Biosimilars: A consideration of the regulations in the United States and European union.

  • Justin R Daller
  • Published 2016 in Regulatory toxicology and pharmacology : RTP


Biosimilars are defined as biological products that are highly similar to a reference product, notwithstanding minor differences in clinically inactive components. Biosimilars show no clinically meaningful differences in safety, purity, and potency of the product in comparison to the reference product. With the ever looming patent expiry of some major high… (More)
DOI: 10.1016/j.yrtph.2015.12.013


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