Medical Writing Generics and biosimilars Layperson materials in the sphere of biosimilars and generic medicines
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Volume 28, Issue 2 - Generics and biosimilars

Layperson materials in the sphere of biosimilars and generic medicines

Abstract

Generics and biosimilars offer effective treatment alternatives to branded reference drugs at a lower cost. Despite their widespread use, patients have mis conceptions regarding their efficacy and safety. Layperson materials offer an important means by which patients can be educated in this regard. Here, we provide an overview of generics and biosimilars, describe how layperson materials fit into this landscape from a patientcentricity and regulatory perspective, and provide example language that can be used when developing layperson-orientated materials for generics and biosimilars.

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References

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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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