Sandoz Group AG: Sandoz confirms European Commission approval for biosimilars Bysumlog (insulin lispro) and Dazparda (insulin aspart), strengthening position in diabetes

Sandoz Group AG / Key word(s): Regulatory Approval
Sandoz confirms European Commission approval for biosimilars Bysumlog (insulin lispro) and Dazparda (insulin aspart), strengthening position in diabetes

15.05.2026 / 13:00 CET/CEST

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MEDIA RELEASE

• Biosimilars Bysumlog (insulin lispro) and Dazparda (insulin aspart) approved for treatment of diabetes mellitus across all indications of respective reference medicines

• Potential to expand access to insulin treatment options for millions of diabetes patients in Europe

• Further strengthens Sandoz position in diabetes, following European Commission approval of Ondibta (insulin glargine) in January 2026

Basel, 15 May 2026 - Sandoz (SIX:SDZ/OTCQX:SDZNY), the global leader in affordable medicines, today confirms that the European Commission has granted marketing authorisation for Bysumlog (insulin lispro) and Dazparda (insulin aspart). The two biosimilar insulins, for injection in prefilled pens, are developed by Gan & Lee Pharmaceuticals.

Bysumlog is approved for the treatment and initial stabilisation of diabetes mellitus in adults and children¹, while Dazparda is approved for the treatment of diabetes mellitus in adults, adolescents and children aged one year or more². Both biosimilar insulins have equivalent efficacy and comparable safety to their respective reference medicines, Humalog* and NovoRapid**^3,4. Following these approvals, Bysumlog and Dazparda have the potential to increase competition, improve affordability and expand access to insulin treatment options for millions of people living with diabetes across Europe.

Armin Metzger, President Biosimilar Development, Manufacturing and Supply, Sandoz, said: "Diabetes and its complications can devastate the lives of patients and their families and the disease is placing growing strain on healthcare systems across Europe. As prevalence continues to rise, the need for high-quality, affordable diabetes treatments is increasingly urgent. The approvals of Bysumlog and Dazparda, alongside Ondibta earlier this year, represent a meaningful step to expand access to vital insulins and reflect our commitment to drive sustainable access to life-enhancing biosimilar medicines."

Diabetes is a chronic condition that occurs when either the pancreas does not produce enough insulin, a hormone that regulates blood glucose, or when the body cannot effectively use the insulin it produces. The disease and its complications can cause blindness, kidney failure, heart attacks, stroke and lower-limb amputation in some patients⁵. An estimated 66 million adults aged 20-79 in Europe live with diabetes and this is projected to rise by 10% to 72 million by 2050, with related healthcare expenditure approaching USD 200 billion⁶.

Sandoz entered into an agreement with Gan & Lee in December 2018 to commercialise biosimilar versions of the insulins aspart, lispro and glargine. Under the terms of the agreement, Sandoz will commercialise in Europe and other key territories around the world, while Gan & Lee is responsible for development, manufacturing and supply.

The approvals contribute to the continued Sandoz leadership and pioneering legacy in biosimilars, dating back to the introduction of the first biosimilar in 2006. They underscore the company's commitment to help millions of patients access biologic medicines sustainably and affordably through a global portfolio of 13 biosimilars, supported by an industry-leading pipeline. They further strengthen the Sandoz position in diabetes, while representing another step towards the overall strategic objective of capitalising on a projected ~USD 320 billion biosimilar market opportunity over the next 10 years⁷.

*Humalog is a registered trademark of Eli Lilly and Company
**NovoRapid is a registered trademark of Novo Nordisk A/S

About Bysumlog (insulin lispro)
Insulin lispro is a rapid-acting insulin analogue which is modified to provide plasma insulin within 10 to 15 minutes after subcutaneous injection. The insulin peak concentration appears within 30 to 70 minutes after injection and the effect of insulin lispro can last two to five hours. It can effectively control postprandial blood sugar. Insulin lispro shows the characteristics of rapid action, short duration of action and lower risk of late post-prandial and nocturnal hypoglycaemia compared with regular human insulin. It is typically used in combination with long-acting insulin to achieve both basal and postprandial blood glucose control in patients with diabetes. As a biosimilar, insulin lispro has equivalent efficacy and comparable safety to its reference medicine¹.

About Dazparda (insulin aspart)
Insulin aspart is a rapid-acting insulin analogue in which the proline at position B28 of the human insulin amino acid chain is replaced with aspartic acid, accelerating the rate of subcutaneous absorption. Following subcutaneous injection, insulin aspart has an onset of action within 10 to 20 minutes, reaches a peak effect within one to three hours post-administration, and has a duration of action of three to five hours, enabling effective control of postprandial blood glucose levels. As a biosimilar, insulin aspart has equivalent efficacy and comparable safety to its reference medicine².

DISCLAIMER
This Media Release contains forward-looking statements, which offer no guarantee with regard to future performance. These statements are made on the basis of management's views and assumptions regarding future events and business performance at the time the statements are made. They are subject to risks and uncertainties including, but not confined to, future global economic conditions, exchange rates, legal provisions, market conditions, activities by competitors and other factors outside of the control of Sandoz. Should one or more of these risks or uncertainties materialise or should underlying assumptions prove incorrect, actual outcomes may vary materially from those forecasted or expected. Each forward-looking statement speaks only as of the date of the particular statement, and Sandoz undertakes no obligation to publicly revise any forward-looking statements, except as required by law.

REFERENCES
¹ European Medicines Agency (EMA). Bysumlog (insulin lispro): Product details. Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/bysumlog [Last accessed: May 2026]
² European Medicines Agency (EMA). Dazparda (insulin aspart): Product details. Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/dazparda [Last accessed: May 2026]
³ European Medicines Agency (EMA). Humalog (insulin lispro): Product information. Available from: Humalog, INN-insulin lispro [Last accessed: May 2026]
⁴ European Medicines Agency (EMA). NovoRapid (insulin aspart): Product information. Available from: NovoRapid, INN-insulin aspart [Last accessed: May 2026]
⁵ World Health Organization. Diabetes Factsheet. Available at: Diabetes [Last accessed: May 2026]
⁶ IDF Diabetes Atlas 11th edition 2025. Available at: https://diabetesatlas.org/resources/idf-diabetes-atlas-2025/ [Last accessed: May 2026]
⁷ Data on file. Covers US and EU markets (2026-2035). Originator sales and LoE based on internal analysis of data from multiple subscription databases. Biosimilar data accessed in September 2025

ABOUT SANDOZ
Sandoz (SIX: SDZ; OTCQX: SDZNY) is the global leader in affordable medicines, with a growth strategy driven by its Purpose: pioneering access for patients. More than 20,000 colleagues of 100 nationalities work together to ensure over one billion patients are reached by Sandoz, generating substantial global healthcare savings and an even larger social impact. Its leading portfolio of approximately 1,300 medicines addresses diseases from the common cold to cancer. Headquartered in Basel, Switzerland, Sandoz traces its heritage back to 1886. In 2026, Sandoz celebrates 20 years of pioneering biosimilars, 80 years of antibiotics manufacturing and 140 years of heritage. In 2025, Sandoz recorded net sales of USD 11.1 billion.


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View original content: EQS News

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Language:	English
Company:	Sandoz Group AG
	Centralbahnstrasse 4
	4051 Basel
	Switzerland
Internet:	www.sandoz.com
ISIN:	CH1243598427
Valor:	124359842
Listed:	SIX Swiss Exchange
EQS News ID:	2321852

End of News	EQS News Service

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2321852 15.05.2026 CET/CEST