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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 ʷ®, its first biosimilar drug, through its Canadian subsidiary Nora Pharma. ʷ® 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.

Sunshine Biopharma (NASDAQ:SBFM) ha annunciato il lancio di ʷ®, il suo primo farmaco biosimilare, tramite la sua controllata canadese Nora Pharma. ʷ® è comparabile a NEULASTA® (Pegfilgrastim) ed è progettato per ridurre il rischio di infezioni nei pazienti sottoposti a chemioterapia con neoplasie non mieloidi.

Il mercato globale di NEULASTA® e dei suoi biosimilari è stato valutato 4,5 miliardi di dollari nel 2024, con previsioni di raggiungere 9,2 miliardi di dollari entro il 2033, crescendo a un CAGR dell'8,5%. In Canada, dove le vendite di farmaci biologici hanno raggiunto 10 miliardi di dollari nel 2020, il mercato rappresenta un'opportunità significativa grazie alla spesa pro capite elevata per i biologici e alle politiche provinciali favorevoli al switching.

Sunshine Biopharma (NASDAQ:SBFM) ha anunciado el lanzamiento de ʷ®, su primer medicamento biosimilar, a través de su subsidiaria canadiense Nora Pharma. ʷ® es comparable a NEULASTA® (Pegfilgrastim) y está diseñado para reducir el riesgo de infecciones en pacientes con quimioterapia para malignidades no mieloides.

El mercado global de NEULASTA® y sus biosimilares fue valorado en 4.5 mil millones de dólares en 2024, con proyecciones de alcanzar 9.2 mil millones de dólares para 2033, creciendo a una Tasa de Crecimiento Anual Compuesta (CAGR) del 8.5%. En Canadá, donde las ventas de medicamentos biológicos alcanzaron 10 mil millones de dólares en 2020, el mercado representa una oportunidad significativa debido al alto gasto per cápita en biológicos y a las políticas provinciales favorables para el cambio de medicamentos.

Sunshine Biopharma (NASDAQ:SBFM)� 캐나� 자회� Nora Pharma� 통해 � 바이오시밀� 의약� ʷ®� 출시� 발표했습니다. ʷ®� NEULASTA®(페그필그라스팀)와 유사하며, 비골수성 악성종양 환자� 화학요법 � 감염 위험� 줄이� 위해 설계되었습니�.

NEULASTA® � � 바이오시밀러의 글로벌 시장은 2024� 기준 45� 달러� 평가되었으며, 2033년까지 92� 달러� 이를 것으� 예상되며, 연평� 성장�(CAGR) 8.5%� 성장하고 있습니다. 2020� 캐나다에� 생물학적 제제 매출� 100� 달러� 달하� 가운데, 1인당 생물학적 제제 지출이 높고 지� 정부� 전환 정책� 우호적이어서 � 시장은 � 기회� 제공합니�.

Sunshine Biopharma (NASDAQ:SBFM) a annoncé le lancement de ʷ®, son premier médicament biosimilaire, via sa filiale canadienne Nora Pharma. ʷ® est comparable à NEULASTA® (Pegfilgrastim) et est conçu pour réduire le risque d'infection chez les patients sous chimiothérapie atteints de tumeurs non myéloïdes.

Le marché mondial de NEULASTA® et de ses biosimilaires était évalué à 4,5 milliards de dollars en 2024, avec des projections atteignant 9,2 milliards de dollars d'ici 2033, avec un taux de croissance annuel composé (CAGR) de 8,5%. Au Canada, où les ventes de médicaments biologiques ont atteint 10 milliards de dollars en 2020, ce marché représente une opportunité importante en raison des dépenses élevées par habitant en biologiques et des politiques provinciales favorables au changement de traitement.

