Insulin aspart biosimilars
A fast-acting mealtime insulin, with biosimilars from Biocon, Sanofi and Gan & Lee, and the first Indian domestic product permitted in 2021.
About insulin aspart
Insulin aspart is a modified human insulin that is absorbed quickly, so it can be injected just before a meal to cover the rise in blood sugar. It is the mealtime partner to a background insulin such as glargine.
The modification stops insulin molecules clumping together under the skin, so they enter the blood within minutes rather than the half hour older insulins take.
An injection under the skin before each meal, from pens, cartridges or vials, and also used in insulin pumps. A premixed form combines it with a slower insulin for twice-daily use.
Type 1 and type 2 diabetes in adults and children who need mealtime insulin.
A biosimilar insulin is compared in the laboratory and in clamp studies in volunteers that measure its effect precisely, with a safety study in people with type 1 diabetes and full testing of the pen. For pump use, compatibility with pumps is tested too.
The reference product is NovoRapid, sold as NovoLog in the United States, from Novo Nordisk. Europe's first biosimilar came in 2020 and the United States followed in 2025.
The same companies that copied insulin glargine have copied aspart, and the pattern repeats: Europe first, the United States only recently, and India with its own domestic maker. Biocon's Kirsty is the first interchangeable aspart in the United States and is registered in the UAE from Malaysia.
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
- Todayfive insulin aspart biosimilars are approved in at least one of the seven markets.
- With regulators nowEU application 006677, EU application 006864 are under review. A decision usually comes within a year.
- Nearest to marketI004 has reached phase 3, the last trial before a filing.
- If all of them arriveThe approved count would rise from five to eight. The applications under review are anonymous in the EMA list and are probably some of the same candidates, so seven is the more realistic figure.
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 |
|---|---|---|---|---|---|---|---|
| FDA | Merilog | Sanofi-Aventis U.S. LLC | Feb 2025 | 761325 | Biosimilar | Approved | S001, S016 |
| FDA | Kirsty | Biocon Biologics Inc. | Jul 2025 | 761188 | Interchangeable | Approved | S001, S016 |
| FDA | Garzulys | Emerge Bioscience Pte. Ltd. | Jul 2026 | 761497 | Biosimilar | Approved | S001, S016 |
| EMA | Insulin aspart Sanofi | Sanofi Winthrop Industrie | Jun 2020 | EMEA/H/C/005033 | Approved | S017 | |
| EMA | Kirsty | Biosimilar Collaborations Ireland Limited | Feb 2021 | EMEA/H/C/004965 | Approved | S017 | |
| EMA | Truvelog Mix 30 | Sanofi Winthrop Industrie | Apr 2022 | EMEA/H/C/005635 | Withdrawn | S017 | |
| EMA | Dazparda | Gan & Lee Pharmaceuticals Europe GmbH | Apr 2026 | EMEA/H/C/006187 | Approved | S017 | |
| EMA | Application 006677 | Applicant not yet named by EMA | since Nov 2025 | EMEA/H/C/006677 | Under review | S019 | |
| EMA | Application 006864 | Applicant not yet named by EMA | since Nov 2025 | EMEA/H/C/006864 | Under review | S019 | |
| MHRA | Kirsty | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Trurapi | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| PMDA | Insulin Aspart BS NR Sanofi | Sanofi K.K. | Mar 2021 | not published | Approved | S020 | |
| HC | Trurapi | Sanofi-aventis Canada INC | Oct 2020 | DIN 02506564, 02506572, 02529254 | Approved | S022 | |
| HC | Kirsty | Biocon Biologics Canada INC | Oct 2021 | DIN 02520974 | Approved | S022 | |
| CDSCO | Biogenomics (INN only) | Biogenomics Limited | Oct 2021 | MF/BIO/21/000120 | Approved | S011 | |
| CDSCO | Sanofi India (INN only) | Sanofi India Limited | May 2023 | IMP/BIO/23/000058 | Approved | S012 | |
| EDE | Kirsty | Biocon Sdn. Bhd., Malaysia | Jul 2023 | not published | Registered | S018 |
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 aspart 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 when approved insulin NDAs were deemed biologics licences | 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 aspart programmes. Regulatory strategy consulting
Presentations and concentration
All presentations are 100 units/mL in 10 mL vials, 3 mL cartridges and pre-filled pens. Biphasic insulin aspart 30 is 100 IU/mL as a suspension (30% soluble, 70% protamine).
