Info On What It Costs To Make Insulin API ' s Offshore (Courtesy of China ' s Gan & Lee Pharmaceuticals Ltd.)

When pharma companies refer to API ' s, they are referring to " Active Pharmaceutical Ingredients " (which is different from what an internet company means when they say API; to internet companies, the acronym API means " Application Programming Interface " ). Regardless, pharma API ' s are commonly made offshore in places like India, Malaysia, China and elsewhere because its cheaper for them and therefore helps their own bottom lines. Its unclear to me exactly how they manage issues including transporting the products across the world for some items which must be temperature-controlled, but if it fattens pharma ' s bottom lines, they figure it out.Beijing, China-basedGan& Lee Pharmaceuticals Ltd., whichin 2018 signed a cooperation agreement with Sandoz to sell biosimilars of the three bestselling insulin analogues currently sold in the U.S. (specifically for glargine, aspart and lispro) has made news in 2023 largely due to the company ' s Sandoz agreement. (Incidentally, I believe Sandoz also intends to commercialize made by Gan& Lee of a GLP-1 receptor agonist FDA approved for the treatment of Type 2 diabetes [designated as GZR-1] which is a copy of the old Victoza formerly sold by Novo Nordisk.)Regardless, on February 23, 2023, Gan& Lee made news when the company disclosed it had become the first-ever China-based insulin manufacturer to formally file a Biologics License Application (BLA) with the U.S. Food and Drug Administration for an insulin biosimilar (spec...
Source: Scott's Web Log - Category: Endocrinology Tags: 2023 Biosimilar biosimilars BLA China COGS FDA Gan & Lee insulin Sandoz Source Type: blogs