Volume 28, Issue 2 - Generics and biosimilars

Regulatory Matters

Author: Jennifer Clemens

References

1. U.S. Food & Drug Administration. Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations. Updated March 20, 2019 [cited 2019 Apr 03]. Available from: Available from: https://www.fda.gov/drugs/developmenta pprovalprocess/howdrugsaredevelopedand approved/approvalapplications/therapeutic biologicapplications/biosimilars/ ucm411418.htm
2. Diabetes UK. First use of insulin in treatment of diabetes on this day in 1922. Updated January 11, 2017 [cited 2019 Apr 03]. Available from: Available from: https://www.diabetes.org.uk/about_us/ news_landing_page/first-use-of-insulin-intreatment- of-diabetes-88-years-ago-today.
3. U.S. Food & Drug Administration. Biosimilars. Updated September 6, 2018 [cited 2019 Apr 03]. Available from: Available from: https://www.fda.gov/drugs/development approvalprocess/howdrugsaredevelopedand approved/approvalapplications/therapeutic biologicapplications/biosimilars/default.htm.
4. Troein P, Logendra R, Patel N. The impact of biosimilar competition in Europe. London, UK: QuintilesIMS™, May 2017 [cited 03 Apr 2019]. Available from: Available from: https://www.medicinesforeurope.com/ wp-content/uploads/2017/05/IMSBiosimilar- 2017_V9.pdf.
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