Viatris (formerly Mylan) and Biocon have launched two versions of their interchangeable biosimilar Semglee (insulin glargine) on the US market, at different price points, in order to accommodate rebates and increase market share.
Semglee is a biosimilar insulin glargine, a long-acting basal insulin analogue which can be given once daily to help control blood sugar levels in patients with diabetes. It was the first biosimilar to be approved as interchangeable by the US Food and Drug Administration (FDA) [1]. This means it can be substituted for the reference product (Lantus) without the intervention of the prescriber, i.e. at the pharmacy level.
Interchangeable Semglee, which is produced by US-based drugmaker Viatris and partner, India-based biologicals specialist Biocon, has now launched on the US market.
However, the product has been launched as two separate versions: one branded and one unbranded. Either can be substituted for Lantus at the pharmacy level, but they have very different prices.
The unbranded version (insulin glargine) has a wholesale acquisition cost (WAC) 65% cheaper than Lantus (US$147.98 vs US$425.31 per package) and is the overall lowest WAC for any insulin glargine pen on the US market. The branded version, Semglee, however, has a WAC only slightly lower than Lantus (US$404.04 per package).
This curious strategy is an attempt to increase market share. Providing two versions of the same product at different prices allows Viatris/Biocon to cover both sections of the diabetes market, allowing payers to choose between a high price/high rebate product or a low price/low rebate product.
The high price (branded) product is currently dominating, as many commercial payers have adopted the more expensive product. This strategy is similar to Eli Lilly’s strategy with their insulin lispro product (Humalog/Lilly Insulin Lispro), and Novo Nordisk’s insulin aspart (Novology/Novo Nordisk Insulin Aspart). The strategy is used to accommodate rebates necessitated by pharmacy benefit managers (PBMs).
It was recently announced by Express Scripts, America’s largest PBM organization, that Semglee is the preferred insulin brand on its National Preferred Formulary [2]. Only the high price/high rebate version is available on Express Scripts, however, the PBM Prime Therapeutics will offer both versions.
A non-interchangeable version of Semglee was approved in 2020 [3] and launched on the US market [4] at a WAC price of just US$99. The WAC increased by 300% when Semglee’s interchangeable status was confirmed.
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References
1. GaBI Online - Generics and Biosimilars Initiative. FDA approves first interchangeable insulin glargine biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Dec 17]. Available from: www.gabionline.net/biosimilars/news/fda-approves-first-interchangeable-insulin-glargine-biosimilar
2. GaBI Online - Generics and Biosimilars Initiative. Interchangeable insulin glargine biosimilar preferred on Express Scripts [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Dec 17]. Available from: www.gabionline.net/biosimilars/general/interchangeable-insulin-glargine-biosimilar-preferred-on-express-scripts
3. GaBI Online - Generics and Biosimilars Initiative. FDA approves insulin glargine biosimilar Semglee [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Dec 17]. Available from: www.gabionline.net/biosimilars/news/FDA-approves-insulin-glargine-biosimilar-Semglee
4. GaBI Online - Generics and Biosimilars Initiative. Insulin glargine biosimilar Semglee launched in US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Dec 17]. Available from: www.gabionline.net/biosimilars/news/Insulin-glargine-biosimilar-Semglee-launched-in-US
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