A new draft guidance from the U.S. FDA has opened the door for the development of insulin biosimilars, potentially allowing for cheaper near-identical versions of these biologic drugs to be interchanged with the originator. This is bad news for companies like Sanofi and Novo Nordisk, who are already under pressure to cut prices of their branded insulins in the US amid wider scrutiny about prescription drug prices. It also brings the US in line with the European Medicines Agency, which introduced a biosimilar approval pathway first and has already approved biosimilar insulins. Learn More