Sandoz Canada Launches Ziextenzo, Riximyo

Sandoz Canada has launched its pegfilgrastim (Ziextenzo) and rituximab (Riximyo) biosimilars on the Canadian market. The marketing follows completion of an agreement with the Pan-Canadian Pharmaceutical Alliance (pCPA), which negotiates drug prices for all 13 Canadian provinces and territories.

In June, the company announced that it had received regulatory approval from Health Canada for both products.

“The addition of Ziextenzo and Riximyo in Canada will provide greater access to Canadian patients in the immunology and oncology areas,” Michel Robidoux, president and general manager of Sandoz Canada, said in a statement.

Ziextenzo is a long-acting form of recombinant human granulocyte colony-stimulating factor used to decrease the risks of infection as a result of febrile neutropenia (FN) in patients with nonmyeloid malignancies receiving chemotherapy agents.

Riximyo is a monoclonal antibody that is used for the treatment of patients with non-Hodgkin lymphoma, chronic lymphocytic leukemia, and rheumatoid arthritis.

The launches “allow for a broader use of biosimilars that can help reduce growing costs to the health care system and generate savings that can be reinvested in healthcare resources,” Karine Matteau, vice president of the Bio-Generic Hospital/Physician channel and Head Biosimilars at Sandoz Canada, said in a statement.

Reimbursement Agreement

Sandoz Canada has already initiated marketing of Ziextenzo and Riximyo across Canada.

In Ontario, Riximyo will be reimbursed through Canada’s limited use and exceptional access programs, which are for drugs that have specialized uses or are not available in the country, respectively. In British Columbia, Riximyo will be paid for through BC Cancer, the British Columbia oncology coordination system.

Sandoz Canada is working to expand reimbursement for Riximyo in other provinces and with private payers, and is working to secure both public and private payer coverage for Ziextenzo, according to a company representative.

Although the pCPA conducts joint provincial, territorial and federal drug plan negotiations for brand name and generic drugs, final drug funding decisions are made under the authority of individual jurisdictional public drug plans. The list price is generally made public when a jurisdiction lists a drug product.

“In addition to our agreement with the [pCPA] for both biosimilars, we are currently working with individual provinces to include these medicines on formulary coverage. This is great news for patients and their health care professionals as we expand biologic treatment options for patients with life-threatening or serious debilitating conditions,” Matteau said.

More on Riximyo and Ziextenzo

Currently, Ziextenzo is available in the European Union and was launched in the United States in 2019. In May, a study by Sandoz supported the expanded use of Ziextenzo for patients at intermediate risk of developing FN.

Riximyo is available in the European Union, Switzerland, Japan, New Zealand, and Australia. However, Sandoz decided to not seek FDA approval after its biologics license application for Riximyo was denied in May 2018.

Sandoz’ Other Biosimilars

Sandoz Canada has 2 other biosimilars in addition to Riximyo and Ziextenzo, including a somatropin (Omnitrope) injection, referencing Serostim, and an etanercept (Erelzi) biosimilar, referencing Enbrel.

Omnitrope is used in patients with growth hormone deficiencies and is marketed in the European Union and the United States; however, it is regulated as a reference biologic in the United States because it received approval before a biosimilar regulatory pathway existed there.

Erelzi is used to treat patients with rheumatoid arthritis, juvenile idiopathic arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and axial spondyloarthritis. It was approved in the United States in 2016 but has yet to enter the market. Erelzi is also approved in the European Union and has been on the market since 2017.