GENERICS AND BIOSIMILARS INITIATIVE JOURNAL
Official Journal of the Generics and Biosimilars Initiative
Volume 3 / Year 2014 / Issue 4
Opinion
Is Australia positioned to take advantage of biosimilars?
Author(s): David Lim, DPH
Page: 184-7Abstract: Australia currently has a small generic and biosimilar medicine industry despite having a good track record in biomedical research and a sound reputation in producing high quality but small volume biological pharmaceuticals. In recent times, Australia has made incremental changes to its regulation of biosimilars – in patent registration, in the use of commercial […]
Tell me the whole story: the role of product labelling in building user confidence in biosimilars in Europe
Author(s): European Biopharmaceutical Enterprises
Page: 188-92Abstract: The European Medicines Agency (EMA) has led the development of biosimilar regulatory pathways globally, tailoring their approach to meet the specific and scientifically determined needs of biosimilar development. However, the information-driven stepwise approach encouraged by this pathway leading to approval of biosimilar products is only reflected in a single section of the product labelling […]
