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Sunshine Biopharma Launches NIOPEG(R) Into $10 Billion Biologics Market

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Sunshine Biopharma (NASDAQ:SBFM) has announced the launch of NIOPEG®, its first biosimilar drug, through its Canadian subsidiary Nora Pharma. NIOPEG® is comparable to NEULASTA® (Pegfilgrastim) and is designed to reduce infection risk in chemotherapy patients with non-myeloid malignancies.

The global market for NEULASTA® and its biosimilars was valued at $4.5 billion in 2024, with projections to reach $9.2 billion by 2033, growing at a CAGR of 8.5%. In Canada, where biologic drug sales reached $10 billion in 2020, the market represents a significant opportunity due to high per capita biologics spending and favorable provincial switching policies.

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Positive

  • Entry into the high-value biologics market with NIOPEG® biosimilar
  • Target market projected to grow from $4.5B to $9.2B by 2033 (8.5% CAGR)
  • Strategic expansion into Canadian market with high per capita biologics spending
  • Favorable market conditions due to provincial switching policies encouraging biosimilar adoption

Negative

  • Entering a competitive market dominated by established NEULASTA® brand
  • Canadian market represents only a small portion of the global opportunity

News Market Reaction – SBFM

+13.79%
+13.79% Session move

In the trading session that priced this news, SBFM gained 13.79%, reflecting a significant positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

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FORT LAUDERDALE, FL / ACCESS Newswire / July 2, 2025 / Sunshine Biopharma Inc. (NASDAQ:SBFM) (the "Company"), a pharmaceutical company offering and researching life-saving medicines in a variety of therapeutic areas including oncology and antivirals today announced that its wholly owned Canadian subsidiary, Nora Pharma Inc., has launched NIOPEG®, the Company's first Biosimilar drug on the market.

NIOPEG® is a Biosimilar comparable to the reference biologic drug NEULASTA® (Pegfilgrastim). Like NEULASTA®, NIOPEG® is a long-acting, pegylated form of recombinant human granulocyte colony-stimulating factor (filgrastim). It is indicated to decrease the incidence of infection in patients with non-myeloid malignancies receiving chemotherapy. NIOPEG® is available in a prefilled syringe of 6mg/0.6mL.

As of 2024, the global market size for NEULASTA® and its biosimilars was estimated at $4.5 billion, with projections suggesting it could reach $9.2 billion by 2033, growing at a compound annual growth rate (CAGR) of 8.5% (Verified Market Reports). The growth is largely driven by rising global cancer incidence and chemotherapy use.

The Canadian market for NEULASTA® and its Biosimilars is smaller but still significant due to high biologics spending. Biologic drug sales in Canada reached $10 billion in 2020, accounting for about one-third of total pharmaceutical spending (www.canada.ca). NEULASTA® is one of the key biologics used in oncology, and its biosimilars have been gaining traction, especially after provincial switching policies were introduced to encourage cost savings.

Although Canada represents a smaller slice of the global market, its per capita biologics spending ranks among the highest in the OECD (Organisation for Economic Co-operation and Development), making it a valuable market for both branded and biosimilar products.

"The launch of NIOPEG® as a biosimilar to NEULASTA® represents a strategic milestone in our growth trajectory," said Dr. Steve Slilaty, CEO of Sunshine Biopharma. 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."

About Sunshine Biopharma Inc.

Sunshine Biopharma currently has 72 generic prescription drugs on the market in Canada and more than 12 additional drugs planned to be launched in the remainder of 2025. In addition, Sunshine Biopharma is conducting a proprietary drug development program which is comprised of (i) K1.1 mRNA, an mRNA-Lipid Nanoparticle targeted for liver cancer, and (ii) PLpro protease inhibitor, a small molecule for treatment of SARS Coronavirus infections. For more information, please visit: www.sunshinebiopharma.com.

All registered trademarks are the property of their respective owners.

Safe Harbor Forward-Looking Statements

This press release contains forward-looking statements which are based on current expectations, forecasts, and assumptions of Sunshine Biopharma Inc. (the "Company") that involve risks as well as uncertainties that could cause actual outcomes and results to differ materially from those anticipated or expected. These statements appear in this release and include all statements that are not statements of historical fact regarding the intent, belief or current expectations of the Company, including statements related to the Company's drug development activities, financial performance, and future growth. These risks and uncertainties are further described in filings and reports by the Company with the U.S. Securities and Exchange Commission (SEC). Actual results and the timing of certain events could differ materially from those projected in or contemplated by the forward-looking statements due to a number of factors detailed from time to time in the Company's filings with the SEC. Reference is hereby made to cautionary statements and risk factors set forth in the Company's most recent SEC filings.

For more information, please contact:

Camille Sebaaly, CFO
Direct Line: 514-814-0464
camille.sebaaly@sunshinebiopharma.com

SOURCE: Sunshine Biopharma Inc.



View the original press release on ACCESS Newswire

FAQ

What is Sunshine Biopharma's (SBFM) NIOPEG® and what is it used for?

NIOPEG® is a biosimilar to NEULASTA® (Pegfilgrastim), used to decrease infection risk in chemotherapy patients with non-myeloid malignancies. It's available in a 6mg/0.6mL prefilled syringe.

How big is the market opportunity for SBFM's NIOPEG®?

The global market for NEULASTA® and biosimilars was $4.5 billion in 2024 and is projected to reach $9.2 billion by 2033, growing at 8.5% CAGR.

What is the size of the Canadian biologics market where NIOPEG® launched?

Canadian biologic drug sales reached $10 billion in 2020, representing about one-third of total pharmaceutical spending in the country.

How does NIOPEG® fit into Sunshine Biopharma's business strategy?

NIOPEG® represents a strategic milestone for SBFM, expanding their portfolio into the high value-added biologics market with a cost-effective alternative, creating new revenue streams.

What are the growth drivers for NIOPEG's target market?

The market growth is primarily driven by rising global cancer incidence and increased chemotherapy use, with additional support from provincial switching policies in Canada.