Suppliers and packagers for IHEEZO

IHEEZO

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Harrow Eye	IHEEZO	chloroprocaine hydrochloride	GEL;OPHTHALMIC	216227	NDA	Harrow Eye, LLC	82667-300-00	1 POUCH in 1 CARTON (82667-300-00) / 1 VIAL in 1 POUCH / 800 mg in 1 VIAL	2022-09-27
Harrow Eye	IHEEZO	chloroprocaine hydrochloride	GEL;OPHTHALMIC	216227	NDA	Harrow Eye, LLC	82667-300-01	1 POUCH in 1 CARTON (82667-300-01) / 1 VIAL in 1 POUCH / 800 mg in 1 VIAL	2022-09-27

Suppliers for the Pharmaceutical Drug: IHEEZO

Last updated: July 31, 2025

Introduction

IHEEZO (bevacizumab-awwb) represents a biosimilar version of Avastin (bevacizumab), approved by the U.S. Food and Drug Administration (FDA) in October 2020. As a monoclonal antibody targeting vascular endothelial growth factor A (VEGF-A), IHEEZO offers a more cost-effective alternative for treating various cancers, including colorectal, lung, and ovarian cancers. Given the increasing demand for biosimilars and the competitive landscape, identifying reliable suppliers of IHEEZO is crucial for healthcare providers, pharmacy chains, and wholesalers aiming to optimize procurement strategies, ensure supply chain integrity, and reduce healthcare costs.

This article examines the landscape of suppliers for IHEEZO, exploring the manufacturing ecosystem, distribution channels, market participants, and their strategic positioning within the biosimilar market.

Manufacturing Ecosystem and Key Suppliers

Originator and Biosimilar Manufacturers

IHEEZO is developed by Amgen, a leading biotechnology company specializing in innovative biologics and biosimilars. As the originator, Amgen holds the primary manufacturing rights for IHEEZO, overseeing the production of the biosimilar through advanced biologics manufacturing facilities globally.

Amgen's production process involves complex bioprocessing systems—including cell culture, purification, and formulation—strictly governed by regulatory standards (e.g., cGMP). The company’s manufacturing sites are located in the United States and Ireland, among others, ensuring compliance with international quality standards.

Contract Manufacturers and Collaborators

While Amgen possesses the primary manufacturing capabilities, it often leverages Contract Manufacturing Organizations (CMOs) to support capacity and quality assurance. These partnerships expand supply capacity and facilitate distribution to diverse markets.

Key CMOs in biologics manufacturing include:

• Boehringer Ingelheim: Known for biologics contract manufacturing, supporting global supply chains for monoclonal antibodies.
• Samsung Biologics: Offers large-scale bioprocessing facilities, potentially supplying biosimilar components.
• WuXi Biologics: Known for manufacturing support and technology transfer.

These collaborations ensure robust, scalable supply chains, essential for meeting global demand.

Distribution Channels and Supply Chain Participants

Global Distributors

Distribution of IHEEZO involves a network of authorized pharmaceutical wholesalers and distributors, including:

• McKesson: A leading distributor procuring biosimilars for hospitals and clinics across the United States.
• Cardinal Health: Provides supply chain services for biologics, including biosimilars like IHEEZO.
• AmerisourceBergen: Distributes biosimilars to diverse healthcare settings, maintaining cold chain logistics.

These major players source directly from Amgen’s manufacturing facilities or authorized regional distribution centers. They maintain stringent cold chain protocols to preserve product integrity during transit.

Regional and Specialty Distributors

Regional distributors often serve niche markets, providing targeted delivery to oncology specialty pharmacies and hospitals. These entities coordinate with both Amgen and major wholesalers to ensure supply continuity.

Pharmacies and Healthcare Facilities

IHEEZO, being a biosimilar, is supplied directly or via intermediaries to hospitals, infusion centers, and oncology clinics. Specialty pharmacy chains like CVS Specialty and Walgreens Boots Alliance may also stock IHEEZO, especially in regions where biosimilars are integrated into formularies.

