Medical Writing Generics and biosimilars Same but different: Basic tools for biosimilar and generic pharmacovigilance writing
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Volume 28, Issue 2 - Generics and biosimilars

Same but different: Basic tools for biosimilar and generic pharmacovigilance writing

Abstract

Biosimilars are medicinal products, which are highly similar to an already authorised biological product; generics are identical copies of an already authorised chemical entity. As for any other medicinal product,
biosimilars and generics require the writing of pharmacovigilance documents, such as DSURs, RMPs, and PSURs, for submission to health agencies. Due to the nature of biosimilars and generics, the medical writer
needs to take into account some specifics while preparing pharmacovigilance documents.

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References

  1. Guideline on Similar Biological Medicinal Products. European Medicines Agency and Committee for Medicinal Products for Human Use (CHMP).23 Oct 2014 [cited 21 Jan 2019]. Available from: Available from: https://www.ema.europa.eu/documents/ scientific-guideline/guideline-similarbiological- medicinal-products-rev1_en.pdf.
  2. Sydow S, Grajer KH. Biosimilars: Die Sicht der Innovatoren. Pharm. Unserer Zeit. 6/2012 (41)
  3. Guideline on Good Pharmacovigilance Practices (GVP) – Annex I (Rev 4). European Medicines Agency and Heads of Medicines Agencies. 09 Oct 2017 [cited 05 Feb 2019]. Available from: Available from: https://www.ema.europa.eu/documents/ scientific-guideline/guideline-goodpharmacovigilance- practices-annex-idefinitions- rev-4_en.pdf .
  4. EMA homepage. European Medicines Agency. [cited 05 Feb 2019]. Available from: Available from: https://www.ema.europa.eu/en/ human-regulatory/marketingauthorisation/ biosimilar-medicinesmarketing- authorisation
  5. GaBI homepage. Generics and Biosimilars Initiative. [cited 05 Feb 2019]. Available from: Available from: http://gabionline.net/ Generics/ General/WHO-definitions-of-generics.
  6. International conference on harmonisation of technical Requirements for registration of pharmaceuticals for human use – ICH Harmonised Tripartite Guideline – Development Safety Update Report E2F. Current Step 4 version, dated 17 August 2010. Available from: https://www.ich.org/fileadmin/ Public_Web_Site/ICH_Products/ Guidelines/Efficacy/E2F/Step4/E2F_ Step_4.pdf.
  7. Guideline on Good Pharmacovigilance Practices (GVP) Module V – Risk manage - ment systems (Rev 2). European Medicines Agency and Heads of Medicines Agencies; 28 Mar 2017 [cited 19 Feb 2019]. Available from: Available from: https://www.ema. europa.eu/ documents/ scientific-guideline/guidelinegood- pharmacovigilance-practices-modulev- risk-management-systems-rev-2_en.pdf.
  8. Guideline on Good Pharmacovigilance Practices (GVP) - Product- or Population- Specific Considerations II: Biological medicinal products. European Medicines Agency and Heads of Medicines Agencies; 04 Aug 2016 [cited 17 Jan 2019]. Available from: Available from: https://www.ema.europa.eu/ documents/scientific-guideline/guidelinegood- pharmacovigilance-practices-gvpproduct- population-specific-considerations -ii_en-0.pdf.
  9. Guideline on Good Pharmacovigilance Practices (GVP) Module VII – Periodic safety update report (Rev 1). European Medicines Agency and Heads of Medicines Agencies; 09 Dec 2018 [cited 17 Jan 2019]. Available from: Available from: https://www.ema.europa. eu/documents/scientific-guideline/ guideline-good-pharmacovigilancepractices- gvp-module-vii-periodic-safetyupdate- report_en.pdf.
  10. ICH guideline E2C (R2) on periodic benefit-risk evaluation report (PBRER). European Medicines Agency. January 2013 [cited 22 Jan 2019]. Available from: Available from: https://www.ema.europa.eu/documents/ regulatory-procedural-guideline/ international-conference-harmonisationtechnical- requirements-registrationpharmaceuticals- human-use_en-0.pdf.
  11. Explanatory Note to GVP Module VII. European Medicines Agency and Human Medicines Evaluation Division; 31 Oct 2017 [cited 22 Jan 2019]. Available from: Available from: https://www.ema.europa.eu/documents/ scientific-guideline/guideline-goodpharmacovigilance- practices-gvp-modulevii- periodic-safety-update-reportexplanatory_ en.pdf.

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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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