Biosimilar
A biological product highly similar to an already approved reference biologic with no clinically meaningful differences in safety, purity, or potency. Follows abbreviated regulatory pathway (351(k) in US).
例
- Adalimumab biosimilars
- Trastuzumab biosimilars
- Interchangeable biosimilars
ご存知でしたか？
A biological product highly similar to an already approved reference biologic with no clinically meaningful differences in safety, purity, or potency. Follows abbreviated regulatory pathway (351(k) in US).