Advantages Of Sourcing Biosimilars Vs. Branded Biologics In Clinical Trials

By Catalent Experts

When planning a clinical trial, sponsors should evaluate whether commercially marketed medicines will need to be sourced for use as comparator drugs or as co-medications alongside the investigational medicinal product (IMP). These products — particularly biologics — can represent a substantial portion of a study’s overall operating costs. In some cases, these expenses can be reduced by substituting a branded biologic with an approved biosimilar. While biosimilar alternatives are not available for every originator product, an increasing number of biologics now have biosimilars approved in one or more regions, and multiple options may exist for certain therapies.

When a biosimilar is available, the study sponsor’s regulatory team must determine whether it is an appropriate substitute for the originator drug. Because biosimilars may have less clinical data available than the branded product, sponsors may need to consult with regulatory authorities to confirm their acceptability in a clinical trial context. This additional consideration can sometimes discourage teams from pursuing biosimilar options early in planning.

However, the potential advantages can be significant. Biologic drugs are often extremely costly, whereas biosimilars can offer savings of 10–20% or more. When multiple biosimilars are available, competitive pricing can further increase cost reductions. As a result, thoughtful evaluation of biosimilar options can meaningfully improve the economic efficiency of a clinical trial without compromising study objectives.