GENERICS AND BIOSIMILARS INITIATIVE JOURNAL
Official Journal of the Generics and Biosimilars Initiative
Volume 4 / Year 2015 / Issue 4
Special Report
Supporting biosimilarity and extrapolation
Author(s): GaBI Journal Editor
Page: 180-3Abstract: With many biosimilars being approved around the world, there is an urgent need for clear guidelines on establishing biosimilarity and on approving subsequent extrapolation. The balance between clinical studies and analytics in establishing and confirming biosimilarity are discussed in this paper. Submitted: 28 July 2015; Revised: 15 August 2015; Accepted: 16 August 2015; Published […]
Patent expiry dates for best-selling biologicals
Author(s): GaBI Journal Editor
Page: 178-9Abstract: Biosimilars have been approved in Europe since 2006. With patents on originator biologicals expiring and ever-tightening healthcare budgets biosimilars are likely to take an increasing share of the biologicals market. In light of these facts, this article gives estimated patent expiry dates for just some of the best-selling biologicals. Submitted: 19 November 2015; Revised: […]
