Insulin goes generic

Viatris’s Semglee was first approved last year, but its new interchangeable label means that it can be substituted for the reference product, Sanofi’s long-acting Lantus, at US pharmacies, like a generic. The FDA believes that this direct competition will cut prices; the amount US patients pay for insulin products has surged over the past few years. According to GoodRx, when bought without insurance a vial of Lantus costs around $190, versus around $110 for Semglee, though this pricing does not appear to take account of the new approval. But when a patient has insurance or Medicare coverage the calculation can become more complicated. In Sanofi's 2021 pricing report the company said that since 2012 the amount it received for Lantus had fallen 45% – but the average out-of-pocket cost for Lantus patients with commercial insurance and Medicare had risen 82%. Availability of a cheaper generic might simply mean that patients pay a similar amount and insurers pocket the difference. Perhaps more generics might help. Viatris will have a year on the market with Semglee before the FDA can approve another interchangeable biosimilar, but several non-interchangeable ones are available around the world, and some might eventually attain this additional label. 

Biosimilar versions of Sanofi's Lantus (insulin glargine)
Company Product  Status
Viatris Semglee, Basalog Launched in India in 2009, Japan in 2016, S Korea & UK in 2018 and Australia in 2019; approved in EU in 2018; approved in the US in 2020 and as interchangeable in 2021
Lilly/Boehringer Ingelheim Basaglar, Abasaglar Launched in South Korea in 2017; approved in EU & US in 2014 and in Australia & Japan in 2015
Samsung Bioepis Lusduna  Approved in Europe in 2017; tentative US approval for follow-on biological granted in 2017
Gan & Lee Basalin Launched in China in 2005
Wockhardt Glaritus Launched in India in 2009
Kalbe Pharma Ezelin Launched in Indonesia in 2017
GC Pharma Glarzia Launched in S Korea in 2018
Source: the Generics and Biosimilar Initiative

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