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The ideal supply partner for biologics and biosimilar medicines
CSI has extensive experience of supplying biosimilar medicines to a wide range of clinical trials worldwide. We ensure the quality of products sourced globally, supplying the necessary quantity with the longest possible expiry dates and within the required timeframe. Our strong relationships with leading manufacturers around the world and our global network of trusted suppliers make us the ideal supply partner for biosimilars.
Biosimilars
What sets CSI apart from other suppliers?
We provide competitive quotes for medicines and ancillaries and can often guarantee the price of the product for the duration of the study with the manufacturer’s agreement
Competitive product pricing
We coordinate imports and exports globally, and have supplied over 1,000 clinical trials around the world, with the most complex so far involving no less than 17 countries
Worldwide distribution capabilities
We provide our partners with sourcing options for both biologics and biosimilars after careful evaluation of the study protocol, highlighting areas for consideration and making informed recommendations
Value-based supply solutions
We have longstanding relationships with leading manufacturers around the world and can provide fast, reliable and tailored supply solutions for any clinical trial, no matter how complex
Relationships with manufacturers
We have an in-depth understanding of the nature of biologic and biosimilar products and can provide the necessary literature and insight to facilitate discussions and targeted decisions
Scientific knowledge and expertise
The ideal clinical trial supply partner
To navigate the complex clinical trial supply chain involved with biosimilars, you need the right supply partner.
CSI can:
Purchase directly from innovator companies
Secure large quantities to supply global studies and maintain continuity of supply
Ensure product pedigree
Accommodate batch requirements and longest possible expiry dates
Source a product for analytical purposes (e.g. medicines from a specific batch)
Supply larger volumes of the required medicine following testing
Global supply and
regulatory expertise
CSI has extensive experience in sourcing medicines for biosimilar studies where the site of production has an impact on the product license. We offer reliable supply services even in countries where there are very strict government regulations in place.
CSI has depots in 60 countries – the perfect footprint to deliver biosimilars across the globe
Canada
Guatemala
Mexico
Panama
United States
Interactive map
Stability Data
Certificates of Analysis
(CofAs)
Batch Release Certificates
(BRCs)
Statements of Authenticity
(SofAs)
Beyond our outstanding access to biosimilar products, we also provide all documentation required to support clinical trials at every phase, including:
We ensure that our supply chains are short and transparent, and have extensive expertise in the complexities of cold chain supply, ensuring a continuously temperature-controlled and monitored environment throughout the entire transportation process.
Amgevita (adalimumab)
Avastin (bevacizumab)
Erbitux (cetuximab)
Eylea (aflibercept)
Darzalex (daratumumab)
Herceptin (trastuzumab)
Herzuma (trastuzumab)
Humira (adalimumab)
Imraldi (adalimumab)
Jakavi (ruxolitinib)
Keytruda (pembrolizumab)
Lucentis (ranibizumab)
Mabthera (rituximab)
Mvasi (bevacizumab)
Opdivo (nivolumab)
Remsima (infliximab)
Stelara (ustekinumab)
Tecentriq (atezolizumab)
Truxima (rituximab)
Yervoy (ipilimumab)
Yuflyma (adalimumab)
Zarzio (filgrastim)
Ziextenzo (pegfilgrastim)
Biologics and biosimilars that CSI has experience in supplying globally include:
Oncology product sourcing specialists
CSI has supplied oncology products to more than 700 studies – from generics to the most sophisticated cold chain biologics.
Biologic
Number of Studies
Phase of Trial
Geography
Pembrolizumab
50+
1, 2, 3
Europe, USA
Aflibercept
50+
1, 2, 3
Europe, USA,
Latin America
Nivolumab
50+
1, 2, 3
Global
Ipilimumab
50+
1, 2, 3
Global
Ruxolitinib
25+
2, 3
Global
What are Biologics and Biosimilars?
Biopharmaceuticals have seen significant advances in recent years, particularly with the development of biologics and biosimilars. These innovative therapies have revolutionised the treatment landscape and have become the new standard of care for various conditions such as cancer, auto-immune disorders and genetic diseases, offering enhanced efficacy and reduced side-effects in comparison to traditional small molecule drugs.
A biosimilar is a type of biologic medicine that has been developed to be highly similar and clinically equivalent to an existing approved biologic (referred to as a ‘reference medicine’ or ‘originator medicine’) in terms of structure, biological activity, immunogenicity, quality, safety and efficacy. They are in great demand and are quickly becoming the standard of care in clinical trials due to their safety, efficacy and competitive pricing.
Latest information can be found on the European Medicines Agency (EMA) website. As with any biologic medicine, details of biosimilars’ licensed indications are included in the British National Formulary (BNF).
It is important to note that biosimilars are not considered generics of biologic medicines. This is due to the small degree of variability (‘microheterogeneity’) that naturally exists in the complex structure of the active substance within and between batches.
To ensure the consistency and quality of all biological medicines, including biosimilars, UK and EU legislation upholds strict requirements.
Biosimilars FAQ
When purchasing biosimilars for use in clinical trials, the following questions are often raised:
Is the biosimilar licensed for all the indications and routes of administration required?
1
Is the biosimilar available in suitable strengths and presentations?
2
Is the administration device acceptable to the patient and are product-associated support services available?
3
CSI’s scientific knowledge and experience of supplying biologics and biosimilar medicinal products to complex global studies means we are perfectly placed to navigate these questions and help our partners to deliver successful trials.
Biologics and biosimilars that CSI has extensive experience in supplying globally
Adalimumab
Bevacizumab
Cetuximab
Aflibercept
Daratumumab
Trastuzumab
Trastuzumab
Adalimumab
Adalimumab
Ruxolitinib
Pembrolizumab
Ranibizumab
Rituximab
Bevacizumab
Nivolumab
Infliximab
Ustekinumab
Atezolizumab
Rituximab
Ipilimumab
Adalimumab
Filgrastim
Pegfilgrastim
Get in touch with a member of our experienced team today to discuss your clinical trial supply requirements
Contact us
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