Stakeholders grapple with biosimilar issues at Japan meeting
This article was originally published in Scrip
Executive Summary
When is "similar" similar enough? This was the core question representatives of industry and regulators got to grips with at an international symposium on biosimilars in Tokyo. Debate over comparability and divergent views on the effect of small product variations on safety and efficacy threw into relief the still emerging regulatory science in this field.
You may also be interested in...
Quick Listen: Scrip’s Five Must-Know Things
Join us for an audio catch-up on the latest key developments in the global biopharma industry, as reported by Scrip's global team, in this mini podcast version of Five Must-Know Things.
Japan Regulators Kept On Track Despite Pandemic
While it was not as affected as some other countries, Japan still had the pandemic to deal with and regulators responded while managing to keep up regular product review work, including several world-first approvals. Coronavirus vaccine roll-outs and the first general annual reimbursement price cut are on the cards for this year.
Quick Listen: Scrip’s Five Must-Know Things
Join us for an audio catch-up on the latest key developments in the global biopharma industry, as reported by Scrip's global team, in this mini podcast version of Five Must-Know Things.
Need a specific report? 1000+ reports available
Buy Reports