Medical Writing Generics and biosimilars Biosimilar development – an overview
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Volume 28, Issue 2 - Generics and biosimilars

Biosimilar development – an overview

Abstract

Biosimilars are biological drugs that are similar to, and cheaper than other biological drugs (called “reference originator biologics”) that are already in use. They share an identical amino-acid sequence but, given the inherent variability of biological molecules, not full “sameness”. Biosimilar registration follows a strictly regulated pathway based on a totality-of-evidence approach. This article critically discusses the particulars of biosimilar development, including the continuous development of regulatory guidelines, familiarises readers with biosimilar-specific terminology, addresses the typical challenges of writing biosimilar dossiers, and summarises future directions in biosimilar development in the context of a changing competitive landscape. After reading this article, medical writers with different backgrounds, including those previously unfamiliar with key aspects of biosimilar development, should be able to better understand and apply these guidelines in their daily biosimilar work.

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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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