專家有何貴幹

歐巴馬在3月20簽了biosimilar的法案

原來喬瑟夫是美國人

請問如何區分biosimilar products and interchangeable biosimilar

請幫我解惑......各位

走錯了

這個跟我們家沒有關係 請慢聊

那這個問題我要問誰阿?

小吉

請打諮詢專線 23224567分機888

我們有業績壓力. 請多利用

快打來啊快啊~

OK

下星期就打

Joseph320: 你問范范比較實在吧

FDA may waive these requirements, and others, in connection with its review of an application.

錯了，重來

Biosimilarity: FDA is authorized to approve biosimilar products based on, among other things:

analytic studies which show that the product is “highly similar” to an innovator or “reference product”

that was approved based on full clinical studies;animal toxicology studies; and one or more human studies that assess immunogenicity,

pharmacokinetics or pharmacodynamics. FDA may waive these requirements, and others, in connection with its review of an application.

Interchangeability: FDA may also approve a biosimilar product as “interchangeable” with the reference product.

To make this finding, FDA must first find that the product satisfies the biosimilarity requirements.

It must then determine that the biosimilar product is likely to produce the same clinical results as the reference product,

and that switching between the reference product and biosimilar does not result in diminished safety or efficacy.

昏了

寫的還蠻彈性的