Insulin lispro Sanofi - supply shortage
Ongoing
insulin lispro
ShortageHuman
Shortage information
A shortage of the following presentations of Insulin lispro Sanofi is expected to affect some EU/EAA Member States starting in the first quarter of 2026:
- Insulin Lispro Sanofi 100 units/ml solution for injection in cartridges; and
- Insulin Lispro Sanofi 100 units/ml solution for injection in pre-filled pen.
Insulin Lispro Sanofi 100 units/ml solution for injection in vial is not impacted.
The expected duration of the shortage is unknown.
Insulin lispro Sanofi is a medicine used to control blood glucose (sugar) levels in adults and children with diabetes who need insulin. It contains the active substance insulin lispro.
Insulin lispro Sanofi is a ‘biosimilar medicine’. This means that it is highly similar to a biological medicine (also known as the ‘reference medicine’) that is already authorised in the European Union (EU). The reference medicine for Insulin lispro Sanofi is Humalog 100 U/ml solution.
For further information on the use of the medicine please refer to the medicine’s overview page.
There has been an unprecedented increase in demand for all insulins marketed by Sanofi. Sanofi is unable to immediately adapt and increase its supply for the affected presentations of Insulin lispro Sanofi. This will lead to a supply shortage of these formulations of Insulin lispro Sanofi. It is not known how long the shortage will last. The supply shortage is not related to a quality defect or safety or efficacy concerns.
The shortage will affect several of the EEA countries where the product is marketed.
For up-to-date information about the status of a medicine shortage in a particular Member State/EEA country, consult the national shortage register or contact the national competent authority.
EMA’s Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) and EMA’s shortages working party (Medicines Shortages Single Point of Contact – SPOC - working party) are closely monitoring the supply situation and engaging with the marketing authorisation holder and other stakeholders to mitigate the impact of the supply shortage.
The SPOC Working Party Supports EMA’s MSSG and monitors and reports events that could affect the supply of medicines in the EU.
- During the shortage no new patients should be started on the affected presentations of Insulin lispro Sanofi.
- Patients who are currently receiving treatment with the affected presentations of Insulin Lispro Sanofi should be switched to alternative insulin lispro-containing products or to products containing other rapid-acting insulin analogues (a modified version of human insulin which acts faster; e.g. insulin aspart or insulin glulisine).
- If switching patients to another rapid-acting insulin take the following into consideration:
- Alternative rapid-acting insulins provide comparable glycemic control but may require individualised dose adjustments due to differences in insulin pharmacokinetics, specifically onset, peak, and duration of action;
- Provide clear instructions on the use of any new insulin delivery system. This includes a potential need for a change in dose and additional glucose monitoring;
- Close glucose monitoring is recommended during the switch to alternative fast-acting insulin analogues and in the first week or at the discretion of the healthcare provider thereafter, especially in pregnant women and children who may need closer monitoring than the general population. The risk of hypoglycaemia may be higher in these populations;
- Follow dosing recommendations in relevant summary of product characteristics while switching patients to alternative fast-acting insulin analogs.
- A medicine shortage communication (MSC) has been sent to healthcare professionals in affected Member States and will also be published on the EMA website.
- You may also contact relevant healthcare professional organisations for further information. A list of European not-for-profit organisations EMA engages with can be found on the EMA website.
- For additional information consult your country’s shortage register or contact your national competent authority.
- If you are a patient using Insulin lispro Sanofi, contact your pharmacy or doctor well before your current supply runs out.
- Your healthcare professional will advise you if the Insulin lispro Sanofi you are using is affected by the shortage and will switch you to an alternative insulin, if needed.
- If your healthcare professional changes your insulin, they will explain any changes to you and ensure that you are given adequate training on how to use any new insulin delivery system.
- If you are being switched to another insulin, you should closely monitor your blood glucose levels during the transfer to another type or brand of insulin. Your healthcare professional will let you know how long you will need to closely monitor your blood glucose levels. This is especially important if you are pregnant or under 18 years of age as you may be at a higher risk of hypoglycaemia (low blood sugar levels).
- If you have any questions, speak to your doctor or pharmacist.
- You may also contact relevant patients’ organisations for further information or support. A list of European not-for-profit organisations that EMA engages with can be found on the EMA website.
For additional information, consult your country’s shortage register or contact your national competent authority.
Key facts
- Medicines affected
- Insulin lispro Sanofi
- Supply shortage status
- Ongoing
- International non-proprietary name (INN) or common name
- insulin lispro
- Pharmaceutical forms affected
- Solution for injection in a cartridge
- Solution for injection in pre-filled pen
- Strengths affected
- 100 units/ml solution for injection in cartridges
- 100 units/ml solution for injection in pre-filled pen
- Availability of alternatives
- Yes
Key dates
- Expected resolution
- The expected duration of the shortage is unknown.
- First published