Kashiv BioSciences has successfully launched two biosimilar products in Canada through an exclusive partnership with JAMP Pharma Corporation, marking a significant expansion of affordable treatment options for cancer patients experiencing neutropenia.
Product Launch Details
The commercial launch includes Pexegra, a biosimilar referencing Neulasta (pegfilgrastim), and Filra, a biosimilar referencing Neupogen (filgrastim). Pexegra is available as a 6 mg/0.6 mL pre-filled syringe, while Filra comes in two formulations: 300 mcg/0.5 mL and 480 mcg/0.8 mL pre-filled syringes.
Both products are designed to treat neutropenia, a condition characterized by low levels of neutrophils—white blood cells that fight infection—commonly experienced by patients undergoing chemotherapy. The biosimilars are equipped with UltraSafe Plus™ Passive Needle Guard technology to reduce the risk of accidental needle sticks.
Clinical Indications and Applications
Pexegra is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-neoplastic drugs. Filra addresses a broader range of neutropenia conditions, indicated for reducing the frequency of infections manifested by febrile neutropenia in patients with non-myeloid malignancies receiving myelosuppressive antineoplastic agents, and in patients with severe congenital, idiopathic, or cyclic neutropenia.
Strategic Partnership and Market Impact
"We are delighted to bring Pexegra and Filra to patients in Canada," said Sandeep Athalye, Chief Executive Officer of Kashiv Biosciences. "Kashiv's facilities are fully prepared to support JAMP's commercialization efforts, and we look forward to working together to expand access to high-quality, affordable biosimilars worldwide."
Louis Pilon, President and CEO of JAMP Pharma Group, emphasized the significance of this launch: "We are extremely proud to add PrPexegra and PrFilra to our growing biosimilars portfolio. This marks the first oncology biosimilar products for our BioJAMP division. These launches align with our mission to provide diverse therapeutic solutions to Canadian patients and are a testament to our expertise in biosimilars."
Company Portfolio Expansion
The launch represents JAMP Pharma Group's entry into oncology through its BioJAMP division, adding to its existing biologic portfolio that includes PrSimlandi and PrJamteki in immunology. The company has demonstrated significant growth with over 130 new products authorized for sale by Health Canada in the last three years, positioning itself as the Canadian leader in product launches.
JAMP Pharma Group operates with a portfolio of more than 380 molecules and is recognized as one of the industry leaders in annual prescription volume. The company's commitment to Canadian healthcare is reinforced by its status as a Canadian-based and owned organization, contributing to both patient care and the local economy.
Regulatory Status and Availability
Both biosimilars have received authorization for sale from Health Canada. Pexegra is authorized as a preservative-free solution containing 6 mg of pegfilgrastim (10 mg/mL) in a single-dose prefilled syringe. Filra is available in preservative-free formulations with 300 mcg of filgrastim (600 mcg/mL) in 0.5 mL syringes and 480 mcg of filgrastim (600 mcg/mL) in 0.8 mL syringes, distributed in boxes of 1 and 10 syringes.
