To make this happen, it is important for oncologists to appreciate the differences between the comparative clinical studies and the conventional phase III studies.
In bio-similar development, a comparative study compares the clinical equivalence between a bio-similar and its reference product on the basis of pre-specified margins.
The study aims at understanding the role of comparative clinical studies in reference to oncologic bio-similars using studies performed on trastuzumab bio-similars.
The study used a relevant study population and specific efficacy endpoints that were sensitive enough to detect the differences between various products.
If the comparative studies are successful at demonstrating bio-similarity, no additional clinical trials will be needed for further approval.
While some experts argue that comparative studies are unnecessary, they can greatly revolutionize the treatment outcomes in cancer care.
3 Key Points
1. Bio-similars are clinically equal to their reference products and possess a great potential to improve the health care systems.
2. The trials conducted on trastuzumab bio-similars prove that comparative studies for clinical efficacy and safety are different from the conventional Phase III studies.
3. The distinct confirmatory role of comparative studies using a sensitive population and appropriate endpoints must be promoted and appreciated by the clinicians.
“For bio-similars, the positive benefit-risk profile is based on the totality of the evidence that demonstrates bio-similarity to the reference product rather than on efficacy and safety studies in each approved indication.”- Dr. Justin Stebbing
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