Kashiv BioSciences, LLC Obtains Marketing Authorization for Pegfilgrastim Injection from Health Canada

By: Kashiv BioSciences, LLC via Business Wire

February 25, 2025 at 08:45 AM EST

Kashiv BioSciences, LLC (“Kashiv” or the “Company”) today announced that Health Canada has granted marketing authorization for its Pegfilgrastim Injection, enabling its commercial launch in this market. This marks an important step in Kashiv’s strategy to expand access to high-quality biosimilars in global markets.

Pexegra^TMis a long-acting G-CSF biosimilar indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive antineoplastic drugs. The marketing authorization follows a rigorous regulatory review by Health Canada, ensuring that Kashiv’s Pegfilgrastim Injection meets the stringent quality, safety, and efficacy standards comparable to the reference biologic.

JAMP Pharma Group, Kashiv’s licensing partner in Canada, will spearhead the distribution and commercialization efforts. "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," said Louis Pilon, CEO of JAMP Pharma Group.

"The marketing authorization of our Pegfilgrastim Injection by Health Canada highlights Kashiv BioSciences’ expertise in the development of complex biologics and biosimilars," said Dr. Chandramauli Rawal, Chief Operating Officer of Kashiv BioSciences. "We are excited to partner with JAMP Pharma Group to expand access to high-quality biosimilars to patients in Canada.”

This regulatory recognition underscores Kashiv BioSciences’ commitment to meeting international standards in drug development. As part of its global strategy, Kashiv will continue to expand its partnerships and pursue marketing authorizations to bring innovative therapies to patients in need.

About Kashiv:

Kashiv BioSciences, LLC is a vertically integrated biopharmaceutical company with numerous commercial and advanced clinical-stage assets. Kashiv BioSciences, LLC in the United States, and its subsidiaries in India (together “Kashiv BioSciences”) operate together with robust infrastructure and highly skilled teams that provide global R&D, clinical, manufacturing, regulatory, and IP capabilities. We believe our people, partners, and shared purpose fuel our work to advance patient care and access to important medicines.

About JAMP Pharma Group

The JAMP Pharma Group is a Canadian organization headquartered in Boucherville, in the Greater Montreal area. Having experienced exceptional growth over the past ten years, the JAMP Pharma Group is present in all segments of the pharmaceutical market, with a portfolio of more than 350 molecules.