Insulin human biosimilars
Ordinary manufactured human insulin in its fast, intermediate and premixed forms, the backbone of insulin supply in India, and classed as a biosimilar only in Canada.
About insulin human
Human insulin is insulin made by bacteria or yeast to exactly match the natural hormone. It comes in a fast-acting form, a slower form mixed with a protein called protamine, and premixes of the two. It was the first medicine ever made by genetic engineering.
It replaces the insulin the body cannot make, moving sugar from the blood into muscle and fat. The three forms differ only in how quickly they are absorbed.
Injections under the skin, once to several times a day depending on the form, from vials, cartridges or pens. India still licenses a 40 units per mL strength alongside the international 100 units per mL.
Type 1 and type 2 diabetes, and diabetic emergencies where the fast form is given into a vein.
Where human insulin is assessed as a biosimilar, the comparison uses laboratory data and clamp studies in volunteers plus a safety study in patients. In Europe the two applications assessed that way were refused or withdrawn, and no human insulin biosimilar has been approved there.
The reference products are Humulin from Eli Lilly, Actrapid, Insulatard and Mixtard from Novo Nordisk, and Insuman from Sanofi.
Human insulin is the largest-volume biologic in India and one of the cheapest, so it is where new Indian manufacturers enter and where public procurement sets the price. Outside India and China it has almost no biosimilar market: Europe refused or saw withdrawn every application, the United States never received one, and Canada's single biosimilar is a ready-to-use intravenous bag.
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
- Todayten insulin human biosimilars are approved in at least one of the seven markets.
- Further outInsulex R, Julphar Insulin 30/70, Julphar Insulin R are still at the pharmacokinetic stage, usually two to three years from any approval.
- If all of them arriveThe approved count would rise from ten to thirteen.
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 | Inpremzia | Baxter Holding B.V. | Apr 2022 | EMEA/H/C/005331 | Withdrawn | S017 | |
| EMA | Solumarv | Marvel Lifesciences Ltd | not published | EMEA/H/C/003858 | Withdrawn | S017 | |
| HC | Myxredlin | Baxter Corporation | Aug 2022 | DIN 02529602 | Approved | S022 | |
| CDSCO | Gland Pharma (INN only) | Gland Pharma Ltd | Aug 2011 | MF-334/2011 | Approved | S014 | |
| CDSCO | Shantha Biotechnics (INN only) | Shantha Biotechnics Limited | Nov 2013 | MF-243/2013 | Approved | S014 | |
| CDSCO | Biocon (INN only) | Biocon Limited | Feb 2018 | Import permission | Approved | S013 | |
| CDSCO | MJ Biopharm (INN only) | MJ Biopharm Pvt Ltd | Jun 2018 | MF/BIO/18/000001 | Approved | S014 | |
| CDSCO | Epygen Biotech Private (INN only) | Epygen Biotech Private Limited | May 2021 | MF/BIO/21/000046 | Approved | S011 | |
| CDSCO | Lupin (INN only) | Lupin Limited | Jan 2024 | IMP/BIO/24/000008 (isophane) | Approved | S012 | |
| CDSCO | Cadila Pharmaceuticals (INN only) | Cadila Pharmaceuticals Limited | Nov 2024 | MF/BIO/24/000126 | Approved | S011 | |
| CDSCO | Eris Lifesciences (INN only) | Eris Lifesciences Limited; Eris Bionxt Private Limited | Dec 2025 | MF/BIO/25/000164 to MF/BIO/25/000182 (December 2025) | Approved | S011 | |
| CDSCO | Regenix Drugs (INN only) | Regenix Drugs Ltd | Apr 2026 | MF/BIO/26/000050 (biphasic) | Approved | S011 |
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 human 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 human insulin has been approved under it (Myxredlin, 2019, reached the US through the 505(b)(2) route before the transition) | 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 human programmes. Regulatory strategy consulting
Presentations and concentration
100 IU/mL is the international standard in vials, cartridges and pens; India also licenses 40 IU/mL vials. Biphasic presentations are 30/70 soluble to isophane, with 50/50 for some originators.
| Product | FDA | EMA | MHRA | PMDA | HC | CDSCO | EDE |
|---|---|---|---|---|---|---|---|
| Gland Pharma human insulin | · | · | · | · | · | Biphasic isophane 30/70 | · |
| Shantha human insulin | · | · | · | · | · | Soluble (rapid) insulin | · |
| M.J. Biopharm human insulin | · | · | · | · | · | Biphasic 30/70 | · |
| Biocon human insulin | · | · | · | · | · | 100 IU/mL, 3 mL cartridges | · |
| Epygen human insulin | · | · | · | · | · | Biphasic isophane 30/70 | · |
| Lupin human insulin | · | · | · | · | · | Isophane, biphasic 30/70 and soluble presentations | · |
| Cadila Pharmaceuticals human insulin | · | · | · | · | · | Biphasic isophane 30/70 | · |
| Eris human insulin | · | · | · | · | · | Soluble, isophane and biphasic 30/70; 100 IU/mL vials and cartridges | · |
| Regenix human insulin | · | · | · | · | · | Biphasic 30/70 and soluble insulin | · |
| Myxredlin | · | · | · | · | 1 unit/mL intravenous infusion bag | · | · |
| Solumarv | · | see SmPC | · | · | · | · | · |
| Inpremzia | · | see SmPC | · | · | · | · | · |
EU presentations are listed in each product's SmPC.
