MDC to call Sanofi India in next meeting before price fixation of its anti-diabetes combination

The Multi Disciplinary Committee (MDC) of Experts, which advices the National Pharmaceutical Pricing Authority (NPPA) on pricing related matters, has decided to call Sanofi India in its next meeting to present the company’s case with regard to its application for higher price for certain combinations of its diabetes drug Soliqua.

The company applied for retail price fixation of a combination of insulin glargine 100 U and lixisenatide 0.05 mg and insulin glargine 100 U and lixisenatide 0.33 mg, at Rs 587.30 per ml excluding Goods and Services Tax (GST).

The Committee noted that insulin glargine 100 IU is a schedule formulation and its present applicable ceiling price is Rs 181.45 per ml.

Further, Lixinsenatide is a non-scheduled formulation and is a product of Sanofi India which has limited sales according to data from Pharmatrac, a product from market intelligence firm PharmaTrac AWACS, which is relied on by the Authority for price fixation.

Considering the request, the Committee directed that Sanofi India may be called in the next MDC meeting to present its case with regards to market dynamics of Lixisenatide. Besides, it would also look into the therapeutic advantage of the Fixed Dose Combination (FDC) of lixisenatide and insulin glargine over the schedule formulation of insulin glargine.

According to data from Pharmatrac, the company has sold seven units of lixinsenatide 10 mcg between September, 2020 to August, 2021 for a total value of Rs 22,000 and six units between September, 2021 and August, 2022 for a total of Rs 19,000 while for the year September, 2022 to August, 2023 no sales has been reported.

For Lixisenatide 20 mcg, between September, 2020 and August, 2021 the company sold 620 units for a total value of Rs 19.43 lakh, and between September, 2021 and August, 2022, a total of 210 units for Rs 6.58 lakh. The data shows there were no sales of this formulation also between September, 2022 and August, 2023.

Suliqua is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus to improve glycaemic control as an adjunct to diet and exercise in addition to metformin with or without sodium-glucose co-transporter-2 (SGLT-2) inhibitors.

Sanofi India, in March, 2023 announced that it has received marketing authorisation from the Central Drugs Standard Control Organisation (CDSCO) for the diabetes drug Soliqua in pre-filled pen.

“Soliqua is indicated as 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,” said the company during the time.

Cyrus Aibara, Head – Diabetes Business Unit, Sanofi (India) during the announcement said, “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 people with obesity 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) during the time added, “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.”

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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