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Sanofi receives marketing approval for its diabetes drug Soliqua™ in India

Pre-filled pens containing a combination of insulin glargine 100 Units/mL and lixisenatide for once-daily dosing

Sanofi (India) announced that it has received marketing authorization for its diabetes drug Soliqua™ (in a pre-filled pen) from the Central Drugs Standard Control Organization (CDSCO). Soliqua™ is indicated as a treatment to improve glycemic control as an adjunct to diet and exercise, in adults with obesity and type 2 diabetes who are insufficiently controlled on oral or injectable therapies. It comes in once-daily dosing of pre-filled pens in fixed-ratio combination (10-40 and 30-60) of insulin glargine and lixisenatide.

Cyrus Aibara

Head – Diabetes Business Unit, Sanofi (India)

“With approximately 74 million Indians* (between the ages of 20-79 years) living with diabetes, healthcare professionals need more treatment options to customize diabetes care for them. Soliqua™ is the latest addition to our comprehensive diabetes portfolio (OADs and insulins) indicated for obese people who are living with insufficiently controlled diabetes. It will allow physicians to provide more tailored solutions for better diabetes management.”

Dr. Shalini Menon

Country Medical Lead, Sanofi (India)

“Concerns about hypoglycemia and weight gain are known barriers when advancing diabetes treatments, more so when intensifying to a complex insulin regime. The global Solimix study** that included Indian patients, demonstrated that once daily Soliqua™ provides with weight benefit and less hypoglycaemia when compared with twice daily premixed insulin – thereby becoming a valuable option for endocrinologists.”

Soliqua™ (10-40 and 30-60 prefilled pens) is a once-daily injectable combination drug containing insulin glargine 100 Units/ml, which is a long-acting basal insulin and lixisenatide, a GLP-1 receptor agonist.

Sanofi – in India for India

Since 1956, Sanofi has earned the trust as well as a place in 1-in-3 Indian households (if not more). Pain management (Combiflam®), respiratory allergies caused by pollution (Allegra®), vitamin D deficiency (Depura®), diabetes (Lantus® – insulin glargine), flu prevention (FluQuadri® vaccine) and rare diseases (4 first & best-in-class therapies) are significant health issues, and our portfolio helps prevent, treat or optimally manage them. Six of our brands feature amongst India’s Top 200 pharmaceutical brands*. Sanofi also provides devices (insulin pens), counselling (Saath7 for patients on Lantus®), diagnostic services for rare diseases (Disha), health education and awareness (mass & social media and in-clinic), and capacity building (HCPs & educators) in order to provide people in India holistic care for better disease outcomes. Our India Charitable Access Program is the country’s longest running humanitarian program providing free treatment to people afflicted with Lysosomal Storage Disorders. We conduct clinical trials here so that India can have quicker access to the latest from our global pipeline. Our world-class manufacturing site in Goa produces for people in India and 60+ other countries.

We operate through two local entities, namely Sanofi India Limited and Sanofi Healthcare India Pvt. Ltd. Sanofi is one of India’s most admired healthcare companies because we produce high quality products, have strong ethical values, run social impact programs (primarily in Type 1 diabetes and rare diseases), and have employee programs that enable professional growth, and a culture where our employees have camaraderie and share their passion for excellence. Sanofi India has been recognized by the ‘Top® Employers Institute’ for 5 years in a row (since 2019).

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* Indian Pharma Market as per IQVIA data MAT Dec’22.

About Sanofi

We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people’s lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions.

*International Diabetes Federation’s Diabetes Atlas (10th edition)

**Solimix is a 26-week, open-label, multi-center study, in adults with sub-optimally controlled basal insulin-treated type 2 diabetes (


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