Health Canada Ponders UK Model On Easing Biosimilar Study Requirements
US FDA Stand Unchanged For Now
Executive Summary
Discussions are ongoing at Health Canada on the feasibility of adopting the UK model of easing clinical study requirements for biosimilars, said director general Celia Lourenco at a recent event. Meanwhile, the US FDA’s stance is unchanged for now.
You may also be interested in...
Biosimilars Canada Boss Calls For Ontario Switching Policy
Biosimilars Canada president Jim Keon has urged the province of Ontario to follow other Canadian provinces by adopting a biosimilar switching policy for its public drug program, in order to cut costs on biologics and re-invest in the healthcare system.
US ‘Lags Behind’ EU & Canada On Clinical Data Transparency
The US Food and Drug Administration has proactively released data for just one drug, compared with data released for over 100 drugs by the European Medicines Agency and just over 70 drugs by Health Canada, according to a study that compared the accessibility and comprehensiveness of the data that the three regulators proactively or reactively disclose.
US FDA’s PANDA Policy Could Pose Legal Problems For Biosimilars, Attorney Says
Agency’s apparent ‘intellectual exercise’ in treating pre-Hatch-Waxman ANDAs as NDAs could expose biosimilars to liability, Teva deputy general counsel notes at FDLI conference.