Hier ein paar Infos zum Mitbewerberumfeld.
Auch Sanofi wird in 2-3 Jahren wohl mit einen Biosimilar Insulin Aspart (NovoRapid) auf den Markt drängen.
Es zeigt sich, dass die Entscheidung Fiasp (Faster Insulin Aspart) zu entwickeln eine gute Entscheidung war, um sich gegen den Druck durch Biosimilars etwas abzuschirmen.
Sanofi reports 12.2% decrease in diabetes sales in Q2 2017, driven by a 23% decrease in US Sanofi Q2 2017 earnings call, 31 July 2017
Sanofi expects an accelerated decline in US diabetes sales in H2 2017 First-half 2017 diabetes sales decreased 9.2% to EUR 3,310 million at constant exchange rates (CER). In Q2 2017 the US total insulin glargine sales (Lantus & Toujeo) decreased 23.9% to EUR 782 million, driven by exclusion from CVS and United Healthcare (UHC) commercial formularies. Sanofi expects accelerated decline of diabetes sales in H2 2017 due to continuing impact of UHC exclusion and high base of Q4 2016 sales; the company reiterated the expectation that diabetes performance in 2017 is likely to come in below -8% the lower end of their mid-term financial guidance. (Sanofi press release and slide presentation, 31 July 2017).
Sanofi plans to start phase 3 trial for its biosimilar aspart in early August with potential approval in Q3 2020 The randomized, open-label trial (GEMELLI 1) will recruit 500 subjects with T1DM or T2DM and compare SAR341402 (Sanofi's biosimilar aspart) to NovoRapid/NovoLog, both in combination with Lantus. Primary endpoint is change in HbA1c at 26 weeks and secondary endpoints include changes in antibody status. Completion is due in January 2019.
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