| Product | FDA | EMA | MHRA | PMDA | HC | CDSCO | EDE |
|---|---|---|---|---|---|---|---|
| Kirsty MYL-1601D | 100 units/mL, 3 mL pen and 10 mL vial | see SmPC | 100 units/mL pen and vial | · | 100 units/mL | · | 100 units/mL |
| Merilog / Insulin aspart Sanofi SAR341402 | 100 units/mL, 3 mL pen and 10 mL vial | see SmPC | 100 units/mL cartridge, pen and vial | SoloStar pen, cartridge, 100 IU/mL vial | 100 units/mL | Biphasic 30/70, 100 IU/mL | · |
| Dazparda | · | see SmPC | · | · | · | · | · |
| Garzulys | 100 units/mL, 3 mL pen and 10 mL vial | · | · | · | · | · | · |
| Biogenomics insulin aspart | · | · | · | · | · | 100 U/mL solution; biphasic 30/70 100 IU/mL in 3 mL cartridge (2025) | · |
| EU application 006677 | · | see SmPC | · | · | · | · | · |
| EU application 006864 | · | see SmPC | · | · | · | · | · |
EU presentations are listed in each product's SmPC.
Developers by market
| Developer | Product | FDA | EMA | MHRA | PMDA | HC | CDSCO | EDE |
|---|---|---|---|---|---|---|---|---|
| Biocon Biologics (with Mylan / Viatris) | Kirsty | ✓ | ✓ | ✓ | · | ✓ | · | ✓ |
| Sanofi | Merilog / Insulin aspart Sanofi | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | · |
| Gan & Lee Pharmaceuticals | Dazparda | · | ✓ | · | · | · | · | · |
| Not stated in the Purple Book | Garzulys | ✓ | · | · | · | · | · | · |
| Biogenomics | Biogenomics insulin aspart | · | · | · | · | · | ✓ | · |
| Applicant not yet named by EMA | EU application 006677 | · | review | · | · | · | · | · |
| Applicant not yet named by EMA | EU application 006864 | · | review | · | · | · | · | · |
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
Kirsty
Merilog / Insulin aspart Sanofi
Dazparda
Garzulys
Biogenomics insulin aspart
EU application 006677
EU application 006864
In development
ClinicalTrials.gov holds two comparative trials of one insulin aspart biosimilar candidate against the reference product, run by one sponsor. None of the candidates (I004) 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 |
|---|---|---|---|---|---|---|---|---|---|
| I004 | Amphastar | NovoLog | Phase 2/3 | Switching | Completed | Apr 2026 | Jun 2026 | no approval in the seven markets | NCT07560150 |
| I004 | Amphastar | NovoLog | Phase 2/3 | Comparative efficacy | Completed | Aug 2022 | Jan 2023 | no approval in the seven markets | NCT05539872 |
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
Which was the first insulin aspart biosimilar?
Sanofi's product in Europe in 2020. In the United States, Sanofi's Merilog in February 2025.
Which was the first interchangeable insulin aspart?
Biocon's Kirsty, designated on the day of its US approval in July 2025.
Is there an insulin aspart biosimilar in India?
Yes. Biogenomics received the first domestic permission in 2021 and added a premixed form in 2025. Sanofi imports its premix.
Which insulin aspart biosimilars are registered in the UAE?
Kirsty, from Biocon's Malaysian plant, alongside NovoRapid and NovoMix.
Is there a biosimilar of the premixed form?
In India and, briefly, in Europe. Sanofi's European premix was withdrawn in 2024.
How is an insulin aspart biosimilar tested?
Laboratory comparison, clamp studies in volunteers, a safety study in people with type 1 diabetes, and testing of the pen and, where claimed, of pump use.
Work with EvySaif on insulin aspart
Insulin aspart 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 aspart, with the gaps ranked and a filing sequence recommended.
About the gap assessmentSources
S001FDA, Biosimilar Product Information (approved biosimilars table) Primary (regulator)S016FDA Purple Book, monthly data downloads January to August 2026 Primary (regulator)S017EMA, medicines data table (medicines-output-medicines-report_en.xlsx) Primary (regulator)S011CDSCO, new drugs (r-DNA origin) approved for manufacture and marketing, Jan 2020 to June 2026 (CT-21) Primary (regulator)S012CDSCO, new drugs (r-DNA origin) approved for import and marketing, Jan 2020 to June 2026 (CT-18) Primary (regulator)S018UAE Emirates Drug Establishment, registered medical product directory Primary (regulator)S019EMA, applications for new human medicines under evaluation by the CHMP, August 2026 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)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 aspart biosimilar development?
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