Medical Writing Generics and biosimilars Biosimilars: Change, challenge, and accomplishments

Volume 28, Issue 2 - Generics and biosimilars

Biosimilars: Change, challenge, and accomplishments


Since the first biosimilar product was approved in Europe in 2006, there have been many developments in the global regulatory environment, and the healthcare community’s understanding and acceptance of biosimilars. However, there are still a number of challenges in developing, registering, and marketing biosimilar medicines, with the ultimate objective always being to increase competition, drive down costs, and increase access to biologic medicines. This article examines progress to date in the establishment of the biosimilar market, challenges in bringing biosimilars to patients, the impact biosimilars have had, and potential future trends.

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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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Lingua Franca and Beyond

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Medical Devices

Evguenia Alechine

My First Medical Writing

Anuradha Alahari

News from the EMA

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Regulatory Matters

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Regulatory Public Disclosure

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