I'ld like to know how much similarity a molecule should show with innovator molecule in order to consider it as a Biosimilar ?
Hello Vikram Kumar
A biosimilar is a biological product that is approved based on the totality of evidence demonstrating that it is highly similar to an approved biological product (originator) in terms of structure, function, quality, and clinical efficacy and safety.
It is not possible to generate a molecule which is the same or identical copy of an innovator product. So, biosimilars are considered “similar but not the same” to the original biologic innovator product.
The analytical tests currently available are not sophisticated enough to detect the slight but important structural differences between innovator and biosimilar products. Modest differences may have clinical implications and pose a significant risk to patient safety.
Therefore, it is considered necessary that biosimilars must be assessed for clinical efficacy and safety by valid preclinical and clinical studies before marketing approval. The innovator products and biosimilars are not interchangeable. Therefore, it is essential to monitor patients if their treatment is changed between products.
Hope this helps.
Best.
Dear Vikram, the molecule structure comparison is not the main criteria to define a biosimilar. If you want to know more about health policy aspects of biosimilars, please read this study. The switch between originators and biosimilars have pros and cons ...
Article Patient Access, Unmet Medical Need, Expected Benefits, and C...
Hi Vikram Kumar,
As noted, biosimilarity is determined using a totality of evidence approach focused on a stepwise consideration of structural similarity and functional equivalence.
Biosimilars are also required to show an absence of clinically significant differences to the reference product.
This means there is no simple percentage difference that can be regarded as acceptable.
I hope that helps.
All the best.
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