Insulin lispro biosimilars
The first fast-acting insulin analogue, with two European biosimilars, none yet under the US biosimilar pathway, and Indian supply through imports.
About insulin lispro
Insulin lispro was the first modified insulin designed to act quickly at mealtimes. Two building blocks of the insulin chain are swapped, which stops the molecules clumping so they are absorbed within minutes.
Taken just before eating, it covers the rise in blood sugar from the meal and wears off within a few hours, reducing the risk of low blood sugar later.
An injection under the skin before meals, from pens, cartridges or vials, and used in pumps. Premixed forms with a slower insulin exist for twice-daily use.
Type 1 and type 2 diabetes in adults and children who need mealtime insulin.
As for other insulins, a biosimilar is compared in the laboratory, in clamp studies in volunteers, and in a safety study in people with type 1 diabetes, with full testing of the pen.
The reference product is Humalog, from Eli Lilly. Sanofi's copy is a biosimilar in Europe but reached the United States through the older drug route, so it is not counted as a biosimilar there.
One insulin lispro is a biosimilar in Europe and not in the United States. No lispro has yet been approved under the US biosimilar pathway. India is supplied through Cipla's and Lupin's imports rather than domestic manufacture.
Clinical details are summarised from the reference product's prescribing information. Approval dates, numbers and presentations are in the tables below, each with its source.
Competitive outlook
- Todayfour insulin lispro biosimilars are approved in at least one of the seven markets.
- Nearest to marketGan & Lee insulin lispro, Wockhardt insulin lispro have reached phase 3, the last trial before a filing.
- If all of them arriveThe approved count would rise from four to six.
No published switching study for this molecule yet.
Approvals by year
Regulatory register
| Regulator | Brand | Holder or applicant | Approved | Application or permission | US licence | Status | Source |
|---|---|---|---|---|---|---|---|
| EMA | Insulin lispro Sanofi | Sanofi Winthrop Industrie | Jul 2017 | EMEA/H/C/004303 | Approved | S017 | |
| EMA | Bysumlog | Gan & Lee Pharmaceuticals Europe GmbH | May 2026 | EMEA/H/C/006158 | Approved | S017 | |
| MHRA | Admelog | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| PMDA | Insulin Lispro BS HU Sanofi | Sanofi K.K. | Mar 2020 | not published | Approved | S020 | |
| HC | Admelog | Sanofi-aventis Canada INC | Nov 2017 | DIN 02469898, 02469901, 02469871 | Approved | S022 | |
| CDSCO | Cipla (INN only) | Cipla Limited | Sep 2021 | IMP/BIO/21/000084 (25/75 premix, September 2021) | Approved | S012 | |
| CDSCO | Lupin (INN only) | Lupin Limited | Apr 2024 | IMP/BIO/24/000038 | Approved | S012 |
Last checked Sep 2026. US interchangeability designations are listed in full on the interchangeable biosimilars page. CDSCO lists permissions by firm and INN, not brand. PMDA's list and the UAE directory do not publish application numbers; Canadian dates are the first approval or market date recorded in the Drug Product Database.
Regulatory pathway by market
Requirements for an insulin lispro biosimilar under the guidance in force in September 2026.
