|
KMID : 1142220130080010001
|
|
Regulatory Research on Food, Drug & Cosmetic
2013 Volume.8 No. 1 p.1 ~ p.12
|
|
|
|
|
Kang So-Young
Kim Seon-Hee
Baek Sun-Young
Eom Joon-Ho
Kim Young-Eun
Song Hyun
Baek Kyung-Min
Choi Young-Ju
Park Youn-Joo
Suh Soo-Kyung
Kang Shin-Jung
Oh Il-Ung
|
|
|
Abstract
|
|
|
|
The patent expiration of blockbuster originator biological products and the introduction of new approval pathways have accelerated the development of biosimilars. The number of biosimilars in the market is steadily growing. In Europe, 14 biosimilars have been approved for marketing, while in Japan 2 biosimilars have entered the market. In Korea, one biosimilar was approved in July 2012. In order to grant marketing authorization for biosimilars, a number of documents are required as much as new drug application. For this reason, we established a product-specific guidance, “Guidelines on similar medicinal products: non-clinical and clinical issues” to provide recommendations to be considered in the evaluation of biosimilar products for somatropin, erythropoietin, and GCSF. These guidelines describe how to evaluate the comparability of a biosimilar to a reference product through non-clinical studies including pharmacodynamics and toxicological studies, and clinical studies including pharmacokinetics, pharmacodynamics, and clinical efficacy studies. This guideline is expected to facilitate further development of biosimilars by providing detailed requirements for biosimilar approval.
|
|
|
KEYWORD
|
|
|
|
|
|
FullTexts / Linksout information
|
|
|
|
|
|
Listed journal information
|
|
|
|
|