Are regulatory and scientific reporting biosimilar QAs consistent and complimentary?

Biosimilars/Research | Posted 21/05/2021 post-comment0 Post your comment

Questions have been raised regarding the consistency and complementarity of reporting biosimilar quality attributes between regulatory and scientific communities. For the first time, a study published in Biologicals [1] has found that while the reporting of quality attributes (QAs) by these two sources lacks consistency, overall, they do complement one another. 

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The international research team focused their study on biosimilars of adalimumab. This is a humanized monoclonal antibody that targets tumour necrosis factor alpha (TNF-α) [2]. The originator reference product is AbbVie’s Humira®. To date, adalimumab has the largest number of approved biosimilars (with 11 approved in Europe in 2020) and the broadest spectrum of therapeutic indications among all TNF-α inhibitors. With this large number of approved biosimilars available, adalimumab was an ideal product to focus on to investigate the consistency and complementarity of reporting biosimilar quality attributes between regulatory and scientific communities.

The team looked at QA reporting in biosimilarity assessments for six adalimumab biosimilars approved by the European Medicines Agency (EMA) in European public assessment reports (EPARs) and scientific publications. They mapped the QAs according to a classification scheme which divides the QAs into structural and functional attributes and includes 77 different QAs (53 structural and 24 functional).

The team found that, for the six adalimumab biosimilars analysed, the proportion of QAs reported in EPARs and publications varied from 61%–78% of all the possible 77 QAs. The proportion of QAs consistently reported in both sources ranged from 28%– 75% among biosimilars; with functional QAs being more consistently reported (88%) than structural QAs (62%). The team suggest that this is due to functional information being more clinically relevant. Overall, the team note that, combining the information on QAs presented in both sources provided a complete reporting of the biosimilarity assessment.

It was also shown that EPARs frequently reported biosimilarity interpretation without providing test results (9–57 QAs in EPARs versus 0–8 QAs in publications). However, publications frequently reported both test results and interpretations (13–40 QAs in publications versus 0–3 QAs in EPARs). In general, the team note that, both sources frequently reported the same biosimilarity interpretation of the test result for reported QAs, while a small discrepancy in reporting the biosimilarity interpretation or the acceptance criteria was detected for some clinically relevant QAs.

The team conclude by noting that, as expected, reporting on QAs of the six biosimilars varied between EPARs and scientific sources. It is likely that this variation is partly due to the different aims of the two sources and is in line with previous findings regarding differences in reporting safety and efficacy information in regulatory reports and scientific publications. The team note that, to obtain comprehensive information on QAs for an improved understanding of how biosimilarity was established at the molecular level, both sources should be systematically consulted. Overall, for the majority of adalimumab biosimilars in the study, the reporting of the extent of information on QAs in the two sources was inconsistent but reasonably complementary. The alignment in biosimilarity interpretation demonstrated between the two sources is reassuring
for the biosimilar system.

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1. Alsamil AM, Giezen TJ, Egberts TC. Comparison of consistency and complementarity of reporting biosimilar quality attributes between regulatory and scientific communities: An adalimumab case study. 2021;69:30-7.
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of adalimumab []. Mol, Belgium: Pro Pharma Communications International; [cited 2021 May 21]. Available from: 

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