Sandoz Gets Canada's Nod to Launch Ziextenzo, Riximyo

Canadian authorities have given Sandoz Canada approval to launch 2 oncology biosimilars: a pegfilgrastim (Ziextenzo) and a rituximab (Riximyo).

“These 2 new approvals are great news for patients, their physicians, and the Canadian health care system,” said Michel Robidoux, president and CEO of Sandoz Canada, in a statement. “The use of biosimilars allows more patients to benefit from the advantages of biologic therapies while helping to reduce growing costs to the health care system and generate savings that can be reinvested in health care resources.”

Ziextenzo

Ziextenzo is indicated for the prevention of febrile neutropenia (FN) in patients with nonmyeloid malignancies receiving myelosuppressive antineoplastic chemotherapy drugs.

In May, a study by Sandoz supported the expanded use of biosimilar pegfilgrastim for patients at intermediate risk of developing FN, and switching patients at high risk from reference pegfilgrastim could save millions in health care costs.

Ziextenzo launched in the United States in November 2019. The drug also is marketed in the European Union.

Riximyo

Riximyo is used to treat non-Hodgkin lymphoma, chronic lymphocytic leukemia, and rheumatoid arthritis.

Results from a study published in 2019 confirmed that Riximyo had no increased safety risks compared with reference rituximab.

Riximyo has been on the European market since 2017. In November 2018, Sandoz decided not to seek FDA approval after having its biologics license application for Riximyo denied in May 2018. Riximyo is also marketed in Switzerland, Japan, New Zealand, and Australia, according to Sandoz.

In 2019, an estimated 10,000 Canadians received a diagnosis of non-Hodgkin lymphoma and another 6700 for leukemia, according to the Canadian Cancer Society.

Other Sandoz Biosimilars

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

The approvals by Health Canada mark a foray into oncology for the company’s biosimilars division, Sandoz said. “These 2 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.”

Omnitrope is used in patients with growth hormone deficiencies and is available in the European Union and the United States; however, it is regulated as a reference biologic in the United States because it was approved prior to the existence of an established regulatory pathway for biosimilars.

Erelzi is used for the treatment of 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 not yet launched. Erelzi also is approved in the European Union, where it has been on the market since 2017.