Sandoz Canada gets approval to launch oncology biosimilars Ziextenzo, Riximyo

Boucherville: Sandoz Canada Inc., a division of Novartis AG, has announced 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.

According to statistics published by the Canadian Cancer Society, 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.

"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 whole.

"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."

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