Sunshine Biopharma (NASDAQ:SBFM) hat die Markteinführung von ʷ®, seinem ersten Biosimilar-Medikament, über seine kanadische Tochtergesellschaft Nora Pharma bekanntgegeben. ʷ® ist vergleichbar mit NEULASTA® (Pegfilgrastim) und wurde entwickelt, um das Infektionsrisiko bei Chemotherapiepatienten mit nicht-myeloischen Malignomen zu reduzieren.

Der globale Markt für NEULASTA® und dessen Biosimilars wurde im Jahr 2024 auf 4,5 Milliarden US-Dollar geschätzt, mit Prognosen, bis 2033 auf 9,2 Milliarden US-Dollar zu wachsen, bei einer jährlichen Wachstumsrate (CAGR) von 8,5%. In Kanada, wo der Verkauf von Biologika im Jahr 2020 10 Milliarden US-Dollar erreichte, stellt der Markt aufgrund der hohen Pro-Kopf-Ausgaben für Biologika und günstiger provincialer Wechselrichtlinien eine bedeutende Chance dar.

Positive
  • Entry into the high-value biologics market with ʷ® 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

Insights

Sunshine Biopharma enters lucrative biosimilars market with ʷ®, targeting significant revenue in the growing $4.5B Pegfilgrastim segment.

Sunshine Biopharma's launch of ʷ® marks their strategic entry into the high-margin biosimilars market. This pegfilgrastim biosimilar addresses a $4.5 billion global market that's projected to grow to $9.2 billion by 2033 at a 8.5% CAGR. The timing is opportune as biosimilar adoption accelerates worldwide.

The company is targeting Canada initially - a smaller but lucrative market where biologics comprise about one-third of pharmaceutical spending ($10 billion in 2020). Provincial switching policies in Canada actively encourage biosimilar adoption to reduce healthcare costs, creating a favorable environment for ʷ®.

This launch represents a significant business model evolution for Sunshine Biopharma. By entering the biosimilars space, the company diversifies beyond research-stage assets to include marketed products with immediate revenue potential. Biosimilars typically offer higher margins than traditional generics while requiring less R&D investment than novel drugs.

The pegfilgrastim market is particularly attractive as the drug addresses chemotherapy-induced neutropenia, a side effect experienced by many cancer patients. With increasing cancer incidence driving chemotherapy use, demand for supportive care medications like ʷ® should remain robust despite pricing pressures from competing biosimilars.

From a clinical perspective, ʷ®'s introduction provides oncologists with another option for managing chemotherapy-induced neutropenia, a potentially life-threatening condition. Pegfilgrastim biosimilars have demonstrated therapeutic equivalence to the reference product NEULASTA® in clinical trials, with comparable safety profiles and efficacy in reducing febrile neutropenia incidence.

The availability of another biosimilar benefits the healthcare system in multiple ways. First, it introduces additional price competition in a category dominated by high-cost biologics. Second, it improves supply chain resilience by diversifying manufacturing sources for this critical supportive care medication.

Pegfilgrastim remains a cornerstone in supportive cancer care because it significantly reduces hospitalization rates due to neutropenic fever. The once-per-chemotherapy-cycle dosing of pegfilgrastim products like ʷ® improves patient compliance compared to daily injections required with short-acting filgrastim.

The prefilled syringe formulation (6mg/0.6mL) mentioned in the release is the standard delivery method, though the announcement doesn't specify whether ʷ® will also be available in on-body injector formats similar to NEULASTA® Onpro®, which can further improve the patient experience by eliminating return visits solely for injection administration.

FORT LAUDERDALE, FL / / 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 ʷ®, the Company's first Biosimilar drug on the market.

ʷ® is a Biosimilar comparable to the reference biologic drug NEULASTA® (Pegfilgrastim). Like NEULASTA®, ʷ® 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. ʷ® 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 (). 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 ʷ® 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: .

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
[email protected]

SOURCE: Sunshine Biopharma Inc.



View the original on ACCESS Newswire

FAQ

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

ʷ® 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 ʷ®?

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 ʷ® launched?

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

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

ʷ® 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.
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