Health Canada has granted approval to Nora Pharma for the commercialisation of its first biosimilar product, Niopeg (a pegylated form of filgrastim).

The Niopeg is comparable to the reference biologic drug Neulasta.

Nora Pharma, a division of Sunshine Biopharma, president Malek Chamoun said: “With this product, we demonstrate to the Canadian market our determination to be a leader in the pharmaceutical sector.

“This is an important milestone for our mission of bringing high-quality affordable medicines to patients across Canada.”

Niopeg is a long-acting form of recombinant human granulocyte colony-stimulating factor or filgrastim.

It is specifically indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies who are receiving myelosuppressive anti-neoplastic drugs.

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The biosimilar Niopeg will be available in Canada in a prefilled syringe containing 6mg/0.6ml.

Sunshine Biopharma CEO Dr Steve Slilaty said: “Niopeg is used to help prevent infection in people with non-myeloid cancers who are receiving chemotherapy. An example of a non-myeloid cancer is breast cancer.

“Biosimilars will have a significant impact on the sustainability of drug insurance plans, ensuring patient access to these high-quality treatments for years to come.”

Nora Pharma was acquired by Sunshine Biopharma in 2022.

Through Nora Pharma, Sunshine Biopharma has 52 generic prescription drugs on the market in Canada.

By the end of this year, Sunshine Biopharma plans to expand its product offering to a total of 60 generic prescription drugs.

It is also continuing its drug development programme, which includes K1.1 messenger RNA for liver cancer, and PLpro protease inhibitor for SARS coronavirus infections.