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By Bill Galluccio Photo: Getty Images The U.S. Food and Drug Administration announced that it has approved the first interchangeable biosimilar insulin product. The approval will allow pharmacists to automatically swap out expensive, brand-name insulin with the cheaper generic version. The FDA said that the biosimilar drug Semglee is interchangeable with Lantus, a widely prescribed insulin analog. Before the FDA approved Semglee, a doctor had to specifically prescribe a generic brand of insulin or approve the substitution. Now, the name-brand drug can be swapped out by a pharmacist without ...

Semglee Approved as First Interchangeable Biosimilar Insulin Product Credit: Biocon Biologics The Food and Drug Administration (FDA) has approved Semglee ® (insulin glargine-yfgn injection) as the first interchangeable biosimilar insulin product indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. Semglee is a long-acting human insulin analogue that has an identical amino acid sequence to Lantus ® (insulin glargine). The interchangeable biosimilar product may now be substituted for the re...

First interchangeable biosimilar insulin product approved by FDA for treatment of diabetes Today, the U.S. Food and Drug Administration approved the first interchangeable biosimilar insulin product, indicated to improve glycemic control in adults and pediatric patients with Type 1 diabetes mellitus and in adults with Type 2 diabetes mellitus. Semglee (insulin glargine-yfgn) is both biosimilar to, and interchangeable with (can be substituted for), its reference product Lantus (insulin glargine), a long-acting insulin analog. Semglee (insulin glargine-yfgn) is the first interchangeable biosimil...

The controversial approval of an Alzheimer’s drug reignites the battle over the underlying cause of the disease Laurie McGinley © Jessica Rinaldi/Pool/Via Reuters Marc Archambault, who has early-stage Alzheimer's disease, receives his first dose Wednesday of the newly approved intravenous drug Aduhelm at Butler Hospital in Providence, R.I. (Jessica Rinaldi/Pool/Reuters) Neurologist Matthew S. Schrag was surprised when he heard the Food and Drug Administration had approved a controversial Alzheimer’s drug. There was scant evidence the treatment worked, in his view. ...

US lawmakers launch investigation into the controversial FDA approval of the first Alzheimer's drug since 2003 and why it costs $56,000 The House Committee on Oversight and Reform and the House Committee on Energy and Commerce launch investigation into the controversial approval of Aduhelm The drug received approval despite mixed clinical trials results, though it did show it could potentially reduce cognitive decline by 22% Lawmakers are concerned about the drug's steep price tag, that will cost $56,000 per year of treatment  The FDA has defended its decision to approve Aduhelm, saying it i...