Medical Writing Generics and biosimilars Medical writing for generics throughout the life cycle

Volume 28, Issue 2 - Generics and biosimilars

Medical writing for generics throughout the life cycle


Medical writing plays an integral part in the pharmaceutical industry, be it for originator or generic drug companies. Most writers are working for medium to large research-based companies. However, even for generic drug firms many documents need to be composed, preferably by or with the help of a medical writer. This article aims to familiarise the reader with the usual terminology and relevant guidelines. Key documents throughout the entire life cycle of generic medicinal products are described, starting with the clinical documents during the development process, continuing with required support for the authorisation process, and concluding with post-marketing material.

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  1. European Medicines Agency. Generic and hybrid medicines. [cited 2019 Mar 07] Available from: Available from: https://www.ema.europa. eu/en/human-regulatory/marketingauthorisation/ generic-hybrid-medicines.
  2. Fusier I, Tollier C, Husson MC. Medicines containing pharmaceutical excipients with known effects: a French review. Pharm World Sci. 2003;25(4):152 5.
  3. Rowe RC, Sheskey PJ, Weller PJ. (2003). Handbook of pharmaceutical excipients. London: Pharmaceutical Press.
  4. Annex to the European Commission guideline on ‘Excipients in the labelling and package leaflet of medicinal products for human use’ (SANTE-2017-11668). EMA/CHMP/302620/2017 Corr. 1. European Medicines Agency; 2018 Nov 19 [cited 2019 Mar 09]. Available from: Available from: commission-guidelineexcipients- labelling-package-leafletmedicinal- products-human.
  5. Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community Code Relating to Medicinal Products for Human Use. Official Journal L- 311,28/11/2004, p. 67-128. [cited 2019 Feb 08]. Available from: Available from: https://eurlex. ?uri= CELEX%3A32001L0083.
  6. Guideline on the Investigation of Bioequivalence. CPMP/EWP/QWP/ 1401/98 Rev. 1/ Corr. European Medicines Agency; 2010 Jan 20 [cited 2019 Mar 06]. Available from: Available from: https://www.ema.europa. eu/en/investigation-bioequivalence.
  7. van der Meersch A, Dechartres A, Ravaud P. Quality of reporting of bioequivalence trials comparing generic to brand name drugs: a methodological systematic review. PLoS One. 2011;6(8):e23611.
  8. Al Ameri MN, Nayuni N, Anil Kumar KG, Perrett D, Tucker A, Johnston A. The differences between the branded and generic medicines using solid dosage forms: In-vitro dissolution testing. Results Pharma Sci. 2011;2:1 8.
  9. Davit BM, Kanfer I, Tsang YC, Cardot JM. Götsch-Schmidt –Medical writing for generics throughout the life cycle Medical writing for generics poses its own challenges and requires some specialist knowledge. 44 | June 2019 Medical Writing | Volume 28 Number 2 Medical writing for generics throughout the life cycle – Götsch-Schmidt BCS Biowaivers: Similarities and Differences Among EMA, FDA, and WHO Requirements. AAPS J. 2016;18(3):612 8
  10. ICH guideline M9 on biopharmaceutics classification system based biowaivers, step 2b. EMA/CHMP/ICH/493213/2018. European Medicines Agency; 2018 Aug 06. [cited 2019 Mar 07]. Available from: Available from: biopharmaceutics-classification-systembased- biowaivers
  11. Stuart MC. The Complete Guide to Medical Writing. London: Pharmaceutical Press; 2007.
  12. Generics and Biosimilars Initiative. EU guidelines for generics Posted 08/10/2010. Last update: 18 November 2011. [cited 2019 Mar 07]. Available at: Available from: EU-guidelines-for-generics
  13. EudraLex Notice to Applicants Volume 2B - Presentation and content of the dossier. Edition May 2008 [cited 2019 Mar 07]. Available from: Available from: health/documents/ eudralex/vol-2_de.
  14. QRD general principles regarding the SmPC information for a generic/hybrid/biosimilar product. EMA/627621/2011 rev.1. European Medicines Agency; 2018 Jun 18. [cited 2019 Mar 07]. Available from: Available from: human-regulatory/marketingauthorisation/ product-information/ product-information-reference-documentsguidelines.
  15. Guideline on good pharmacovigilance practices (GVP), Module V – Risk management systems (Rev 2). EMA/838713/2017 Rev 2. European Medicines Agency; 2017 Mar 28 [cited 2019 Mar 06]. Available from: Available from: post-authorisation/ pharmacovigilance/goodpharmacovigilance- practices#final-gvpmodules- section.
  16. Appendix IV of the Guideline on the Investigation on Bioequivalence (CPMP/EWP/QWP/1401/98 Rev.1): Presentation of Biopharmaceutical and Bioanalytical Data in Module 2.7.1. EMA/CHMP/600958/2010/Corr.* Committee of Medicines for Human Use (CHMP); 17 November 2011. [cited 2019 Mar 08]. Available from: Available from: guideline-investigation-bioequivalencepresentation- biopharmaceutical-bio analytical-data.
  17. Directive 2010/84/EU of the European Union Parliament and of the Council of 15 December 2010 amending, as regards to pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use. [cited 2019 Feb 08]. Available from: Available from: https:// TXT/?qid=1549629653590&uri=CELEX: 32010L0084.
  18. Guideline on good pharmacovigilance practices (GVP), Module VII – Periodic safety update report (Rev 1). EMA/816292/2011 Rev 1. European Medicines Agency; 2013 Dec 09 [cited 2019 Mar 06]. Available from: Available from: https://www.ema.europa. eu/en/humanregulatory/ post-authorisation/ pharmacovigilance/goodpharmacovigilance- practices#final-gvpmodules- section
  19. CMDh Best Practice Guide on the processing of renewals in the Mutual Recognition and Decentralised Procedures. CMDh/004/2005/Rev.16. February 2018 [cited 2019 Mar 08]. Available from: Available from:
  20. Bundesamt für Sicherheit im Gesundheitswesen (Austrian Federal Office for Safety in Health Care). FAQs about Pharmacovigilance, question 1.2 PHV documents for renewal procedure. [cited 2019 Mar 08]. Available from: Available from: ance/faqs-about-pharmacovigilance/.



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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
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Journal Watch
Good Writing Practice
Regulatory Public Disclosure
Out on Our Own


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