2018/2 GaBI Journal Table of Contents

Published in: Volume 7 / Year 2018 / Issue 2
Category: 2018/2 GaBI Journal Table of Contents
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Contents

Editor’s Letter

What to look forward to in GaBI Journal, 2018, Issue 2

Commentary

Potential changes to the FDA approach to biosimilars have a global impact

Original Research

Patient-reported outcome measures in phase III trials of LY2963016 insulin glargine and reference insulin glargine products: ELEMENT 1 and ELEMENT 2

Review Article

Protein heterogeneity and the immunogenicity of biotherapeutics

Perspective

How to realize the potential of off-patent biologicals and biosimilars in Europe? Guidance to policymakers

Regulatory

Regulation of copy biologicals in China

Biosimilar regulation and approval in Jordan

Meeting Report

Quality assessment of biosimilars in Colombia – reducing knowledge gaps

Opinion

Rationalizing FDA guidance on biosimilars—expediting approvals and acceptance

Abstracted Scientific Content

A call for coherence in EU legislation to promote generics

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