FDA Approves New Insulin Glargine Basaglar – The First “Biosimilar” Insulin in the US

Twitter Summary: 1^st ever “biosimilar” insulin approved in US – potential to come cheaper than other insulins, with launch in December 2016

Lilly/BI recently announced the FDA approval of its long-awaited biosimilar insulin glargine, Basaglar, for type 1 and type 2 diabetes. Basaglar is biologically similar to Sanofi’s basal insulin Lantus (insulin glargine), including the same protein sequence and a similar glucose-lowering effect. While the FDA does not call it a “biosimilar” drug for regulatory reasons, it can essentially be thought of as an alternative form of Lantus. Pricing for Basaglar is unknown at this time (more on this below), and the drug will not be launching in the US until after December 15, 2016.

Why are “biosimilar” insulin options exciting? Most notably, they could potentially be offered at lower costs than brand name insulins. Basaglar has already launched in several international countries (under the brand name Abasaglar) and is typically priced at a 15%-20% discount relative to Lantus in those markets. It’s not clear yet how the discounts for Basaglar will compare in the US, and how much less patients with insurance might pay.

“Generic” versions of drugs in the US typically come at a 50-80% discount to the original product. But unlike most generic drugs, biosimilar insulins are much more expensive to manufacture, so it’s unlikely they’ll see that same level of discount in the US. Indeed, Novartis launched the first “biosimilar” drug approved in the US last September (not in diabetes), which came at a 15% discount.

Still, we’ve heard great optimism that biosimilar insulin glargine will help patients facing higher insulin costs. At the IDF conference in December, Dr. Matthew Riddle suggested that of all the insulins newly coming to the market, Basaglar will help the greatest number of people with its presumably lower price. In fact, he estimated that 50% of all people with type 2 diabetes would benefit from biosimilar insulin glargine, compared to just 25% of patients benefiting from the reduced hypoglycemia and flatter glucose profile seen with next-generation brand name basal insulin analogs such as Novo Nordisk’s Tresiba and Sanofi’s Toujeo. Even small discounts for Basaglar compared with Lantus may benefit those with financial barriers to insulin, particularly those who are uninsured or underinsured.

This approval comes as no surprise, as the FDA had tentatively approved Basaglar in August 2014, pending a patent lawsuit between Lilly/BI and Sanofi. That lawsuit is now settled, allowing Lilly/BI to launch Basaglar starting December 15, 2016.

Basaglar is the first “biosimilar” insulin product to be approved in the US, and despite the delay, is expected to be the first biosimilar insulin to launch in the US as well. Other companies including Mylan/Biocon and Merck/Samsung Bioepis are working on their own biosimilar insulin glargine products. Sanofi is also developing a biosimilar version of Lilly’s rapid-acting insulin Humalog (insulin lispro). –ER/AJW