What is The Role of Comparative Clinical Studies in the Development of Oncology Bio-similars?

Bio-similars are products with the potential to provide wider access to biologics and cut down the costs of cancer care.

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.

prognosis3 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

#Healthcare, #ClinicalDataManagement, #ObservationalStudy

Article Source: http://bit.ly/386CAQG
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