Company: SNY
Filing Date: 2025-02-13
Form Type: 20-F
Source: 0001121404-25-000010
Chunk: 71

Company: Sanofi
Filing Date: 2025-02-13
Form: 20-F
Chunk 71
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 treatment and a well-established safety profile. Approved in the US and the EU in 2000 and in Japan in 2008, Lantus is available in over 130 countries worldwide. Two insulin glargine biosimilars are available in the US, two in European markets , and two in Japan. Toujeo Toujeo (insulin glargine 300 units/mL) is a long-acting analog of human insulin, indicated for the treatment of diabetes mellitus in adults. Toujeo has been granted marketing authorization by the FDA (February 2015), the EC (April 2015), and the Ministry of Health, Labor and Welfare (J-MHLW) in Japan, where its approved brand name is Lantus XR (July 2015). Toujeo has now been launched in more than 60 countries, including China since the end of 2020. In January 2020, the EC approved an expansion of the indication to include the treatment of diabetes in adolescents and children (aged six years and above). Toujeo is available in Toujeo Solostar, a disposable prefilled pen which contains 450 units of insulin glargine and requires one- third of the injection volume to deliver the same number of insulin units as Lantus Solostar. In the US (since 2018) and the EU (since 2019), Toujeo is also available in a disposable prefilled pen which contains 900 units of insulin glargine. In India, Toujeo is also available in a dedicated 450-unit cartridge in combination with a dedicated reusable pen (TouStar). Lovenox/Clexane Lovenox or Clexane (enoxaparin sodium) is a low molecular weight heparin (LMWH) indicated for the prophylaxis and treatment of venous thromboembolism and in the treatment of acute coronary syndrome. In the US, enoxaparin generics are available, while biosimilar enoxaparin medicines have gradually become available across various European countries and in a growing number of international markets, including China. Lovenox or Clexane is marketed in more than 100 countries. Plavix/Iscover Plavix or Iscover (clopidogrel bisulfate) is a platelet adenosine diphosphate (ADP) receptor antagonist. It is indicated for the prevention of atherothrombotic events in patients with a history of recent myocardial