Stakeholders grapple with biosimilar issues at Japan meeting
This article was originally published in Scrip
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.
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Join us for a brief audio tour around the past week's major global biopharma industry developments, in this podcast version of Scrip's Five Must-Know Things.
Highlighting progress it has made over the past few years, Japan’s regulatory agency says it wants to raise even further the number of “Japan-first” approvals, as part of its stated mission to get safe and effective new drugs to patients more quickly.
Join us for a brief audio tour around the past week's key developments in the global biopharma industry, in this podcast version of Scrip's Five Must-Know Things.