The marketing authorization and the commercialization of the first biosimilars raised an important clinical dilemma: is it safe for patients the switch from the originator to a biosimilar, and even more, is it safe the switch among biosimilars? For many years the scientific community was in doubt, as we know that a biosimilar (as the word correctly states) is never identical to the originator. Initially, clinicians took a v prudent approach and produced guidance to avoid the switch. For many years patients who started a biological agent were advised to continue with the same brand. Over the last decades, more evidence accumulated that supports the conclusion that the switch results in no harm for the patients.
A recent review of clinical studies retrieved 19 controlled trials on this hot topic, and results indicate that “These studies did not highlight significant concerns in switching between biosimilars. Therefore, switching studies seem difficult to perform and unnecessary with the body of evidence suggesting no real problems in practice coupled with stringent regulatory requirements. Monitoring the use of biosimilars in clinical practice could support clinical decision-making, rational use of biological medicines, and help to further realize possible savings.”1
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References
- Allocati, E., Godman, B., Gobbi, M., Garattini, S., & Banzi, R. (2022, August 24). Switching Among Biosimilars: A Review of Clinical Evidence. Frontiers in Pharmacology, 13. https://doi.org/10.3389/fphar.2022.917814
Disclaimers
- The material in these reviews is from various public open access sources, meant for educational and informational purposes only
- Any personal opinions expressed are those of only the author(s) and are not intended to represent the position of any organization(s)
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