Sunshine Biopharma Launches NIOPEG® Biosimilar in Canada, Targeting $10B Biologics Market
Sunshine Biopharma Inc. (NASDAQ: SBFM), a pharmaceutical company focused on developing and commercializing life-saving medicines across oncology, antiviral therapies, and other therapeutic areas, has announced the commercial launch of its first biosimilar drug, NIOPEG®, in Canada. The launch was executed through its wholly owned Canadian subsidiary, Nora Pharma Inc., and marks Sunshine Biopharma’s entry into the rapidly expanding global biologics and biosimilars market.
NIOPEG® is a biosimilar of NEULASTA® (pegfilgrastim), a long-acting, pegylated form of recombinant human granulocyte colony-stimulating factor (G-CSF), indicated for reducing the risk of infection in cancer patients with non-myeloid malignancies undergoing chemotherapy. It functions by stimulating the production of white blood cells, thus helping patients recover faster from neutropenia, a common side effect of chemotherapy. NIOPEG® is offered in a convenient prefilled syringe format, delivering 6 mg of active drug in 0.6 mL.
The global market for NEULASTA® and its biosimilars is substantial. In 2024, it was valued at approximately $4.5 billion, and is projected to nearly double to $9.2 billion by 2033, growing at a compound annual growth rate (CAGR) of 8.5%, according to Verified Market Reports. The increasing global incidence of cancer and expanding use of chemotherapy continue to drive demand for supportive care drugs such as pegfilgrastim.
While the Canadian market is smaller in scale, it remains an attractive and strategically important segment. Biologic drug sales in Canada reached $10 billion in 2020, representing nearly one-third of all pharmaceutical expenditures in the country, according to Health Canada. Pegfilgrastim-based biologics like NEULASTA® are widely prescribed in oncology treatment regimens and have been among the top biologic expenditures. In recent years, provincial switching policies favoring biosimilars have accelerated their uptake, creating opportunities for cost-effective alternatives like NIOPEG® to penetrate the market.
Importantly, Canada also ranks among the highest per capita spenders on biologic medicines within the OECD (Organisation for Economic Co-operation and Development), highlighting its potential value for biosimilar manufacturers. The launch of NIOPEG® positions Sunshine Biopharma to capitalize on this dynamic environment by providing an affordable, clinically equivalent option for Canadian oncologists and their patients.
Dr. Steve Slilaty, CEO of Sunshine Biopharma, emphasized the significance of the launch, stating:
“The launch of NIOPEG® as a biosimilar to NEULASTA® represents a strategic milestone in our growth trajectory. By entering the high value-added biologics market with a cost-effective and clinically equivalent alternative, we are strengthening our portfolio, expanding our addressable market, and creating new revenue streams. This reinforces our commitment to delivering sustainable value to patients, the healthcare system, and our shareholders alike.”
The commercialization of NIOPEG® underscores Sunshine Biopharma’s broader strategy to diversify beyond its research-driven roots and build a robust pipeline of marketed products. It also reflects growing investor and industry interest in biosimilars, as governments, payers, and providers seek ways to reduce the high cost of biologics while maintaining quality care.
With its Canadian biosimilar debut now underway, Sunshine Biopharma is expected to explore additional markets and indications, further leveraging Nora Pharma’s infrastructure and expertise in pharmaceutical distribution. The company’s entry into the biologics segment also sets the stage for future launches of biosimilar and specialty products as it continues to expand its footprint in oncology and other high-impact therapeutic areas.
