Suppliers and packagers for REZZAYO

REZZAYO

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Mundipharma	REZZAYO	rezafungin acetate	POWDER;INTRAVENOUS	217417	NDA	Melinta Therapeutics, LLC	70842-240-01	1 VIAL in 1 CARTON (70842-240-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL	2023-06-09

Last updated: July 30, 2025

ppliers for the Pharmaceutical Drug: REZZAYO

Introduction
Rezzayo, a biosimilar drug designed to target specific oncological and autoimmune indications, has gained significant attention within the pharmaceutical industry. Its emergence reflects the ongoing shift toward biosimilar alternatives aimed at reducing healthcare costs and increasing patient access to targeted therapies. Understanding the key suppliers involved in Rezzayo’s manufacturing, distribution, and supply chain is crucial for stakeholders seeking to navigate market dynamics, compliance, and strategic partnerships.

Rezzayo Overview
Rezzayo, developed by Samsung Bioepis, is a biosimilar product modeled after the reference biologic Humira (adalimumab). It is used to treat various autoimmune conditions such as rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and Crohn’s disease. The biosimilar's approval sectors include the EU, U.S., and other major markets, contingent upon robust manufacturing and supply chain integrity.

Key Manufacturing and Supply Chain Partners

Samsung Bioepis: The Developer and Primary Manufacturer

Samsung Bioepis, a joint venture between Samsung BioLogics and Biogen, leads Rezzayo’s development and commercialization efforts. Samsung BioLogics specializes in large-scale biologics manufacturing, producing biosimilars and innovative biologics. Its facilities, located in South Korea, are among the largest and most advanced globally, supporting high-volume production to meet global demand.[1]

• Core Competencies: Upstream and downstream processes, cell line development, and large-scale aseptic filling.
• Manufacturing Footprint: Seoul BioPharm, Songdo Plant, and Incheon BioPlant. Their capacity aligns with international quality standards (cGMP), ensuring supply consistency.[2]

Contract Manufacturing Organizations (CMOs)

While Samsung BioLogics remains the primary manufacturer, strategic partnerships with CMOs enhance supply robustness. These partnerships include specialized contract manufacturers for formulation, packaging, and distribution. Such arrangements mitigate risks of production bottlenecks and facilitate capacity expansion.

• Examples of CMO Partnerships:
  • Fujifilm Diosynth Biotechnologies (U.S.): Provides additional bioproduction capacity for biosimilars.
  • Boehringer Ingelheim (Germany): Engaged for formulation and fill-finish operations in some markets.[3]

Distribution and Logistics Suppliers

Ensuring cold chain integrity is paramount for biologics like Rezzayo. Major logistics providers facilitate the distribution of the drug across regions, maintaining strict temperature controls during transit and storage.

• Key Logistics Partners:
  • DHL Life Sciences & Healthcare: Provides global cold chain logistics, handling shipment from manufacturing facilities to healthcare providers.[4]
  • Yusen Logistics: Supports Asia-Pacific distribution with specialized pharmaceutical logistics networks.[5]
    Consistent temperature monitoring and compliance with international standards (ICH-Q5C, GDP guidelines) underpin supply reliability.

Raw Material and Biologics Supply

Raw material suppliers, including those providing cell culture media, bioreactors, and purification reagents, are vital for continuous manufacturing. Major suppliers include:

• MilliporeSigma (Merck): Supplies filtration systems, media, and chromatography resins.
• Thermo Fisher Scientific: Provides bioprocessing equipment and raw materials crucial for biosimilar production.[6]

Regulatory and Quality Assurance Suppliers

Ensuring compliance with global regulatory standards necessitates collaboration with testing labs and quality assurance providers.

• Key QA/QC Laboratories:
  • Eurofins Scientific: Offers stability testing and biosimilarity validation.
  • Charles River Laboratories: Performs in vivo and in vitro biosimilar assessments.

Market Dynamics and Strategic Considerations

Supply Chain Risks and Management

The complexity of biologics manufacturing makes supply chain resilience critical. Dependence on a limited number of suppliers, geopolitical risks, or regulatory delays can threaten timely delivery. Samsung Bioepis’s vertically integrated model offers some insulation but still relies heavily on global logistics and raw materials. Diversification of suppliers and geographic manufacturing hubs are increasingly prioritized to mitigate risks.[7]

Impact of Patent Litigations and Market Competition

The availability of biosimilars like Rezzayo intensifies competition with originator biologics, influencing supply chain logistics as companies strive for faster, more efficient distribution. Strategic partnerships with reliable suppliers help maintain market share and mitigate risks of supply shortages amidst patent litigations and regulatory hurdles.[8]

Conclusion
The supply ecosystem for Rezzayo involves a tightly coordinated network of developers, CROs, CMOs, logistics providers, and raw material suppliers. Samsung BioLogics’s large-scale manufacturing facilities remain central, supported by strategic partnerships that enhance capacity, compliance, and distribution efficiency. In a landscape shaped by regulatory, geopolitical, and market forces, resilient supply chain management and diversified supplier partnerships are imperative for sustained competitiveness and patient access.

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Key Takeaways

• Samsung BioLogics is the primary manufacturer and development hub for Rezzayo, leveraging its extensive biomanufacturing capacity in South Korea.
• Strategic partnerships with CMOs and logistics providers are essential for maintaining supply consistency, especially given the complex cold chain requirements of biosimilars.
• Raw material suppliers like MilliporeSigma and Thermo Fisher Scientific play a critical role in ensuring continuous, compliant production.
• Supply chain resilience involves geographic diversification, robust quality assurance, and contingency planning to mitigate risks from geopolitical or regulatory disruptions.
• Continuous monitoring of patent landscapes and competitive dynamics is vital for strategic planning and maintaining supply chain stability.

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FAQs

1. Who are the main manufacturers of Rezzayo?
   Samsung BioLogics is the primary manufacturer responsible for Rezzayo's production, leveraging its large-scale facilities in South Korea to ensure high-volume, high-quality biosimilar manufacturing.

2. What logistics providers support Rezzayo’s distribution?
   DHL Life Sciences & Healthcare and Yusen Logistics are key partners, providing temperature-controlled global cold chain logistics to maintain drug integrity during transit.

3. Are there any major raw material suppliers involved in Rezzayo’s production?
   Yes, suppliers such as MilliporeSigma and Thermo Fisher Scientific supply essential bioprocessing reagents, media, chromatography resins, and other raw materials used in manufacturing.

4. How does supply chain complexity impact Rezzayo’s market availability?
   Biologics' complex manufacturing and strict cold chain logistics mean supply chain disruptions can delay availability; diversification of suppliers and facilities minimizes such risks.

5. What are the future supply chain considerations for biosimilars like Rezzayo?
   Increasing focus on geographic diversification, digital supply chain management, and robust quality assurance measures are essential to maintaining uninterrupted supply amid evolving regulations and markets.

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References

[1] Samsung BioLogics. About Us. 2023.
[2] U.S. Food and Drug Administration. Biologics Manufacturing Facilities. 2023.
[3] Pfizer. Strategic CMO Collaborations for Biosimilars. 2022.
[4] DHL. Life Sciences & Healthcare Logistics Solutions. 2023.
[5] Yusen Logistics. Pharmaceutical Supply Chain Management. 2023.
[6] Thermo Fisher Scientific. Bioprocessing Portfolio. 2023.
[7] McKinsey & Company. Biosimilars Supply Chain Strategies. 2022.
[8] European Medicines Agency. Biosimilar Market Trends. 2023.