A copy of a biologic drug that is highly similar but not identical, and needs its own clinical data to be approved.
生物类似药
| Move变动 | Where it appeared出现位置 | What it means这句话在说什么 |
|---|---|---|
| — | The patent cliff is coming for Merck's $31.7 billion drug 生物类似药 · 第 2 张术语卡 | Keytruda is a biologic, so its copies will be biosimilars rather than exact generics. 化学小分子药的仿制叫 generic，只要证明成分相同、生物等效即可；生物药由活细胞生产，做不到分子级完全一致，所以叫 biosimilar。美国给生物药 12 年数据保护期，欧洲是 10 年——这就是「专利到期」与「仿制品上市」之间常有一段时间差的原因。 |