Special Report
Published in:
Volume 4 / Year 2015 / Issue 4
Volume 4 / Year 2015 / Issue 4
Patent expiry dates for best-selling biologicals
Author(s): GaBI Journal Editor
Page: 178-9
Page: 178-9
Abstract: 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… Read More »
Supporting biosimilarity and extrapolation
Author(s): GaBI Journal Editor
Page: 180-3
Page: 180-3
Abstract: 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… Read More »