EMA recommends approval of Lilly's Lantus biosimilar
- Biosimilar Lantus (insulin glargine) is the first biosimilar insulin to be recommended in the EU.
- It will be marketed as Abasria.
- Sanofi's Lantus goes off patent in Europe in May 2015.
This is a big day for the biosimilars market. Boehringer Ingelheim (BI) is one of the leading players in the emerging biosimilars industry. They are not only creating a dedicated division for development and commercialization of biosimilar products, but they already have a long history and depth of experience in biolgics manufacturing.
Lantus, which is Sanofi's top-selling drug, grossed $6.6 billion in 2013. Europe is generally ahead of the US when it comes to approving biosimilars and launching them. This situation is no different, as the patent on Lantus will not expire in the US until 2016.