All the Guidance They Need: Biosimilars Business Development Doesn't Wait For FDA
This article was originally published in RPM Report
Wall Street is eagerly awaiting formal guidance from FDA on the new biosimilar pathway in the US. Biotech companies large and small aren't waiting.
You may also be interested in...
When it comes to the new biosimilar pathway, it’s the IND—not the BLA—that matters.
A joint venture with Korean conglomerate Samsung will be limited to making generic versions of non-Biogen products, although Samsung separately is working on a biosimilar of rituximab.
European experiences with "totality of the evidence" method also seem to be shaping policy, according to FDA article in NEJM.