The way Lantus works is with higher order aggregates of insulin hexamers that unwind slower. The sequence is the important part.
I understand they may not be identical, my debate is whether it is practically the same, so similar that it is not even worth trying as a different medicine.
Do you have any idea which countries call it biosimilar? I value what the Danes say about insulin. But tracking down that stuff is hard enough when you are searching for your own country’s classification. What do the French say? The Swiss? The Germans? The Canadians? To me that would be interesting. I just wonder if the U.S. is on its own.
Think about Fiasp - available in Canada, available in the 28 European Union member states. But not here! They have filed for review here. Certainly it is because of the overwhelming process our FDA puts on that sort of thing that we have to wait.
