Insulin glargine biosimilars
A long-acting insulin taken once a day, the first insulin to have biosimilars in every major market, and India's most crowded biosimilar segment.
About insulin glargine
Insulin glargine is a modified human insulin that is absorbed slowly and evenly after injection, so one dose lasts about a day. It is the background, or basal, insulin used by millions of people with diabetes.
The modification makes the insulin form tiny crystals under the skin, which dissolve slowly. That gives a flat, steady supply over twenty-four hours without the peaks of older insulins.
Once a day by injection, from cartridges, vials or pre-filled pens. The pen is part of the product, and regulators test it as carefully as the insulin inside.
Type 1 and type 2 diabetes in adults and children who need a background insulin.
A biosimilar insulin is compared in the laboratory and in clamp studies, where volunteers' blood sugar is held steady while the insulin's effect is measured precisely. A study in people with type 1 diabetes checks safety and immune reactions. Clinical trials of blood sugar control are no longer expected.
The reference product is Lantus, from Sanofi. Its patents expired in Europe in 2014 and the first biosimilar followed that year. In the United States, insulins were regulated as drugs until 2020, and the first biosimilar came in 2021.
The same insulin glargine can have a different status in different markets. Europe has had biosimilars since 2014; the United States only since 2021; India permitted its first in 2007 and now has a dozen makers and importers. Making the insulin is not the hard part; making the pen, at scale, with consistent quality, is.
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
- Todaytwelve insulin glargine biosimilars are approved in at least one of the seven markets.
- Further outSansulin Log-G is still at the pharmacokinetic stage, usually two to three years from any approval.
- If all of them arriveThe approved count would rise from twelve to thirteen.
1 published switching studies with insulin glargine biosimilars, 1 of them trials with repeated switching, and where evidence is still missing.
Approvals by year
Regulatory register
| Regulator | Brand | Holder or applicant | Approved | Application or permission | US licence | Status | Source |
|---|---|---|---|---|---|---|---|
| FDA | Semglee | Biocon Biologics Inc. | Jul 2021 | 761201 | Interchangeable | Approved | S001, S016 |
| FDA | Rezvoglar | Eli Lilly and Company | Dec 2021 | 761215 | Interchangeable | Approved | S001, S016 |
| FDA | Langlara | Sunshine Lake Pharma Co., Ltd. | Apr 2026 | 761412 | Interchangeable | Approved | S001, S016 |
| EMA | Abasaglar | Eli Lilly Nederland B.V. | Sep 2014 | EMEA/H/C/002835 | Approved | S017 | |
| EMA | Lusduna | Merck Sharp & Dohme B.V. | Jan 2017 | EMEA/H/C/004101 | Withdrawn | S017 | |
| EMA | Semglee | Biosimilar Collaborations Ireland Limited | Mar 2018 | EMEA/H/C/004280 | Approved | S017 | |
| EMA | Ondibta | Sandoz GmbH | Jan 2026 | EMEA/H/C/006136 | Approved | S017 | |
| MHRA | Abasaglar | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Semglee | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| PMDA | Insulin Glargine BS [Lilly] | Eli Lilly Japan | Dec 2014 | not published | Approved | S020 | |
| PMDA | Insulin Glargine BS FFP | Fujifilm Pharma (Biocon product) | Mar 2016 | not published | Approved | S020 | |
| HC | Basaglar | Eli Lilly Canada INC | Sep 2015 | DIN 02444844, 02444852, 02461528 | Approved | S022 | |
| HC | Semglee | Biocon SDN.BHD | Apr 2022 | DIN 02526441 | Approved | S022 | |
| CDSCO | Wockhardt (INN only) | Wockhardt Limited | Feb 2007 | MF-7206/07 | Approved | S014 | |
| CDSCO | LG Life Sciences (INN only) | LG Life Sciences | Dec 2011 | Import permission | Approved | S013 | |
| CDSCO | Lupin (INN only) | Lupin Limited | Feb 2015 | Import permission | Approved | S013 | |
| CDSCO | Basaglar | Eli Lilly and Company (India) Pvt Ltd | Aug 2017 | Import permission | Approved | S013 | |
| CDSCO | Biocon (INN only) | Biocon Limited | Aug 2018 | Import permission | Approved | S013 | |
| CDSCO | Cipla (INN only) | Cipla Limited | Aug 2023 | IMP/BIO/23/000076 (additional marketing authorisation) | Approved | S012 | |
| CDSCO | M.J. Biopharm (INN only) | M.J. Biopharm Pvt Ltd | Mar 2024 | MF/BIO/24/000037 | Approved | S011 | |
| CDSCO | Regenix Biosciences (INN only) | Regenix Biosciences Limited | Jun 2025 | MF/BIO/25/000096 | Approved | S011 | |
| CDSCO | Eris Lifesciences (INN only) | Eris Lifesciences Limited; Eris Bionxt Private Limited | Dec 2025 | MF/BIO/25/000177 | Approved | S011 | |
| CDSCO | Genesys Biologics (INN only) | Genesys Biologics Pvt Ltd | Dec 2025 | MF/BIO/25/000186 | Approved | S011 | |
| EDE | Semglee | Biocon Sdn. Bhd., Malaysia | Aug 2021 | 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 glargine 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 glargine programmes. Regulatory strategy consulting
Presentations and concentration
100 U/mL in vials, cartridges and pre-filled pens. The 300 U/mL presentation exists only for the reference product Toujeo and is not interchangeable unit for unit with 100 U/mL.
