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).
Beispiele
- Adalimumab biosimilars
- Trastuzumab biosimilars
- Interchangeable biosimilars
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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).