| FDA, United States | EMA, European Union | MHRA, United Kingdom | PMDA, Japan | Health Canada | CDSCO, India | EDE, UAE | |
|---|---|---|---|---|---|---|---|
| Legal pathway | Section 351(k), open to insulins since 23 March 2020; no insulin lispro has yet been approved under it | Article 10(4) of Directive 2001/83/EC; centralised procedure is mandatory for biotechnology products | UK marketing authorisation from MHRA. EU approvals in force at the end of 2020 became Great Britain licences automatically; new products since 2021 are approved through reliance on EMA or FDA decisions, and from 2024 through the International Recognition Procedure. Northern Ireland follows EU licences | MHLW approval on PMDA review under the Guideline for Ensuring Quality, Safety and Efficacy of Biosimilars (2009, revised 2020), with Q&A updates in 2024 and 2026 | Notice of Compliance under the Food and Drug Regulations as a biosimilar biologic drug, assessed under Health Canada's guidance on biosimilars (2016, revised 2022 and 2026) | Guidelines on Similar Biologics (CDSCO and DBT, 2016, in force); revised draft published May 2025 | Registration through the Emirates Drug Establishment; the public directory does not distinguish biosimilars from other biologicals |
| Reference product | US-licensed reference; a non-US comparator may be used with analytical and PK bridging | EU-authorised reference; a non-EEA comparator may be used with bridging data | Reference biologic authorised in the UK, or an EU-authorised version with bridging data | The original biopharmaceutical approved in Japan; foreign-sourced reference accepted with bridging since the 2020 revision | Reference biologic drug authorised in Canada, or a non-Canadian version of it with bridging data | Product licensed in India, or if not, one licensed in an ICH country, with justification | Not stated in the public directory; registration relies on assessment by reference regulators |
| Comparative clinical study | Draft guidance (October 2025): comparative analytical assessment plus a PK similarity study and immunogenicity assessment; a comparative efficacy study is generally not needed | Reflection paper adopted March 2026: a comparative efficacy trial can be waived when analytical and PK comparability is sufficient | Follows the EU guideline; MHRA's 2021 biosimilar guidance states that a comparative efficacy trial is generally not needed where analytical and pharmacokinetic comparability is shown | Comparative PK study and, in principle, a comparative efficacy study; the May 2026 early consideration sets out when the efficacy study can be omitted, and Japanese patient data are no longer required in every case (2025) | Comparative structural and functional studies, PK and, where warranted, PD equivalence; the 2026 revision reduces the expectation of comparative efficacy trials in line with FDA and EMA | Comparative PK/PD study and a comparative safety and efficacy study are generally expected, followed by a post-marketing study | Assessed on the dossier accepted by the reference regulator |
| Interchangeability | A separate designation permitting pharmacy-level substitution; switching studies generally not required under the June 2024 draft | EMA and HMA statement (September 2022): EU biosimilars are interchangeable with their reference; substitution rules are set by each member state | No designation; MHRA considers approved biosimilars interchangeable with their reference, and switching is decided by the prescriber and by NHS commissioning | Not defined; prescribing by brand, with pharmacist substitution not automatic | No federal designation; substitution and mandatory switching policies are set by each province, several of which have required switching since 2019 | Not defined in the guidelines | Not defined |
| Naming | INN plus a four-letter suffix | INN, identical to the reference; brand name and batch recorded for pharmacovigilance | Brand name with the non-proprietary name; licence numbers PL, PLGB or PLNI | INN followed by BS (biosimilar), strength, form and the company name in quotation marks, with a biosimilar number in the non-proprietary name | Non-proprietary name identical to the reference, with brand name and DIN as identifiers | INN with the brand name | Brand name as registered |
Sources: FDA draft guidance on comparative efficacy studies (October 2025) and interchangeability (June 2024); EMA reflection paper EMA/CHMP/BMWP/60916/2025 (March 2026) and EMA/HMA statement on interchangeability (September 2022); CDSCO Guidelines on Similar Biologics 2016 and 2025 draft (S009, S010); EDE directory (S018); MHLW/PMDA biosimilar guideline and notifications (S021); Health Canada guidance on biosimilar biologic drugs; MHRA guidance on the licensing of biosimilar products (2021).
EvySaif prepares the comparative evidence plan and the regional dossier strategy for insulin lispro programmes. Regulatory strategy consulting
Presentations and concentration
100 units/mL in vials, cartridges and pre-filled pens; 200 units/mL in pens. Premixes are 100 IU/mL suspensions at 25/75 or 50/50 lispro to lispro protamine.
| Product | FDA | EMA | MHRA | PMDA | HC | CDSCO | EDE |
|---|---|---|---|---|---|---|---|
| Insulin lispro Sanofi SAR342434 | · | see SmPC | 100 units/mL cartridge, pen and vial | SoloStar pen, cartridge, 100 U/mL vial | 100 units/mL | · | · |
| Bysumlog | · | see SmPC | · | · | · | · | · |
| Cipla insulin lispro | · | · | · | · | · | 100 IU/mL cartridge and pen; 200 U/mL pen; 25/75 and 50/50 premixes; ultra-rapid 100 U/mL (2023) | · |
| Lupin insulin lispro | · | · | · | · | · | 3 mL cartridge and pre-filled pen; 25/75 and 50/50 premixes | · |
EU presentations are listed in each product's SmPC.
