Assessing biosimilarity and interchangeability of biosimilar products.

@article{Chow2013AssessingBA,
  title={Assessing biosimilarity and interchangeability of biosimilar products.},
  author={Shein-chung Chow},
  journal={Statistics in medicine},
  year={2013},
  volume={32 3},
  pages={
          361-3
        }
}
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
Related Discussions
This paper has been referenced on Twitter 2 times. VIEW TWEETS

Citations

Publications citing this paper.
Showing 1-9 of 9 extracted citations

Biosimilars: where we were and where we are.

Journal of biopharmaceutical statistics • 2014
View 8 Excerpts
Method Support
Highly Influenced

ow to Compare Biologic Drugs

avier Calvet, Juan Vicente Espluguesb
2017

Switching to biosimilar infliximab (CT-P13): Evidence of clinical safety, effectiveness and impact on public health.

Biologicals : journal of the International Association of Biological Standardization • 2016
View 2 Excerpts

References

Publications referenced by this paper.
Showing 1-7 of 7 references

Quantitative evaluation of bioequivalence/biosimilarity

SC Chow
Journal of Bioequivalence and Bioavailability • 2011
View 2 Excerpts

Statistical assessment of biosimilar products.

Journal of biopharmaceutical statistics • 2010
View 1 Excerpt

Design and Analysis of Bioavailability and Bioequivalence Studies—Revised and Expanded

SC Chow, JP Liu
Third edn. Taylor & Francis: • 2008
View 2 Excerpts

Generics and Biosimilars Initiative

SC Chow, JP Liu
-1