A GaBIJ perspective article entitled ‘Ethnic sensitivity assessments in biosimilar monoclonal antibodies clinical development programmes: necessary or not?’, was published by a group of authors from Biocon Biologics in August 2023 [1].
This perspective, outlines that when a new drug goes through multi-regional/global clinical trials to be registered in multiple geographies, variability in drug exposure and response can be affected by several complex factors, such as race and ethnicity. These factors can then become a ‘rate-limiting step’ in product registration. Due to this, ethnic sensitivity assessments, in the form of bridging pharmacokinetics (PK) studies, are often needed for biosimilar monoclonal antibodies (mAbs) to meet regulatory requirements in regions such as East Asia.
However, the authors highlight that mAbs exhibit properties that make them less likely to be affected by ethnic differences, as they do not undergo traditional drug-related metabolism like liver and gut metabolism, unlike small molecule drugs. As such, the authors carried out a literature review and analysis which suggest that the ethnic sensitivity of mAbs can be determined by using the original data from previously studied population(s) without conducting additional studies. Specifically, they highlight that current literature indicates that ethnicity generally does not influence the PK, pharmacodynamics (PD), safety, and efficacy of most mAbs. For example, the recommended doses for most mAbs are similar or have no difference between non-Japanese and Japanese patients. The authors note that, despite these findings, Ethnic Sensitivity Studies (ESSs) are still routinely required for approval in territories of East Asia such as China, South Korea, and Taiwan.
In light of this, the authors argue that such requirements should be reconsidered based on the available data on the reference drug rather than being a default obligation in biosimilar development of mAbs. They propose that the ESS requirement should be removed for biosimilar mAbs, as they are highly similar to the reference products and have already demonstrated quality, safety and efficacy.
The authors recommend that regulatory authorities in East Asia consider harmonizing the legislation and guidance on ethnic sensitivity to facilitate biosimilar drug development and ensure patient access without compromising safety and efficacy requirements. They highlight that, eliminating such a requirement could accelerate the development of biosimilar drugs while maintaining safety and efficacy standards, facilitating access to these life-saving therapies across the globe.
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Reference
1. Athalye SN, Baruah DB, Mittra S, et al. Ethnic sensitivity assessments in biosimilar monoclonal antibodies clinical development programmes: necessary or not? Generics and Biosimilars Initiative Journal (GaBI Journal). 2023;12(2):61-6. doi: 10.5639/gabij.2023.1202.011
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