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

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Sunshine Biopharma's Nora Pharma has received Health Canada approval for Niopeg(R), a Biosimilar of Neulasta(R). Nora Pharma, a subsidiary of Sunshine Biopharma, has successfully obtained approval from Health Canada for the commercialization of Niopeg(R), a pegylated form of filgrastim, in Canada. Niopeg(R) is a Biosimilar comparable to Neulasta(R), indicated to decrease infection incidence in patients with non-myeloid malignancies. This approval marks a significant milestone for Nora Pharma's mission to provide high-quality affordable medicines to Canadian patients.
Nora Pharma, una sussidiaria di Sunshine Biopharma, ha ricevuto l'approvazione da Health Canada per Niopeg(R), un biosimilare di Neulasta(R). Nora Pharma ha ottenuto con successo l'approvazione per la commercializzazione di Niopeg(R), una forma pegilata di filgrastim, in Canada. Niopeg(R) è un biosimilare comparabile a Neulasta(R), indicato per ridurre l'incidenza di infezioni in pazienti affetti da tumori non mieloidi. Questa approvazione rappresenta un traguardo significativo per la missione di Nora Pharma di fornire farmaci di alta qualità e accessibili ai pazienti canadesi.
Nora Pharma, una subsidiaria de Sunshine Biopharma, ha recibido la aprobación de Health Canada para Niopeg(R), un biosimilar de Neulasta(R). Nora Pharma ha logrado con éxito la aprobación para la comercialización de Niopeg(R), una forma pegilada de filgrastim, en Canadá. Niopeg(R) es un biosimilar comparable a Neulasta(R), indicado para disminuir la incidencia de infecciones en pacientes con malignidades no mieloides. Esta aprobación marca un hito importante en la misión de Nora Pharma de proporcionar medicamentos asequibles y de alta calidad a los pacientes canadienses.
샤인샤인 바이오파마의 자회사인 노라 파마가 캐나다 보건부로부터 뉴라스타(R)의 바이오시밀러인 니오펙(R)에 대한 승인을 받았습니다. 노라 파마는 캐나다에서 필그라스팀의 페길화 형태인 니오펙(R)의 상업화에 대한 승인을 성공적으로 얻었습니다. 니오펙(R)은 뉴라스타(R)와 비교할 수 있는 바이오시밀러로, 비골수성 종양을 가진 환자에서 감염 발생률을 감소시키는 것으로 지시되어 있습니다. 이 승인은 캐나다 환자들에게 고품질의 저렴한 의약품을 제공하려는 노라 파마의 사명에 있어 중요한 이정표입니다.
Nora Pharma, une filiale de Sunshine Biopharma, a reçu l'approbation de Santé Canada pour Niopeg(R), un biosimilaire de Neulasta(R). Nora Pharma a réussi à obtenir l'approbation de Santé Canada pour la commercialisation de Niopeg(R), une forme pegylée de filgrastime, au Canada. Niopeg(R) est un biosimilaire comparable à Neulasta(R), indiqué pour réduire l'incidence des infections chez les patients atteints de malignités non-myéloïdes. Cette approbation représente une étape significative dans la mission de Nora Pharma de fournir des médicaments abordables et de haute qualité aux patients canadiens.
Nora Pharma, eine Tochtergesellschaft von Sunshine Biopharma, hat von Health Canada die Genehmigung für Niopeg(R), ein Biosimilar von Neulasta(R), erhalten. Nora Pharma hat erfolgreich die Genehmigung von Health Canada für die Vermarktung von Niopeg(R), einer pegylierten Form von Filgrastim, in Kanada erhalten. Niopeg(R) ist ein mit Neulasta(R) vergleichbares Biosimilar, das zur Verringerung der Infektionshäufigkeit bei Patienten mit nicht-myeloischen Malignomen angezeigt ist. Diese Genehmigung markiert einen bedeutenden Meilenstein in der Mission von Nora Pharma, kanadischen Patienten hochwertige, erschwingliche Medikamente zu bieten.
Positive
  • Nora Pharma, a subsidiary of Sunshine Biopharma, has received Health Canada approval for the commercialization of Niopeg(R), a Biosimilar of Neulasta(R).
  • Niopeg(R) is a pegylated form of filgrastim indicated to decrease infection incidence in patients with non-myeloid malignancies.
  • The current market size of pegfilgrastim in Canada is approximately $88 million USD.
  • Niopeg(R) is available in a pre-filled syringe of 6 mg/0.6 mL.
  • Malek Chamoun, president of Nora Pharma, expressed the company's commitment to being a leader in the pharmaceutical sector with the launch of Niopeg(R).
  • Dr. Steve Slilaty, CEO of Sunshine Biopharma, highlighted the importance of Niopeg(R) in preventing infections in patients with non-myeloid cancers, such as breast cancer, and its contribution to shareholder value.
Negative
  • None.

