Introduction to the GaBI Journal
Journal Title: Generics and Biosimilars Initiative Journal - Year 2012, Vol 1, Issue 1
Abstract
I am proud and pleased to be able to write the introduction to this first issue of the Generics and Biosimilars Initiative Journal (GaBI Journal).
Authors and Affiliations
Philip D Walson
Rhythm
Clinical biosimilar data should be accessible to all Calls are growing for biosimilar manufacturers to publish their data in the public domain, particularly when developing versions of monoclonal antibodies that are asso...
Pharmacovigilance of biosimilars: challenges and possible solutions
Post-marketing surveillance is essential to detect, assess and prevent adverse reactions of chemically synthesized small molecule drugs as well as biologicals, as the full safety profile can only be known after they have...
The authorization of non-biological complex drugs (NBCDs) follow-on versions: specific regulatory and interchangeability rules ahead?
Introduction: Besides biologicals, a new class of complex drugs – non-biological complex drugs (NBCDs), e.g. liposomes, iron carbohydrate products and glatiramoids – has emerged. Originator NBCD products have been approv...
Introduction to the GaBI Journal
I am proud and pleased to be able to write the introduction to this first issue of the Generics and Biosimilars Initiative Journal (GaBI Journal).
New EU guidance for the evaluation of medicinal products with modified drug release will be finished by the middle of 2014
The guideline ‘Note for guidance on modified release oral and transdermal dosage forms: Section II (Pharmacokinetic and clinical evaluation)’ [1] was issued over 10 years ago, and the need for revision was recognized in...