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Biosimilar

Research

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).

उदाहरण

  • Adalimumab biosimilars
  • Trastuzumab biosimilars
  • Interchangeable biosimilars

क्या आप जानते हैं?

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).