Last Updated on May 7, 2025 by The Health Master
Vedolizumab
Central Drug Standard Control Organization approval (CDSCO approval) has been granted to Intas Pharmaceuticals to initiate a Phase I clinical trial for its Vedolizumab biosimilar.
This CDSCO approval is granted on the recommendation of the Subject Expert Committee (SEC).
The Clinical Trial
The proposed Phase I clinical trial of Vedolizumab biosimilar (INTP 53) is a specially designed study to assess the bioequivalence of the product with Entyvio, the reference product that was manufactured by Takeda Pharmaceuticals.
What is Vedolizumab?
Vedolizumab is a monoclonal antibody with cutting-edge humanization specifically designed to target and block the α4β7 integrin.
This interaction is very important for the migration of immune cells to sites of inflammation in the gut.
By prohibiting this process, Vedolizumab offers a therapeutic approach for inflammatory bowel diseases (IBDs) e.g. Crohn’s disease and ulcerative colitis.
Mechanism of Action
- Vedolizumab exhibits highly selective targeting, binding exclusively to the α4β7 integrin.
- Vedolizumab does not interfere with the function of other integrins, e.g., α4β1 and αEβ7, which are very important for vital bodily functions.
- Vedolizumab selectivity minimizes the risk of systemic side effects that are associated with other immunosuppressive therapies.
SEC Recommendation
SEC has thoroughly reviewed all the clinical trial protocol of Vedolizumab during the meeting on January 21, 2025, held for gastroenterology and hepatology, and unanimously recommended approval for the initiation of the Phase I clinical trial of the aid product.
Q. What is Vedolizumab ?
Vedolizumab is a monoclonal antibody with cutting-edge humanization specifically designed to target and block the α4β7 integrin.
Q. What is a biosimilar ?
A biosimilar is a product that is highly similar to an biological product whic is alreday approved.
Q. Why is the development of a Vedolizumab biosimilar important ?
Biosimilars can be very useful in providing more affordable treatment options for patients with IBDs, increasing access to this vital medication.
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