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February 01, 2015 (Vol. 35, No. 3)

How Similar Is Similar Enough?

New Tools Allow Comparison of Efficacy, Safety, and Quality of Follow-On Biologics or Biosimilars

  • Biosimilars are defined as drugs that are “highly similar” to or “interchangeable” with an approved biologic; for example Celltrion’s version of Remicade, Remsima. The lack of a clearly defined path to demonstrate such biosimilarity leaves the burden of proof on developers. Showing efficacy, quality, biopotency, and clinical safety often ...

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