Medical Writing Generics and biosimilars Regulatory Matters

Volume 28, Issue 2 - Generics and biosimilars

Regulatory Matters


  1. U.S. Food & Drug Administration. Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations. Updated March 20, 2019 [cited 2019 Apr 03]. Available from: Available from: pprovalprocess/howdrugsaredevelopedand approved/approvalapplications/therapeutic biologicapplications/biosimilars/ ucm411418.htm
  2. Diabetes UK. First use of insulin in treatment of diabetes on this day in 1922. Updated January 11, 2017 [cited 2019 Apr 03]. Available from: Available from: news_landing_page/first-use-of-insulin-intreatment- of-diabetes-88-years-ago-today.
  3. U.S. Food & Drug Administration. Biosimilars. Updated September 6, 2018 [cited 2019 Apr 03]. Available from: Available from: approvalprocess/howdrugsaredevelopedand approved/approvalapplications/therapeutic biologicapplications/biosimilars/default.htm.
  4. Troein P, Logendra R, Patel N. The impact of biosimilar competition in Europe. London, UK: QuintilesIMS™, May 2017 [cited 03 Apr 2019]. Available from: Available from: wp-content/uploads/2017/05/IMSBiosimilar- 2017_V9.pdf.
  5. Riedel S. Edward Jenner and the history of smallpox and vaccination. Proc (Bayl Univ Med Cent). 2005;18(1):21–5. Available from: Available from: pmc/articles/PMC1200696/.



James Visanji Tribute
President’s Message
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
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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Editoral Board


Raquel Billiones


Evguenia Alechine

Jonathan Pitt

Managing Editor

Victoria White

Deputy Managing Editor

Alicia Waltman

Associate Editors

Anuradha Alahari

Jennifer Bell

Clare Chang

Barbara Grossman

Daniela Nakagawa

Joselita T. Salita

Petal Smart

Amy Whereat

Section Editors

Nicole Bezuidenhout 

Digital Communication

Somsuvro Basu

EMWA News       

Aurélie Gobet / Paolo Rega

Gained in Translation

Ivana Turek

Getting Your Foot in the Door

Wendy Kingdom / Amy Whereat

Good Writing Practice

Alison McIntosh / Stephen Gilliver

In the Bookstores

Maria Kołtowska-Häggström

Lingua Franca and Beyond

Phil Leventhal

Manuscript Writing

Lisa Chamberlain-James

Medical Communications/Writing for Patients

Namrata Upadhyay

Medical Devices

Evguenia Alechine

My First Medical Writing

Anuradha Alahari

News from the EMA

Laura Kehoe

Out on Our Own

Tiziana von Bruchhausen


Jennifer Morris

Regulatory Matters

Sam Hamilton

Regulatory Public Disclosure

Claire Gudex

Teaching Medical Writing

Kimi Uegaki

The Crofter: Sustainable Communications

Jennifer Bell / Louisa Marcombes

Veterinary Writing

Editors Emeritus

Elise Langdon-Neuner

Phil Leventhal

Lay out Designer

Chris Monk