US-based biopharmaceutical company Kashiv BioSciences announced that Health Canada has granted marketing authorisation for its Pegfilgrastim Injection, branded as Pexegra.
This approval allows the commercial launch of Pegfilgrastim in Canada.
According to Kashiv BioSciences, the approval will support its plan to expand global access to high-quality biosimilars.
JAMP Pharma Group, Kashiv’s licensing partner in Canada, will lead the distribution and commercialisation activities.
JAMP Pharma Group CEO Louis Pilon said: “The addition of the Pegfilgrastim Injection to our BIOJAMP portfolio reinforces our commitment to providing Canadian patients with access to high-quality, cost-effective biosimilar medications.”
Pegfilgrastim Injection is a long-acting granulocyte-colony stimulating factor (G-CSF) biosimilar that helps reduce infection risk, including febrile neutropenia, in patients with non-myeloid malignancies undergoing myelosuppressive antineoplastic treatment.
The marketing authorisation follows a thorough Health Canada review, confirming that Kashiv BioSciences’ Pegfilgrastim Injection meets the high standards of quality, safety, and efficacy comparable to the reference biologic.
Kashiv BioSciences chief operating officer Chandramauli Rawal said: “The marketing authorisation of our Pegfilgrastim Injection by Health Canada highlights Kashiv BioSciences’ expertise in the development of complex biologics and biosimilars.
“We are excited to partner with JAMP Pharma Group to expand access to high-quality biosimilars to patients in Canada.”
Kashiv BioSciences is a vertically integrated biopharmaceutical company with a portfolio of commercial and clinical-stage assets.
Kashiv BioSciences is a vertically integrated biopharmaceutical company with a portfolio of commercial and clinical-stage assets.
Operating in the US and India, the company offers global expertise in research and development (R&D), clinical development, manufacturing, regulatory affairs, and intellectual property.
Last month, the biopharmaceutical firm announced that its abatacept biosimilar candidate, KSHB002, had achieved the primary endpoints in its Phase 1 trial. The trial showed pharmacokinetic equivalence to the US-licensed and European Union (EU)-authorised reference product, Orencia.
Kashiv BioSciences is developing KSHB002 in both subcutaneous and intravenous formulations.