| Product | FDA | EMA | MHRA | PMDA | HC | CDSCO | EDE |
|---|---|---|---|---|---|---|---|
| Semglee MYL-1501D | 100 U/mL, 3 mL pen and 10 mL vial | see SmPC | 100 units/mL pen | Kit and 100 units/mL | 100 units/mL | 100 IU/mL cartridge | 100 U/mL |
| Rezvoglar / Abasaglar LY2963016 | 100 U/mL, 3 mL pen | see SmPC | 100 units/mL KwikPen, Tempo Pen and cartridge | Cartridges and MirioPen | 100 units/mL | 100 U/mL, 3 mL cartridge and pre-filled pen | · |
| Langlara | 100 U/mL, 3 mL pen | · | · | · | · | · | · |
| Ondibta | · | see SmPC | · | · | · | · | · |
| Lusduna | · | see SmPC | · | · | · | · | · |
| Wockhardt insulin glargine | · | · | · | · | · | 40 IU/mL and 100 IU/mL vials, 100 IU/mL cartridge and disposable pen | · |
| LG Life Sciences insulin glargine | · | · | · | · | · | 100 IU/mL vial and cartridge | · |
| Lupin insulin glargine | · | · | · | · | · | 100 IU/mL, 10 mL vial and 3 mL cartridge | · |
| Cipla insulin glargine | · | · | · | · | · | 100 U/mL, 3 mL cartridge and pre-filled pen | · |
| M.J. Biopharm insulin glargine | · | · | · | · | · | 100 IU/mL, 10 mL vial and 3 mL cartridge | · |
| Regenix insulin glargine | · | · | · | · | · | 100 IU/mL, 10 mL vial, 3 mL cartridge and disposable pen | · |
| Eris insulin glargine | · | · | · | · | · | 100 IU/mL, 3 mL cartridge, 3 mL, 5 mL and 10 mL vials, pre-filled pen | · |
| Genesys insulin glargine | · | · | · | · | · | 100 IU/mL, 3 mL cartridge | · |
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) | Semglee | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| Eli Lilly (with Boehringer Ingelheim) | Rezvoglar / Abasaglar | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | · |
| Sunshine Lake Pharma | Langlara | ✓ | · | · | · | · | · | · |
| Gan & Lee Pharmaceuticals | Ondibta | · | ✓ | · | · | · | · | · |
| Merck Sharp & Dohme (with Samsung Bioepis) | Lusduna | · | withdrawn | · | · | · | · | · |
| Wockhardt | Wockhardt insulin glargine | · | · | · | · | · | ✓ | · |
| LG Life Sciences | LG Life Sciences insulin glargine | · | · | · | · | · | ✓ | · |
| Lupin | Lupin insulin glargine | · | · | · | · | · | ✓ | · |
| Cipla | Cipla insulin glargine | · | · | · | · | · | ✓ | · |
| M.J. Biopharm | M.J. Biopharm insulin glargine | · | · | · | · | · | ✓ | · |
| Regenix Biosciences | Regenix insulin glargine | · | · | · | · | · | ✓ | · |
| Eris Lifesciences | Eris insulin glargine | · | · | · | · | · | ✓ | · |
| Genesys Biologics | Genesys insulin glargine | · | · | · | · | · | ✓ | · |
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
Semglee
Rezvoglar / Abasaglar
Langlara
Ondibta
Lusduna
Wockhardt insulin glargine
LG Life Sciences insulin glargine
Lupin insulin glargine
Cipla insulin glargine
M.J. Biopharm insulin glargine
Regenix insulin glargine
Eris insulin glargine
Genesys insulin glargine
In development
ClinicalTrials.gov holds one comparative trial of one insulin glargine biosimilar candidate against the reference product, run by one sponsor. None of the candidates (Sansulin Log-G) 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 |
|---|---|---|---|---|---|---|---|---|---|
| Sansulin Log-G | Universitas Indonesia | Lantus | Phase 2 | Comparative efficacy | Unknown, last not yet recruiting | Oct 2020 | Aug 2021 | no approval in the seven markets | NCT04591457 |
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 interchangeable biosimilar in the United States?
Semglee, Biocon's insulin glargine, in July 2021. It was the first biosimilar of any kind to receive the designation.
Is Basaglar a biosimilar?
In Europe and Canada, yes. In the United States it was approved through the older drug route before insulins became biologics, so it is a licensed insulin but not a biosimilar.
Which was the first insulin glargine biosimilar?
Wockhardt's, permitted in India in 2007. Europe's first was Abasaglar in 2014.
How is a biosimilar insulin tested?
Laboratory comparison, clamp studies in volunteers that measure the insulin's effect precisely, a safety study in people with type 1 diabetes, and full testing of the pen.
Which insulin glargine biosimilars are available in the UAE?
Semglee, from Biocon's Malaysian plant, alongside Lantus and Toujeo.
Is the 300 units per mL version available as a biosimilar?
No. The higher-concentration Toujeo is a separate product and has no biosimilar yet.
Work with EvySaif on insulin glargine
Insulin glargine 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 glargine, 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)S014CDSCO, permissions granted in Form 46 and 46A, to 2019 Primary (regulator)S013CDSCO, import and market permissions till 2019 (r-DNA) Primary (regulator)S012CDSCO, new drugs (r-DNA origin) approved for import and marketing, Jan 2020 to June 2026 (CT-18) Primary (regulator)S011CDSCO, new drugs (r-DNA origin) approved for manufacture and marketing, Jan 2020 to June 2026 (CT-21) Primary (regulator)S018UAE Emirates Drug Establishment, registered medical product directory 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)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)
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