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January 5, 2017

The first follow-on biologic insulin is launched in the US

The first “follow-on biologic” insulin in US is set to grab a significant market share in the basal insulin space.

By GlobalData Healthcare

Eli Lilly and Boehringer Ingelheim (BI) have recently announced the launch of the first follow-on biologic insulin, Basaglar (insulin glargine), in the US. Basaglar is a biologic copy, or biosimilar, of Sanofi’s Lantus (insulin glargine), a basal insulin analog used in diabetes patients that gives a long duration of action allowing for once-daily injection.

Lantus is the world's best-selling insulin brand in terms of both sales and units; however, Lantus’ patents have recently expired and in anticipation of the expiration Eli Lilly has received approval for Basaglar. Subsequently Basaglar has been launched in Europe, Japan, and now the US. In the US, Basaglar faced a patent infringement lawsuit filed by Sanofi. The infringement suit introduced an automatic hold on Basaglar by the FDA, which led to a delayed 2016 launch in the US, whereas Basaglar’s (Abasaglar in Europe) launch in Europe occurred in 2015.

In the US, Basaglar has been priced at a discount of approximately 15% to Lantus, providing the cheapest basal insulin on the market. Currently available insulin analogs such as Lantus have doubled in price in recent years, leading to increasing cost burdens for diabetic patients. As a result, the arrival of Basaglar would address some of the unmet needs for patients unable to receive reimbursement, therefore reallocating a large portion of the basal insulin market share in Basaglar’s direction.

Prior to its launch in the US, Basaglar did not undergo the abbreviated biosimilars approval pathway, but instead was submitted via a New Drug Application (NDA) as a new chemical entity. For this reason, although Basaglar is sometimes referred to as a biosimilar, technically it’s a “follow-on biologic.” Eli Lilly and BI performed a comprehensive clinical development program, not generally required for biosimilars, in order to meet the highest standards of safety, efficacy, and quality.

In addition to PK/PD studies, Phase III studies in patients with type 1 diabetes (T1D) and type 2 diabetes (T2D) were conducted and the results were submitted, using Lantus as the active comparator. Both T1D and T2D trials with Basaglar demonstrated non-inferiority results compared to Lantus, indicating that Basaglar and Lantus have equivalent efficacy.

KOLs interviewed by GlobalData have expressed their satisfaction with Basaglar’s study results and are reassured that the first follow-on biologic insulin on the US market has been developed and manufactured by pharmaceutical companies with experience in diabetes products. 

As a line of defense against Basaglar’s market entry, Sanofi has already taken measures to limit the loss of its basal insulin market share. In January 2014, Sanofi filed a suit resulting in Basaglar’s delayed launch in the US, while also developing a superior version of its Lantus product, Toujeo, a U300 insulin glargine version of Lantus (U100). Furthermore, Merck, in collaboration with Samsung Bioepis , and Biocon have joined the race to bring biosimilar insulins, including Lantus biosimilars, to market.

Thus, competition is already brewing between these multiple biologic versions of Lantus, with Eli Lilly and BI having a distinct advantage of being first to the US market. Whereas the majority of biosimilar insulins have yet to influence the US insulin market, incumbent basal insulins will already begin to experience the effects from Basaglar’s entrance. Specifically, Lantus, along with Novo Nordisk ’s Levemir (insulin detemir) and Tresiba (insulin degludec), will lose considerable market share to Basaglar.

Diabetes is a chronic disease that results from the body being unable to produce sufficient insulin or not being able to use insulin effectively. As such, insulin treatments are crucial for most diabetics. Yet, many diabetic patients are unable to afford the high cost of insulin, and therefore are prone to increased risk of complications and death. The arrival of Basaglar will finally allow for a change to occur in an otherwise expensive insulin market, providing a cheaper alternative to basal insulin users. Through addressing the unmet need for a more affordable insulin therapy, Eli Lilly and BI hope to gain considerable market share with their first follow-on biologic insulin.

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