Assessing biosimilarity and interchangeability of biosimilar products.

  title={Assessing biosimilarity and interchangeability of biosimilar products.},
  author={Shein-chung Chow},
  journal={Statistics in medicine},
  volume={32 3},
In the USA, for small molecule drug products, when an innovative (brand-name) drug product is going off patent, pharmaceutical and/or generic companies may file an abbreviated new drug application for approval of the generic copies of the brand-name drug. In 1984, the US Food and Drug Administration (FDA) was authorized to approve generic drug products under the Drug Price Competition and Patent Term Restoration Act, which is also known as the Hatch and Waxman Act. For approval of generic… CONTINUE READING
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