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May 15, 2018 (Vol. 38, No. 10)

Managing Biosimilars Is Like Herding Copycats

Developers and Regulators Are Attending to Naming Conventions and Equivalence Testing Assays

  • Biosimilars, or copycats of biologic drugs, stray from clearly defined categories. Each biosimilar comes from a unique biomanufacturing environment and, consequently, possesses unique chemical attributes, which may or may not prove to be clinically relevant—most likely not (but worth checking). Moreover, each biosimilar may go its own way, ...

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