Canada's biosimilars market moves up a gear
This article was originally published in SRA
Executive Summary
There has been little action to date in the “subsequent entry biologics” field in Canada, with few submissions being filed and even fewer biologics patents being challenged. With the filing of the first SEB patent case, however, things are getting interesting, says Paula Bremner.
You may also be interested in...
CDER, CBER Not Seeing Hiring Slowdown Despite US FDA Warnings
FDA officials have said hiring could be slowed if an inflationary pay increase is not included in the agency budget, but CDER and CBER continue to add staff at a steady pace.
Medicare Reimbursement For Part B Drugs Is 48% Above 340B Prices To Hospitals, MedPAC Finds
New study updates past commission analyses and highlights the significant margin between Medicare payments for drugs and the prices paid by 340B-eligible providers.
Drug Shortages, Inspections In Focus At US FDA Appropriations Hearing
Commissioner Robert Califf discussed the agency’s request for $12.3m to address shortages and legislation to require that manufacturers provide more detailed information about increased demand and supply chain vulnerabilities.