I was reading the EMA's technical dossier on Nepexto where they state that:
"Nepexto was considered to be as effective as Enbrel in one main study involving 517 patients with moderate to severe rheumatoid arthritis. After treatment for 24 weeks, around 81% of patients treated with Nepexto had at least a 20% decrease in symptoms of rheumatoid arthritis, compared with 87% of those treated with Enbrel."
Based on this, I wonder what would be an acceptable difference in the effect that these biosimilar drugs generate because I believe that 6% is significantly different.
Does anyone know if the acceptable difference is a standardized parameter and what it is that standard?
Hi,
The question is short but the answer needs more details because the topic touches not only "%". Moreover discussing biosimilars please remember that batch-to-batch of original/reference biotechnological drugs like therapeutic monoclonal antibodies are only biosimilar. So batches of original monoclonals are not identical but biosimilar as well.
Hope documents will answer your question with more details:
Article Statistical Assessment of Biosimilar Products
Article Statistical considerations in biosimilar clinical efficacy t...
Article Statistical considerations for confirmatory clinical trials ...
FDA Biosimilars
https://www.fda.gov/drugs/therapeutic-biologics-applications-bla/biosimilars
Biosimilars in the EU - Information guide for healthcare
https://www.ema.europa.eu/en/documents/leaflet/biosimilars-eu-information-guide-healthcare-professionals_en.pdf
and regulations by EMA
https://www.ema.europa.eu/en/human-regulatory-overview/research-and-development/scientific-guidelines/multidisciplinary-guidelines/multidisciplinary-biosimilar
Best regards,
Tomasz