Global Eylea® Comparator Supply
CSI supports ophthalmology programmes requiring Eylea® comparator medicines.
Recent projects have included sourcing high quantities within a tight deadline, demonstrating our ability to support both small research studies and large multinational clinical trials.
Eylea® (aflibercept) Comparator Sourcing
The clinical supply partner of choice
Aflibercept (Eylea®) is widely used in global ophthalmology programmes, with frequent clinical-trial demand alongside other anti-VEGF therapies including ranibizumab (Lucentis®) and bevacizumab (Avastin®). CSI’s scientific team develops sourcing strategies around each protocol, securing the right presentations, markets and volumes through qualified, fully traceable supply chains—with the documentation required by QP and regulatory teams.
Our services include:
Global procurement
Sourcing across multiple markets, scaled from small research studies to multinational trials.
Cold chain distribution
GDP-compliant temperature-controlled distribution with continuous monitoring.
Documentation management
Certificates of Analysis, Batch Release Certificates and Statements of Authenticity as standard.
Inventory planning
Stock held and released against your enrolment schedule, avoiding both shortfall and overbuying.
THE CSI PROCESS
From protocol to site in six steps
Six steps, one project manager providing end-to-end support.
01
Protocol Analysis
Our scientific team reviews your protocol, designs the optimal comparator sourcing strategy tailored to your study design. You get a comprehensive clinical trial supply solution, not a price list.
02
Availability
We review all the optimal sourcing markets, batch availability, shelf life and pricing across a network of more than 200 audited manufacturers and suppliers, and remove any option where continuity is at risk.
03
Sourcing and authentication
The product is purchased with consideration of multiple factors (the number of supply runs required based on the shelf life of the product and length of your study, supply per arm and per visit schedule). These are purchased either manufacturer-direct or through the open market. Every unit is quality-checked at purchase and when it enters our depots.
04
QP release and documentation
CSI can provide Statement of Authenticity (SoAs), Certificate of Analysis (CoA) (product priced accordingly), and in some cases, BSE/TSE statements, equivalency statements, certificate of compliance, and batch-release certificate, upon request. For a fee, CSI can also provide a Certificate of Origin (CoO).
05
Cold chain delivery
CSI can handle all temperature-controlled logistics requirements, with continuous temperature monitoring and GDP-compliant handling across 61 countries on six continents.
06
Resupply and forecasting
Rolling demand forecasts, shelf-life control and batch reservation for the life of the study, with one project manager accountable from first shipment to reconciliation.
PRODUCT DETAIL
Presentations we supply
40 mg/mL
EU MA
MA (EU) number
Pharmaceutical form
Route of administration
Immediate packaging
Content (concentration)
Pack size
EU/1/12/797/001
Solution for injection
Intravitreal use
Pre-filled syringe (glass)
0.09 mL
1 pre-filled syringe
40 mg/mL
EU MA
MA (EU) number
Pharmaceutical form
Route of administration
Immediate packaging
Content (concentration)
Pack size
EU/1/12/797/002
Solution for injection
Intravitreal use
Vial (glass)
0.1 mL
1 vial + 1 filter needle
114.3 mg/mL
EU MA
MA (EU) number
Pharmaceutical form
Route of administration
Immediate packaging
Content (concentration)
Pack size
EU/1/12/797/003
Solution for injection
Intravitreal use
Vial (glass)
0.263 mL
1 vial + 1 filter needle
114.3 mg/mL
EU MA
MA (EU) number
Pharmaceutical form
Route of administration
Immediate packaging
Content (concentration)
Pack size
EU/1/12/797/004
Solution for injection
Intravitreal use
Pre-filled syringe (glass)
0.184 mL
1 pre-filled syringe
COLD CHAIN
CSI supports all temperature requirements
Aflibercept ships at 2 to 8°C, but a comparator programme rarely ships one product alone. CSI validates the full range so combination and concomitant supply moves together.
