Streamlining Development

Future Evolution of Biosimilar Development by Application of Current Science and Available Evidence: The Developer’s Perspective

This article was published in BioDrugs on August 5, 2023 and the full text can be viewed here.


Biosimilars have been available in the USA for over a decade, and in Europe for almost two decades. In that time, biosimilars have become established in the treatment landscape for a wide range of diseases, facilitating patient access and affordability of healthcare. However, patients can still struggle to access biological therapies in some markets. There is a need to streamline the process of developing biosimilars without compromising their quality, safety, or efficacy. This opinion piece considers the efficiencies that could be achieved within the biosimilar approval process. In clinical trials for biosimilars, clinical efficacy endpoints have been shown to be less sensitive measures of biosimilarity than biochemical, biophysical, and biological functional assays. Additional clinical efficacy studies comparing potential biosimilars and reference products do not add information that is useful for regulatory purposes. Large clinical studies of biosimilars with immunogenicity endpoints are of limited value, given the quality control processes in place for all biologics, including biosimilars. The expectation for multiple-switch studies for US interchangeability designation should be reconsidered immediately, and the category should be eliminated in the future. As biosimilars are typically approved globally based on a single set of clinical trials, and all subsequent manufacturing changes are already carefully monitored by regulatory authorities, comparative pharmacokinetic testing of EU and US reference products is unnecessary. Manufacturers and regulators could take greater advantage of existing real-world evidence. Streamlining biosimilar development would enable biosimilar development of more and a wider variety of biological drugs, accelerating biosimilar development without impacting patient safety or effectiveness.

Key Points

Based on current science and experience gained with biosimilars, it is appropriate and timely to streamline biosimilar development. Such streamlining will accelerate development of biosimilars and will enable biosimilar development of more and a wider variety of biological drugs.
Comparative efficacy studies, along with clinical pharmacokinetic studies that compare US and EU reference products, do not provide meaningful information that is useful for regulatory decision-making and should not be required.
Immunogenicity concerns were raised at the inception of the biosimilar industry and have since been shown to be without foundation. If any immunogenicity studies are conducted, they should apply a risk-based approach tailored to each molecule.
The US designation of interchangeability for biosimilars is not needed, causes confusion, and should be modified immediately and eliminated in the future.
Science-based regulatory consistency will ensure high global standards for all biosimilars.