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Sunshine Biopharma's Nora Pharma Receives Health Canada Approval for Niopeg(R), a Biosimilar of Neulasta(R)

Friday, 19 April 2024 08:00 AM

Sunshine Biopharma, Inc.

NEW YORK, NY / ACCESSWIRE / April 19, 2024 / Sunshine Biopharma Inc. (NASDAQ:SBFM), a pharmaceutical company offering and researching life-saving medicines in a variety of therapeutic areas including oncology and antivirals, is happy to announce that its wholly owned generic pharmaceutical subsidiary, Nora Pharma, has received approval for its first Biosimilar product.

Nora Pharma has received approval from Health Canada for the commercialization of NIOPEG® (a pegylated form of filgrastim) in Canada. The current market size of pegfilgrastim in Canada is approximately $88 million USD.

NIOPEG® is a Biosimilar comparable to the reference biologic drug NEULASTA® (pegfilgrastim). NIOPEG® is a long-acting form of recombinant human granulocyte colony-stimulating factor (r-HuG-CSF), or filgrastim. It is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-neoplastic drugs. NIOPEG® is available in a pre-filled syringe of 6 mg/0.6 mL.

"With this product, we demonstrate to the Canadian market our determination to be a leader in the pharmaceutical sector," said Malek Chamoun, president of Nora Pharma. "This is an important milestone for our mission of bringing high quality affordable medicines to patients across Canada," he added.

"NIOPEG® is used to help prevent infection in people with non-myeloid cancers who are receiving chemotherapy. An example of a non-myeloid cancer is breast cancer," said Dr. Steve Slilaty, CEO of Sunshine Biopharma. "We are committed to bringing continued value to our shareholders, and launching NIOPEG® is one of the ways we are doing that as we move closer and closer to profitability," he continued.

About Sunshine Biopharma Inc.

Sunshine Biopharma, through its subsidiary Nora Pharma Inc., has 52 generic prescription drugs on the market in Canada. The Company is planning to expand its product offering to a total of 60 generic prescription drugs by the end of 2024. In parallel, Sunshine Biopharma is continuing its proprietary drug development program which is comprised of (i) K1.1 mRNA for liver cancer, and (ii) PLpro protease inhibitor for SARS Coronavirus infections. For more information, please visit:

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.


® Registered trademarks are owned by the respective owner(s) of each product

For Additional Information:

Sunshine Biopharma Contact:
Camille Sebaaly, CFO
Direct Line: 332-216-1147
[email protected]

SOURCE: Sunshine Biopharma, Inc.

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