15–25°C
AMBIENT
Qualified logistics partners, continuous temperature monitoring and excursion reporting, GDP-compliant end to end.
2 to 8°C
REFRIGERATED
Qualified shippers, continuous temperature monitoring and excursion reporting, GDP-compliant end to end.
−20°C
FROZEN
Fully audited shippers, continuous temperature monitoring and excursion reporting, GDP-compliant end to end.
−80°C
ULTRA-LOW
Qualified shippers, continuous temperature monitoring and excursion reporting, GDP-compliant end to end.
Why sponsors choose CSI
150+ years of clinical trial supply experience and a scientific team that reads the protocol before it quotes.
Over 1,200 clinical trials supported
Direct relationships with 200+ manufacturers
Dedicated scientific project management team
Expertise in oncology, biosimilars, immunology and ophthalmology
Access to 15,000+ medicines
Warehousing and distribution across 61 countries
GDP-compliant cold chain at every temperature
Full regulatory documentation with every shipment
Documentation
CoAs can be supplied upon request, in the language your regulatory submission requires. Products supplied with a CoA may be subject to higher costs.
Formal confirmation that the batch was released for supply in its licensed source market under the manufacturer's quality system. Upon request, this can be supplied alongside the Certificate of Analysis, so your QP can trace release back to the licensed market.
A signed declaration that the product is genuine and was acquired through the licensed supply chain. This is the assurance against falsified or diverted product when a comparator is bought on the open market.
Monitoring data for every shipment, reported and assessed for impact on product quality. You receive the record whether or not an excursion occurs.
CASE STUDY
Rapid Eylea Ophthalmology Study Supply
Also read: Securing Long-Term, Cost-Effective Supply of Eylea EU & USA for programs of studies
Also read: Securing Long-Term, Cost-Effective Supply of Eylea EU & USA for programs of studies
Challenge
To source 400 packs of aflibercept from the open market for a CRO’s trial – within a tight deadline and during a holiday period
Solution
Effective communication and coordination between CSI, the client, a local vendor and CSI’s warehouse ensured smooth delivery
Result
The required quantity of medication was successfully delivered to CSI’s warehouse for immediate distribution to hospitals
APPLICATIONS
Where sponsors use Eylea® as comparator
Oncology
Comparator and standard-of-care supply for solid tumour and haematology programmes across all phases.
Immunotherapy
Checkpoint inhibitor sourcing for combination and head-to-head study designs.
Biosimilar development
Originator reference product sourced to meet regional regulatory requirements.
FAQ
Eylea® sourcing, answered
Can CSI supply aflibercept (Eylea®) as a comparator for a global study?
Yes. CSI sources Eylea® for ophthalmology trials across Europe, North America, Latin America and Asia-Pacific. Our scientific team reviews your protocol, models quantities and builds a country-by-country sourcing strategy before any purchase is committed.
Which presentations of aflibercept are available?
Presentations vary by source market and are confirmed against your protocol before quotation. Price, expiry and availability are confirmed prior to the receipt of a Purchase Order.
How long does comparator sourcing for aflibercept take?
Every study is different, and sourcing timelines depend on your specific requirements, market, quantity and documentation needs. Send us your study requirements and product details, and we will assess what is possible for your programme. Where a study is at risk, CSI has compressed sourcing timelines by working directly with manufacturers.
What documentation is supplied with the product?
The availability of supporting documentation depends on the country from which the product is sourced and the specific requirements of the study. Where available, CSI can provide documentation such as Certificates of Analysis and country-specific regulatory documentation at an additional cost.
How is cold chain managed for aflibercept?
Aflibercept is shipped at 2-8 °C with continuous temperature monitoring, through GDP-compliant depots in 61 countries. CSI also manages -20 °C and -80 °C requirements for other components of your study.
Send us the protocol, the markets and the timeline. Our scientific team will come back with a sourcing strategy for your Eylea® requirements.
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