Developers by market
| Developer | Product | FDA | EMA | MHRA | PMDA | HC | CDSCO | EDE |
|---|---|---|---|---|---|---|---|---|
| Sanofi | Insulin lispro Sanofi | · | ✓ | ✓ | ✓ | ✓ | · | · |
| Gan & Lee Pharmaceuticals | Bysumlog | · | ✓ | · | · | · | · | · |
| Not stated in the CDSCO list | Cipla insulin lispro | · | · | · | · | · | ✓ | · |
| Not stated in the CDSCO list | Lupin insulin lispro | · | · | · | · | · | ✓ | · |
Entering a market where a competitor is already listed changes the evidence and pricing conversation. EvySaif's global value dossier and HTA submission work covers that side.
Products
Insulin lispro Sanofi
Bysumlog
Cipla insulin lispro
Lupin insulin lispro
In development
ClinicalTrials.gov holds two comparative trials of two insulin lispro biosimilar candidates against the reference product, run by two sponsors. None of the candidates (Gan & Lee insulin lispro, Wockhardt insulin lispro) has an approval yet in any of the seven markets. Trials are listed with the sponsor's own wording for status and dates.
| Candidate | Developer or sponsor | Reference product | Phase | Design | Registry status | Started | Primary completion | In the Atlas | Registry record |
|---|---|---|---|---|---|---|---|---|---|
| Gan & Lee insulin lispro | Gan & Lee Pharmaceuticals | Humalog | Phase 3 | Comparative efficacy | Withdrawn | Dec 2019 | Jan 2020 | no approval in the seven markets | NCT04254380 |
| Wockhardt insulin lispro | Wockhardt | Humalog | Phase 3 | Comparative efficacy | Withdrawn | Feb 2012 | Mar 2013 | no approval in the seven markets | NCT01398670 |
Registry data from ClinicalTrials.gov, entered by the sponsors and not verified by any regulator. Status and dates are as posted; sponsors often update them late. Trials registered only on other registries, such as India's CTRI or China's ChiCTR, are not included. Checked 12 Sep 2026. The full list across all molecules is on the pipeline page.
Questions
Is there an insulin lispro biosimilar in the United States?
Not under the biosimilar pathway. Sanofi's Admelog was approved through the drug route before insulins became biologics, and Lilly sells its own unbranded version of Humalog.
Which insulin lispro biosimilars are approved in Europe?
Sanofi's product, since 2017, and Gan & Lee's Bysumlog, since 2026.
Is there an insulin lispro biosimilar in India?
Through imports. Cipla and Lupin hold permissions for the standard and premixed forms. No domestic manufacturing permission appears in the published lists.
Why is Admelog not a biosimilar in the United States?
It was approved in 2017 under the drug law, using Humalog as the listed drug, because insulins were regulated as drugs until 2020.
Which insulin lispro biosimilars are registered in the UAE?
None yet. Humalog and its premixed and faster forms are registered.
How is an insulin lispro biosimilar tested?
Laboratory comparison, clamp studies in volunteers, a safety study in people with type 1 diabetes, and testing of the pen.
Work with EvySaif on insulin lispro
Insulin lispro biosimilar landscape report
The register on this page as a delivered document: every approval, holder, presentation and pathway requirement across FDA, EMA, CDSCO and the Gulf, updated to the month, with the sources attached.
Request the landscape reportRegulatory gap assessment
For a developer deciding whether and where to file: a review of your analytical, PK and clinical package against what each regulator expects for insulin lispro, with the gaps ranked and a filing sequence recommended.
About the gap assessmentSources
S017EMA, medicines data table (medicines-output-medicines-report_en.xlsx) Primary (regulator)S012CDSCO, new drugs (r-DNA origin) approved for import and marketing, Jan 2020 to June 2026 (CT-18) Primary (regulator)S020PMDA, list of approved biosimilar products in Japan (as of July 2026) Primary (regulator)S022Health Canada, Drug Product Database data extract (active and inactive product files, biosimilar table) Primary (regulator)S023MHRA Products, substance lists of licensed medicines (products.mhra.gov.uk) Primary (regulator)S016FDA Purple Book, monthly data downloads January to August 2026 Primary (regulator)S018UAE Emirates Drug Establishment, registered medical product directory Primary (regulator)S013CDSCO, import and market permissions till 2019 (r-DNA) Primary (regulator)S009CDSCO and DBT, Guidelines on Similar Biologics 2016 Primary (regulator)S010CDSCO, Draft Guidelines on Similar Biologics 2025 Primary (regulator)S024ClinicalTrials.gov, study records (API v2, one query per molecule with the term biosimilar) Registry (sponsor-entered)
Planning insulin lispro biosimilar development?
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