Sandoz/Gan & Lee Now Has Applications for Glargine, Lispro and Aspart Insulin Biosimilars on File with FDA, Expect them to come to market in early 2024.

Five years ago, back on December 19, 2018, Swiss pharmaceutical giant Novartis Pharma AG quietly issued a press release (seehttps://www.globenewswire.com/news-release/2018/12/19/1669194/0/en/Sandoz-enters-into-commercialization-and-supply-agreement-for-insulin-biosimilars-anticipating-growing-demand-as-diabetes-burden-rises.html for the release itself) on behalf of the company ' s business unit known as Sandoz. Specifically, Novartis said that its Sandoz generics unit planned to introduce biosimilars, or near-copy, versions of Sanofi ' s Lantus (glargine), Novo Nordisk ' s Novolog (aspart), and Eli Lilly ' s Humalog (lispro). Sandoz intended to handle commercializing biosimilar, or near-copy, versions of those insulins around the world, while Gan& Lee would develop and manufacture them. The reason Sandoz cited in its press release for partnering with Gan& Lee was revealed:" Gan& Lee is a leading insulin supplier headquartered in China with more than 20 years ' experience in insulins and production capacity with attractive cost of goods sold (COGS) structures. "At the time, I presumed the reason Sandoz was opting for an offshore partner to manufacture insulin on its behalf (because Sandoz certainly could have done so itself) was so that Sandoz could pay multimillion dollar, legally-exempted rebate kickbacks to Pharmacy Benefit Manager ( " PBM " ) formulary managers. For example, we already have seen Biocon (initially via its co-development partner Viatris) was targ...
Source: Scott's Web Log - Category: Endocrinology Tags: 2023 Biosimilar biosimilars Gan & Lee insulin Sandoz Source Type: blogs