Another “Biosimilar” Milestone: FDA Tentatively Approves Lilly/BI Copy Of Lantus
This article was originally published in RPM Report
It isn’t a 351K pathway drug, but it does set up an interesting comparison for sponsors using the formal biosimilar pathway compared to the 505(b)(2) NDA route.
You may also be interested in...
The debate over an abbreviated biologics pathway took a big step forward with the Food & Drug Administration's approval of Sandoz' recombinant human growth hormone Omnitrope. The approval itself is precedent setting, but the bigger ramifications are political: the action steps up the pressure on Congress to address the issue head-on.
FDA's guidance on biogenerics is on the backburner: Congress is showing little interest in pushing the agency towards them. But some follow-on products are already making it to the market.
FDA is hoping Congress might take up proposed legislation governing the regulation of diagnostic tests produced in laboratories in 2023. That will make it a full decade of stalemate since FDA outlined a framework to address the new reality of personalized medicine.