Biosimilars, are they comparable to their reference counterparts?

Biosimilares/Investigación | Posted 18/11/2022 post-comment0 Post your comment

Biologicals such as rituximab and trastuzumab have improved treatment outcomes for many cancers. However, due to their high economic burden, ‘highly similar’ products known as biosimilars have been developed and used. Yet, there is still concern surrounding comparability of efficacy and safety between the biosimilar and its reference biological, especially regarding patients switching from the reference to the biosimilar.


On this subject, Australian authors Song NK et al. investigated whether biosimilars are as promising as claimed. The authors aimed to compare the efficacy and safety of rituximab biosimilars to reference rituximab in patients with cancer. They cited clinical evidence, including a systematic review of 29 studies of comparing rituximab biosimilars and its reference product, and have found comparability in efficacy and safety which overall adds support of their use in oncology. However, they also noted that there was a knowledge gap in the group of patients who have switched from the originator to biosimilar. 

In the end, the authors recommended further investigation on appropriate biosimilar uptake strategies specifically switching between originators to biosimilars and biosimilars to biosimilars to improve clinician and patient confidence in biosimilar uptake. In Australia, improved uptake of biosimilars have already led to accelerated reduction on immunotherapy costs leading to direct patient savings but also significant savings to the health system leading to wider access to rituximab through the removal of prescribing restrictions to access drug subsidy or reimbursement [1]. 

Conflict of interest 
The authors of the research paper [1] declared that there was no conflict of interest.

Abstracted by Dr Jennifer Ong, Lecturer, Clinical Placement Coordinator, The University of Sydney School of PharmacyFaculty of Medicine and HealthBadham, Rm S503, Pharmacy and Bank Building A15, The University of Sydney, NSW 2006 Australia.

Editor’s Comment
Readers interested to learn more about the substitution and interchangeability of biosimilars are invited to visit to view the following manuscript published in GaBI Journal:

Substitution and interchangeability: time for a conversation?

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The new section of the ‘Latin American Forum’ on GaBI has been launched. The objective of this new section is to provide you with all the latest news and updates on developments of generic and biosimilar medicines in Latin America in Spanish.

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1. Song NK, Musa H, Soriano M, et al. Safety and efficacy comparisons of rituximab biosimilars to the reference product in patients with cancer: a systematic meta-analysis review. J Pharm Pract Res. 2022. doi:10.1002/jppr.1827

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