Medical Writing Generics and biosimilars Same but different: Basic tools for biosimilar and generic pharmacovigilance writing

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.

Download the full article

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.

Search

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

Links

The Write Stuff Archive Contact Instructions for Authors Article Template (Word) Journal Policies

Editoral Board

Editor-in-Chief

Raquel Billiones

Co-Editors

Evguenia Alechine

Jonathan Pitt

Managing Editor

Victoria White

Associate Editors

Anuradha Alahari

Jennifer Bell

Nicole Bezuidenhout

Claire Chang

Barbara Grossman

Sarah Milner

John Plant

Sampoorna Rappaz

Amy Whereat

Section Editors

Daniela Kamir

AI/Automation

Jennifer Bell

Biotechnology

Nicole Bezuidenhout 

Digital Communication

Somsuvro Basu

EMWA News 

Ana Sofia Correia 

Gained in Translation

Ivana Turek

Getting Your Foot in the Door

Wendy Kingdom / Amy Whereat

Good Writing Practice

Alison McIntosh 

In the Bookstores

Maria Kołtowska-Häggström

Lingua Franca and Beyond

Maddy Dyer

Publications

Lisa Chamberlain-James

Medical Communications/Writing for Patients

Payal Bhatia

Medical Devices

Evguenia Alechine

My First Medical Writing

Anuradha Alahari

News from the EMA

Adriana Rocha

Freelancing

Tiziana von Bruchhausen

Pharmacovigilance

Clare ChangZuo Yen Lee 

Regulatory Matters

Sam Hamilton

Regulatory Public Disclosure

Claire Gudex

Teaching Medical Writing

Louisa Ludwig-Begall / Sarah Kabani

The Crofter: Sustainable Communications

Louisa Marcombes

Veterinary Writing

Editors Emeritus

Elise Langdon-Neuner

Phil Leventhal

Layout Designer

Chris Monk