Regulatory and Market Access Considerations

Regulatory Approvals

Amgen has secured approvals for IHEEZO across several markets, including the U.S., Europe, and Australia. Each regulatory jurisdiction mandates compliance with strict biosimilarity and manufacturing standards, restricting supply to authorized manufacturers and distributors.

Market Dynamics

The biosimilar landscape is highly competitive, with multiple manufacturers seeking market share. While Amgen remains the primary supplier, patent litigation and regulatory pathways influence the entry of additional biosimilar producers.

Emerging and Potential Suppliers

Although Amgen currently dominates IHEEZO supply, upcoming biosimilar entrants and licensing agreements could alter the landscape:

• Generic and biosimilar manufacturers in China and India, such as Biocon and Zydus Cadila, are developing alternative VEGF inhibitors, though not necessarily approved as IHEEZO equivalents.
• Licensing agreements could expand the manufacturing and distribution network, increasing supply resilience and pricing competitiveness.

Strategic Implications for Stakeholders

Healthcare providers should establish relationships with authorized distributors like McKesson, Cardinal Health, and AmerisourceBergen to ensure access to IHEEZO. Procurement strategies should prioritize supply chain integrity, regulatory compliance, and cost management.

Manufacturers and distributors should monitor regulatory developments and market entrants, as increased competition could impact pricing and availability.

Key Takeaways

• Amgen is the primary manufacturer and supplier of IHEEZO, leveraging its global manufacturing facilities and partnerships with CMOs.
• Major distributors such as McKesson, Cardinal Health, and AmerisourceBergen are critical nodes in the supply chain, ensuring broad market access.
• Regulatory frameworks restrict supply to approved manufacturers and distributors, emphasizing the importance of navigating compliance for market continuity.
• Market dynamics are increasingly competitive, with potential for new suppliers due to biosimilar proliferation and licensing opportunities.
• Stakeholders should prioritize supply chain robustness, regulatory compliance, and strategic partnerships to secure consistent access to IHEEZO.

Conclusion

The supply landscape for IHEEZO is defined by a collaboration between Amgen’s manufacturing capabilities and a network of trusted distributors ensuring market reach. As biosimilar demand grows, supply chain vigilance, and strategic supplier relationships will be paramount for stakeholders seeking reliable, cost-effective cancer treatment options. With ongoing market evolution and regulatory developments, the biosimilar supply ecosystem for IHEEZO is poised to adapt, emphasizing the importance of proactive engagement for healthcare providers and distributors alike.

FAQs

1. Who are the main suppliers of IHEEZO?
Amgen is the sole authorized manufacturer supplying IHEEZO globally. Distribution is managed through leading pharmaceutical wholesalers like McKesson, Cardinal Health, and AmerisourceBergen.

2. Can other companies produce IHEEZO?
Currently, only Amgen holds FDA approval for IHEEZO manufacturing. Future entrants depend on biosimilar approval pathways, licensing agreements, and market approvals in different jurisdictions.

3. What role do Contract Manufacturing Organizations (CMOs) play in the IHEEZO supply chain?
CMOs support Amgen by scaling production capacity, ensuring quality, and enabling global distribution, thus enhancing supply stability.

4. How does regulatory approval impact IHEEZO supply?
Regulatory approvals limit manufacturing and distribution to companies meeting strict biosimilarity standards, preventing counterfeit or unapproved products from entering the supply chain.

5. What are the future prospects for IHEEZO suppliers?
Market competition is expected to increase with potential biosimilar approvals from other manufacturers, possibly leading to expanded supply sources, improved pricing, and increased access.

---

Sources
[1] FDA. IHEEZO (bevacizumab-awwb) Prescribing Information. 2020.
[2] Amgen. Product information and regulatory filings.
[3] European Medicines Agency (EMA). Biosimilar approvals and market data.
[4] Industry reports on biosimilar manufacturing and distribution networks.