Biosimilarity: resemble or not? The diffirence between biosimilarity and low molecule medicine
- Author:
Hoang Tich Huyen
- Publication Type:Journal Article
- Keywords:
Biosimilars
- MeSH:
Pharmaceutical Preparations, Medicine
- From:Journal of Medical Research
2005;39(6):107-109
- CountryViet Nam
- Language:Vietnamese
-
Abstract:
Studies of 11 biosimilarities. Result: in vitro bioactive was from 71-226% compared to Eprex. 9/11 biosilmilars had different isome from standard. Among 12 samples from 5 producers, the effectiveness was from 67.6% to 119.4% differently from European stardard. In three samples, toxic level was 15 higher than maximum accepted starndard. Isomeric samples also varied among producers. The study showed Epoetin produced outside of The United States and Europe had very different elements not in conformity with full process. The content on label was often lower or exceeded the limit.
