Health Canada Ponders UK Model On Easing Biosimilar Study Requirements
US FDA Stand Unchanged For Now
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...
British Columbia Adds Insulins To Its Biosimilar Switching Policy
Patients taking Humalog and NovoRapid will have six months to switch to their biosimilar equivalents after British Columbia added the rapid-acting insulins to its biosimilar switching policy.
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 FDA Unlikely To Issue Broad Biosimilar Guidance Saying Comparative Clinical Studies Unnecessary
OTBB head Sarah Yim says FDA internal thinking is not aligned on the idea and that a lot of convincing was necessary to drop the clinical study requirement for insulin biosimilars.