Volume 28, Issue 2 - Generics and biosimilars

Writing biosimilar clinical study reports and submission documents – what to expect and what to consider

Authors: Dr Katharina Brauburger, Sabrina Heisel-Stoehr

Abstract

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References

1. European Medicines Agency. Biosimilar medicines: marketing authorisation [cited 2019 Mar 01]. Available from: Available from: https://www.ema.europa.eu/en/humanregulatory/ marketing-authorisation/ biosimilar-medicines-marketingauthorisation.
2. Guideline on similar biological medicinal products: European Medicines Agency. Committee for Medicinal Products of Human Use (CHMP); CHMP/437/04 Rev 1.
3. ICH harmonized tripartite guideline. Structure and Content of Clinical Study Reports E3.
4. Structure and Content of Clinical Study Reports E3 Questions & Answers (R1): E3 Implementation Working Group
5. Clarity and Openness in Reporting: E3-based. Version 1.0, 03-May-2016.
6. TransCelerate Biopharma Inc. Common CSR Template [cited 2019 Mar 01]. Available from: Available from: https://www.transceleratebiopharmainc. com/assets/common-protocol-template/.
7. Radovan D. Biosimilar development – an overview. Med Writ. 2019;29(2):20–7.
8. Balfour A, Schmitt S. Statistical principles in biosimilar development. Med Writ. 2019;29(2):28–32.
9. Guidance for Industry: Considerations in Demonstrating Interchangeability With a Reference Product: U.S. Food and Drug Administration. Draft guidance; 2017.
10. European Medicines Agency. Multidisciplinary: biosimilar [cited 2019 Mar 01]. Available from: Available from: https://www.ema. europa.eu/en/humanregulatory/ research-development/ scientific-guidelines/multidisciplinary/ multidisciplinary-biosimilar.
11. US Food and Drug Administration. Biosimilars Guidances [cited 2019 Mar 01]. Available from: Available from: https://www.fda.gov/ BiologicsBloodVaccines/Guidance ComplianceRegulatoryInformation/ Guidances/General/ucm444891.htm? source=govdelivery&utm_medium=email &utm_source=govdelivery.
12. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: Quality issues, Revision 1 – Adopted guideline: European Medicines Agency. Committee for Medicinal Products of Human Use (CHMP); CHMP/BWP/247713/2012.
13. Sandoz, a Novartis division. Development of biosimilars [cited 2019 Mar 01]. Available from: Available from: https://www.sandoz. com/our-work/biopharmaceuticals/ development-biosimilars.