Developers by market
| Developer | Product | FDA | EMA | MHRA | PMDA | HC | CDSCO | EDE |
|---|---|---|---|---|---|---|---|---|
| Gland Pharma | Gland Pharma human insulin | · | · | · | · | · | ✓ | · |
| Shantha Biotechnics (Sanofi) | Shantha human insulin | · | · | · | · | · | ✓ | · |
| M.J. Biopharm | M.J. Biopharm human insulin | · | · | · | · | · | ✓ | · |
| Biocon Biologics | Biocon human insulin | · | · | · | · | · | ✓ | · |
| Epygen Biotech | Epygen human insulin | · | · | · | · | · | ✓ | · |
| Not stated in the CDSCO list | Lupin human insulin | · | · | · | · | · | ✓ | · |
| Cadila Pharmaceuticals | Cadila Pharmaceuticals human insulin | · | · | · | · | · | ✓ | · |
| Eris Lifesciences | Eris human insulin | · | · | · | · | · | ✓ | · |
| Regenix Drugs | Regenix human insulin | · | · | · | · | · | ✓ | · |
| Baxter | Myxredlin | · | · | · | · | ✓ | · | · |
| Marvel Lifesciences | Solumarv | · | withdrawn | · | · | · | · | · |
| Baxter | Inpremzia | · | withdrawn | · | · | · | · | · |
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
Gland Pharma human insulin
Shantha human insulin
M.J. Biopharm human insulin
Biocon human insulin
Epygen human insulin
Lupin human insulin
Cadila Pharmaceuticals human insulin
Eris human insulin
Regenix human insulin
Myxredlin
Solumarv
Inpremzia
In development
ClinicalTrials.gov holds three comparative trials of three insulin human biosimilar candidates against the reference product, run by two sponsors. None of the candidates (Insulex R, Julphar Insulin 30/70, Julphar Insulin R) 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 |
|---|---|---|---|---|---|---|---|---|---|
| Julphar Insulin R | Julphar | Humulin (as licensed reference) | Phase 1 | Comparative PK | Completed | Dec 2014 | Feb 2015 | no approval in the seven markets | NCT02634515 |
| Julphar Insulin 30/70 | Julphar | Humulin (as licensed reference) | Phase 1 | Comparative PK | Completed | Feb 2016 | Jun 2016 | no approval in the seven markets | NCT02631928 |
| Insulex R | Laboratorios Pisa | Humulin | Phase 1 | Comparative PK | Completed | Oct 2024 | Feb 2025 | no approval in the seven markets | NCT07364669 |
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 a human insulin biosimilar in the United States or Europe?
No. In the United States none has been approved under the biosimilar pathway. In Europe one application was refused and two were withdrawn.
Is human insulin made in India?
Yes, widely. Wockhardt and Biocon launched products in the early 2000s, and Gland, Shantha, M.J. Biopharm, Epygen, Cadila, Eris and Regenix have since received manufacturing permissions, with Biocon and Lupin importing.
Which human insulin biosimilars are registered in the UAE?
None. The originator brands are registered.
Why does Canada call Myxredlin a biosimilar?
Health Canada assessed Baxter's ready-to-use intravenous insulin against a reference product under its biosimilar framework. The same product in the United States was approved as a drug.
Why does India still license 40 units per mL insulin?
It was the standard in India for decades and matching syringes remain in use, so both strengths are permitted.
How is a human insulin biosimilar tested?
Laboratory comparison, clamp studies in volunteers for each form, and a safety study in patients.
Work with EvySaif on insulin human
Insulin human 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 human, with the gaps ranked and a filing sequence recommended.
About the gap assessmentSources
S014CDSCO, permissions granted in Form 46 and 46A, to 2019 Primary (regulator)S013CDSCO, import and market permissions till 2019 (r-DNA) 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)S022Health Canada, Drug Product Database data extract (active and inactive product files, biosimilar table) Primary (regulator)S017EMA, medicines data table (medicines-output-medicines-report_en.xlsx) Primary (regulator)S016FDA Purple Book, monthly data downloads January to August 2026 Primary (regulator)S018UAE Emirates Drug Establishment, registered medical product directory 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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