【BIO】Could the medicinal products from the same marketing authorization holder rather than the registered manufacturer be used as reference materials for developing biosimilar?

刊登日期:2019-11-11  |  點閱次數 : 464 次 

In order to accelerate the development of biosimilars and avoid repeated clinical trials due to different manufacturers, it is basically acceptable to use the products of other manufacturers of the original manufacturer (R') as the test control group. However, three pairwise comparability exercise among Biosimilar, the reference drug (R) approved in Taiwan, and the original manufacturer drug (R') purchased from other country should be performed. After the quality similarity between the three is established, R' can be used in comparative non-clinical or clinical trials for biosimilar development program.



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