

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

A biosimilar biologic drug, or biosimilar, is a biologic drug that has been shown to be similar to a brand-name drug already authorized for sale (referred to as a reference biologic drug). Biosimilars may become commercially available following the expiry of patents and data protection periods of the reference biologic drug. They 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 whole⁴.

“Sandoz, a division of Novartis, is a world leader in the field of biosimilars. The company invests in research and development to improve patients' quality of life and liberate healthcare resources through increased access to affordable biosimilars. With the Novartis group fully integrated end-to end model, we proudly ensure the reliable development, manufacture and supply of our full biosimilars portfolio in compliance with the industry's highest quality standards”, says Karine Matteau, Vice President, Bio-Generic Hospital/Physician channel and Head Biosimilars at Sandoz Canada. “Sandoz markets eight biosimilar drugs worldwide and we look forward to count five of them in Canada within the next twelve months.”

About Ziextenzo® (pegfilgrastim)
Ziextenzo® is a long-acting form of recombinant human granulocyte colony-stimulating factor (r-metHuG-CSF), or filgrastim. Ziextenzo® is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive antineoplastic agents.

About Riximyo® (rituximab)
Riximyo® is approved for the treatment of non-Hodgkin’s lymphoma (NHL) and chronic lymphocytic leukemia (CLL), as well as the autoimmune disease rheumatoid arthritis (RA). Riximyo® belongs to a family of medicines called monoclonal antibodies. Antibodies are proteins that are produced to bind to another protein, called an antigen. Riximyo® binds to an antigen located on the surface of a type of white blood cell, the B lymphocyte. When Riximyo binds to the surface of this cell, it causes the cell to die.

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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 Ziextenzo® and Riximyo® or other potential products in the Sandoz pipeline of biosimilars, or regarding potential future revenues from the sale of Ziextenzo® and Riximyo® 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 Ziextenzo® and Riximyo® 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 Ziextenzo® and Riximyo®, 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 Ziextenzo® and Riximyo® 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 Ziextenzo® and Riximyo®; 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; 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 Canada is a division of Sandoz International GmbH, 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. Canadian Cancer Society – https://www.cancer.ca/en/cancer-information/diagnosis-and-treatment/managing-side-effects/low-white-blood-cell-count/?region=on
2. Canadian Cancer Society – https://www.cancer.ca/en/about-us/for-media/media-releases/national/2019/canadian-cancer-statistics/?region=nl
3. The Leukemia & Lymphoma Society of Canada – https://www.llscanada.org/sites/default/files/National/CANADA/Pdf/InfoBooklets/Blood_Cancer_in_Canada_Facts_%26_Stats_2016.pdf
4. Potential savings associated with biosimilars in Canada: Government of Canada: http://www.pmprb-cepmb.gc.ca/view.asp?ccid=1304

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