The approval of NIOPEG® by Health Canada represents a strategic entry into the biosimilars market for Nora Pharma, a subsidiary of Sunshine Biopharma. Biosimilars, being cost-effective alternatives to expensive biologics, have the potential to capture significant market shares, especially in cost-sensitive healthcare markets like Canada. Considering the $88 million USD market size for pegfilgrastim in Canada, NIOPEG®, as a pegylated form of filgrastim, could tap into this existing market, potentially increasing Sunshine Biopharma's revenue streams. Biosimilar competition typically leads to lower prices, which can result in increased adoption and market penetration. However, the extent of impact on Sunshine Biopharma's bottom line will depend on the pricing strategy, market acceptance and competitive response from other market players in the therapeutic space.

Health Canada's approval is a rigorous process that assesses the safety, efficacy and quality of pharmaceuticals. NIOPEG® clearing this hurdle is a testament to the drug's potential in meeting the standards set for biosimilars. It’s important to note that biosimilars must demonstrate no clinically meaningful differences from the originator product, which in this case is NEULASTA®. For Sunshine Biopharma, this approval opens the door to the Canadian market but also sets a precedent that could streamline approvals in other jurisdictions. Investors should monitor the company's execution of its go-to-market strategy and post-marketing commitments, as these factors could influence the drug's commercial success and, by extension, shareholder value.

Febrile neutropenia is a serious complication of chemotherapy, making drugs like pegfilgrastim important in oncology supportive care. With the approval of NIOPEG®, Sunshine Biopharma addresses a critical need for patients undergoing myelosuppressive chemotherapy. The therapeutic effectiveness of NIOPEG® in reducing infection incidence will play a central role in its uptake. For investors considering the oncology sector, the key metrics to follow would be the adoption rate among oncologists and patient outcomes. Additionally, the impact on healthcare economics, including potential cost-savings for the Canadian healthcare system, could encourage broader use and reinforce Sunshine Biopharma's market position.

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: www.sunshinebiopharma.com.

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
camille.sebaaly@sunshinebiopharma.com

SOURCE: Sunshine Biopharma, Inc.



View the original press release on accesswire.com

FAQ

What Biosimilar product has Nora Pharma received Health Canada approval for?

Nora Pharma has received Health Canada approval for the commercialization of Niopeg(R), a Biosimilar of Neulasta(R).

What is the current market size of pegfilgrastim in Canada?

The current market size of pegfilgrastim in Canada is approximately $88 million USD.

What is Niopeg(R) indicated for?

Niopeg(R) is indicated to decrease the incidence of infection in patients with non-myeloid malignancies receiving myelosuppressive anti-neoplastic drugs.

Who is the president of Nora Pharma?

Malek Chamoun is the president of Nora Pharma.

Who is the CEO of Sunshine Biopharma?

Dr. Steve Slilaty is the CEO of Sunshine Biopharma.

Sunshine Biopharma, Inc.

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