Medical Writing Generics and biosimilars Writing biosimilar clinical study reports and submission documents – what to expect and what to consider
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Volume 28, Issue 2 - Generics and biosimilars

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

Abstract

With the emergence of biosimilars, the development process for these drugs is a topic of increasing interest to medical writers. Even though information and educational documents on the concept of biosimilarity are
increasingly publicly available, it takes some practice for the medical writer to translate the specific requirements into fit-for-purpose documents. This feature article summarises the relevant regulatory requirements for the clinical development of biosimilars. It includes best-practice recommendations on how these requirements can be translated into the everyday work for medical writers.

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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 Draft guidance; 2017.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.

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Articles

Introduction
James Visanji Tribute
President’s Message
EMWA News
Regulatory pathways for development and submission activities
Biosimilar development – an overview
Statistical principles in biosimilar development
Writing biosimilar clinical study reports and submission documents – what to expect and what to consider
Medical writing for generics throughout the life cycle
Same but different: Basic tools for biosimilar and generic pharmacovigilance writing
Layperson materials in the sphere of biosimilars and generic medicines
Insulin biosimilars
Biosimilars: Change, challenge, and accomplishments
ICMJE requirements for sharing individual participant data from interventional clinical trials
Medicinal products and medical devices in clinical trials conduct and disclosure
Publication of clinical trial protocols and statistical analysis plans on ClinicalTrials.gov
Collecting metrics in medical writing – the benefits to you and your business
Document management systems for medical writing
Winner of the Geoff Hall Scholarship Essay Competition
Regulatory Matters
News from the EMA
Getting Your Foot in the Door
Veterinary Medical Writing
Teaching Medical Writing
Medical Devices
My First Medical Writing
Journal Watch
Good Writing Practice
Regulatory Public Disclosure
Out on Our Own

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