Comparator Sourcing for Humira® Clinical Trials
Humira® remains one of the most widely used comparator medicines for biosimilar development. CSI has extensive experience sourcing both originator Humira® and biosimilar products including Amgevita®, Amsparity®, Hulio®, Hukyndra®, Hyrimoz®, Idacio®, Imraldi®, Yuflyma®, Hefiya® and Libmyris®across multiple markets.
Humira® (adalimumab) Comparator Sourcing
The clinical supply partner of choice
Adalimumab anchors biosimilar development programmes worldwide, and originator supply for head-to-head studies routinely outstrips the volume available through a single market. Sponsors running multi-country studies need a partner who can hold continuity of supply across regions, not a broker who can fulfill one order.
CSI's scientific team builds the sourcing strategy around your protocol: which presentations the sites require, which markets can supply them compliantly, and how far ahead the volume has to be secured. That work is what keeps a study on schedule when the market tightens. Every unit arrives with the documentation your QP and regulatory teams expect, sourced through qualified manufacturers and wholesalers inside a fully traceable chain.
We provide:
Originator sourcing
Reference product sourced through licensed channels in the markets your protocol requires.
Biosimilar sourcing
Biosimilar products sourced to meet regional regulatory requirements throughout development.
Batch management
Specific batch sourcing where the protocol requires consistency across sites and study arms.
Global distribution
Warehousing and distribution across 61 countries on six continents.
Full product traceability
A documented chain of custody from the source market to your investigator site.
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
Amgevita®
Biosimilar
Commonly supplied alongside
Methotrexate
Amsparity®
Biosimilar
Commonly supplied alongside
Methotrexate
Hulio®
Biosimilar
Commonly supplied alongside
Methotrexate
Hukyndra®
Biosimilar
Commonly supplied alongside
Methotrexate
Hyrimoz®
Biosimilar
Commonly supplied alongside
Methotrexate
Idacio®
Biosimilar
Commonly supplied alongside
Methotrexate
Imraldi®
Biosimilar
Commonly supplied alongside
Methotrexate
Yuflyma®
Biosimilar
Commonly supplied alongside
Methotrexate
Hefiya®
Biosimilar
Commonly supplied alongside
Methotrexate
Libmyris®
Biosimilar
Commonly supplied alongside
Methotrexate
COLD CHAIN
CSI supports all temperature requirements
Adalimumab ships at 2 to 8°C, but some clinical trials require more than one comparator at a time. CSI covers the full range so all supplies move 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
Humira Cost Savings Through Biosimilar Access
How CSI delivered mission impossible: sourcing specific tested batches of an expensive oncology product from several European markets.
Challenge
The client required a large quantity of Humira (adalimumab) for several studies, with high costs and limited availability pressuring budgets and timelines
Solution
CSI’s manufacturer relationships provided access to a high-quality adalimumab biosimilar, saving 50% on price with carefully coordinated supply
Result
Significant cost savings with no delays to enrolment or dosing, supported by CoAs, first-leg documents and stability data
APPLICATIONS
Where sponsors use Humira® 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
Humira® sourcing, answered
Can CSI supply both originator Humira® and adalimumab biosimilars?
Yes. CSI sources originator Humira® and adalimumab biosimilars across multiple markets, so after a comprehensive consultation, CSI can advise which presentation is optimal for your trial.
Which presentations of adalimumab 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 adalimumab take?
Every study is different, and sourcing timelines depend on your specific requirements, market, quantity and documentation needs. Send us your study requirements 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 adalimumab?
Adalimumab is shipped at 2-8 °C with continuous temperature monitoring, through GDP-compliant depots in 61 countries. CSI also manages ambient 15-25 -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 Humira® requirements.
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