Bangalore-based bio pharmaceutical major Biocon and its US-based partner Mylan have won a litigation in a US court which invalidates a Sanofi patent on a device to deliver insulin glargine.
This takes Bicon a step closer to commercialise its glargine biosimilar Semglee in the US.
US District Court of New Jersey found the device patent claims (US Patent No. 9526844) asserted by Sanofi against Biocon and Mylan’s insulin Glargine product ‘not infringed’ and ‘invalid’ for lack of written description.
Diabetes patients in parts of Europe, Australia, India and key emerging markets are already benefiting from insulin glargine.
Once approved and commercialised, Semglee will expand access to this therapy. Semglee is co-developed with Mylan in the US.
The 505(b)(2) New Drug Application (NDA) for Semglee is under active review by the US food and drug administration (USFDA).
The USFDA has set a target action date for our Insulin Glargine application in June 2020
The commercialisation of Semglee is likely to happen by the second half of this year. The market opportunity for the insulin in the US is estimated at $2.2 billion.
It treats adults with Type 2 diabetes and adults and paediatric patients with Type 1 diabetes for the control of high blood sugar.
Biocon’s Insulin Glargine has received regulatory approval in 70 countries and has been commercialised in markets such as Japan, Australia, Brazil, Mexico, and UAE.
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