OUTSOURCING Penetration of biosimilars across Europe


There are also several complexities that we face in comparator sourcing supplies, which requires careful planning early on. Sourcing biologics for clinical trials is more


challenging due to their higher cost and limited availability. In addition, distribution to the clinical trial site is not the only requirement, as the biologic will likely need to be accompanied by markers. For example, there is little benefit in trialling Avastin (bevacizumab) for breast cancer treatment unless the antibody markers indicate the patient will respond to the treatment. Production of these markers is likely to be elsewhere to the biologic production. Multiple, unbroken cold supply chains need to be coordinated.


0–15% 15–40% >40% >70% No data


and temperature compliance tracking will only increase. The stakes are high, with losses in the millions of dollars if a biologic drug is compromised in transportation.


Multiple implication and considerations Biosimilars have several key advantages from a sourcing aspect; namely, they are cheaper and are usually more readily available. Several products have almost totally replaced branded biologics in some markets. The figure (top left) shows the penetration on Infliximab biosimilars (Remicade from Janssen) across Europe. The map shows that, in several of the large European markets, biosimilars are used more than the branded Remicade.


30 | Outsourcing in Clinical Trials Handbook


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