GENERICS AND BIOSIMILARS INITIATIVE JOURNAL
Official Journal of the Generics and Biosimilars Initiative
Volume 4 / Year 2015 / Issue 3
Review Article
Biosimilars patent litigation in the EU and the US: a comparative strategic overview
Author(s): Brian J Malkin, Esq
Page: 113-7Abstract: Biosimilars are highly similar versions of reference biological products, some with the potential to be deemed ‘interchangeable’ by regulatory bodies, such as the US Food and Drug Administration. Biosimilar patent litigation continues to evolve as biosimilars enter new global markets. This manuscript takes a look at patent litigation strategies in a more developed biosimilars […]
Biosimilars: extrapolation of clinical use to other indications
Author(s): David R Gaugh, RPh, Theresa L Gerrard, PhD, Gordon Johnston, RPh, MS
Page: 118-24Abstract: Biosimilars should be approved for all the clinical indications of the reference product based on the totality of the evidence even if there is no clinical safety and efficacy data for each indication. The foundation of biosimilar development is the demonstration that chemical, physical and biological parameters are highly similar to the reference product. […]
Generic pregabalin; current situation and implications for health authorities, generics and biosimilars manufacturers in the future
Author(s): Brian Godman, BSc, PhD, et al.
Page: 125-35Author byline as per print journal: Brian Godman, BSc, PhD; Michael Wilcock, MPharm; Andrew Martin, MPharm; Scott Bryson, MSc, MPH; Christoph Baumgärtel, MD; Tomasz Bochenek, MD, MPH, PhD; Winne de Bruyn, BSc; Ljiljana Sović Brkičić, MPharm; Marco D’Agata, MSc; Antra Fogele, PhD; Anna Coma Fusté, MSc; Jessica Fraeyman, PhD; Jurij Fürst, MD; Kristina Garuoliene, MD, PhD; Harald Herholz, MD, […]
