Enoxaparin sodium biosimilars
A blood thinner used to prevent and treat clots, treated as a biosimilar in Europe and the Gulf and as a generic drug in the United States and India.
About enoxaparin sodium
Enoxaparin is a low-molecular-weight heparin, made by breaking down heparin extracted from pig intestine. It is not a protein made by cells, which is why different countries classify it differently.
It boosts a natural blood protein that switches off clotting factors, so clots are less likely to form and existing clots do not grow.
An injection under the skin once or twice a day from pre-filled syringes, in a range of strengths for prevention and treatment.
Prevention of clots after surgery and in hospital patients, treatment of deep vein thrombosis and lung clots, heart attacks and unstable angina, and clotting in dialysis circuits.
In Europe a copy is compared by detailed analysis of its sugar chains and by measuring its effect on clotting in volunteers. No clinical trial in patients has been required. In the United States, copies are generics that met a set of laboratory tests instead.
The reference product is Clexane in Europe and Lovenox in the United States, from Sanofi.
Enoxaparin is different from the other molecules here. The same product is a biosimilar in Europe, Canada and the UAE and a generic in the United States and India. Chinese manufacturers dominate supply, and the route to Europe runs through the biosimilar pathway.
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
- Todaynine enoxaparin sodium biosimilars are approved in at least one of the seven markets.
- AheadNo further candidate is visible in comparative trials or under review, so the competitive set is the approved products in the register below.
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| EMA | Thorinane | Pharmathen S.A. | Sep 2016 | EMEA/H/C/003795 | Withdrawn | S017 | |
| EMA | Inhixa | Techdow Pharma Netherlands B.V. | Sep 2016 | EMEA/H/C/004264 | Approved | S017 | |
| MHRA | Inhixa | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Ledraxen | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Arovi | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Crusia | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Ghemaxan | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| HC | Noromby | Juno Pharma Canada INC. | Oct 2020 | DIN 02506459, 02506467, 02506475, 02506483, 02506491, 02506505, 02506513 | Approved | S022 | |
| HC | Inclunox | Sandoz Canada Incorporated | Nov 2020 | DIN 02507501, 02507528, 02507536, 02507544, 02507552, 02507560, 02507579 | Approved | S022 | |
| HC | Redesca | Shenzhen Techdow Pharmaceutical CO., LTD. | Dec 2020 | DIN 02509075, 02509083, 02509091, 02509105, 02509113, 02509121, 02509148, 02509156 | Approved | S022 | |
| HC | Elonox | Fresenius Kabi Canada LTD | Oct 2022 | DIN 02532247, 02532255, 02532263, 02532271, 02532298, 02532301, 02532328 | Approved | S022 | |
| HC | Axberi | Baxter Corporation | Jul 2023 | DIN 02539977, 02539985, 02540002, 02540010, 02540045, 02540029, 02540037 | Approved | S022 | |
| EDE | Inhixa | SciencePharma Sp. z o.o., Poland (for Techdow) | Jun 2019 | not published | Registered | S018 | |
| EDE | Ledraxen | Centre Specialites Pharmaceutiques, France | Oct 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 enoxaparin sodium 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 | Not available: enoxaparin is a low-molecular-weight heparin regulated as a drug in the United States; generics are approved by ANDA, the first in 2010 | 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 | Not applicable; ANDA generics demonstrated sameness by five criteria set by FDA in 2010, without clinical trials | 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 | Not applicable; an ANDA generic is substitutable as a drug | 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 | Enoxaparin sodium, as a drug, without a biologic 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 enoxaparin sodium programmes. Regulatory strategy consulting
Presentations and concentration
Pre-filled syringes of 2,000 IU (20 mg) in 0.2 mL to 15,000 IU (150 mg) in 1 mL, at 100 mg/mL; 12,000 IU/0.8 mL and 15,000 IU/mL are the higher-strength treatment presentations.
| Product | FDA | EMA | MHRA | PMDA | HC | CDSCO | EDE |
|---|---|---|---|---|---|---|---|
| Inhixa | · | see SmPC | 2,000 to 15,000 IU syringes; 30,000 and 50,000 IU multidose | · | 100, 30, 300, 40, 60, 80 mg; 120, 150 mg | · | 2,000 IU/0.2 mL to 15,000 IU/mL PFS |
| Thorinane | · | see SmPC | · | · | · | · | · |
| Ledraxen | · | · | 2,000 to 10,000 IU syringes | · | · | · | 2,000 IU/0.2 mL to 8,000 IU/0.8 mL PFS |
| Noromby | · | · | · | · | 100, 30, 40, 60, 80 mg; 120, 150 mg | · | · |
| Inclunox | · | · | · | · | 100, 30, 40, 60, 80 mg; 120, 150 mg | · | · |
| Elonox | · | · | · | · | 100, 30, 40, 60, 80 mg; 120, 150 mg | · | · |
| Axberi | · | · | · | · | 100, 30, 40, 60, 80 mg; 120, 150 mg | · | · |
| Arovi | · | · | 2,000 to 15,000 IU syringes | · | · | · | · |
| Crusia | · | · | 2,000 to 15,000 IU syringes | · | · | · | · |
| Ghemaxan | · | · | 2,000 to 15,000 IU syringes | · | · | · | · |
EU presentations are listed in each product's SmPC.
Developers by market
| Developer | Product | FDA | EMA | MHRA | PMDA | HC | CDSCO | EDE |
|---|---|---|---|---|---|---|---|---|
| Techdow (Shenzhen Techdow Pharmaceutical) | Inhixa | · | ✓ | ✓ | · | ✓ | · | ✓ |
| Pharmathen | Thorinane | · | withdrawn | · | · | · | · | · |
| Not stated in the EDE directory | Ledraxen | · | · | ✓ | · | · | · | ✓ |
| Juno Pharma Canada | Noromby | · | · | · | · | ✓ | · | · |
| Sandoz | Inclunox | · | · | · | · | ✓ | · | · |
| Fresenius Kabi | Elonox | · | · | · | · | ✓ | · | · |
| Baxter | Axberi | · | · | · | · | ✓ | · | · |
| Not stated in the MHRA list | Arovi | · | · | ✓ | · | · | · | · |
| Not stated in the MHRA list | Crusia | · | · | ✓ | · | · | · | · |
| Not stated in the MHRA list | Ghemaxan | · | · | ✓ | · | · | · | · |
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
Inhixa
Thorinane
Ledraxen
Noromby
Inclunox
Elonox
Axberi
Arovi
Crusia
Ghemaxan
In development
No comparative trial of an enoxaparin sodium biosimilar candidate against the reference product was found on ClinicalTrials.gov with the word biosimilar in the record. That does not mean nothing is in development: programmes registered only on national registries, or under a code without the word, are not captured. See the pipeline page for how the list is built.
Questions
Is there an enoxaparin biosimilar in the United States?
No. Enoxaparin is a drug in the United States, and copies are approved as generics, the first in 2010.
Which enoxaparin biosimilars are approved in Europe?
Inhixa, from Techdow, since 2016. A second product, Thorinane, was approved the same year and later lapsed.
Is there an enoxaparin biosimilar in India?
Enoxaparin is licensed under India's general drug rules, so it does not appear in the biological permission lists. Several Indian companies sell it as a generic.
Which enoxaparin biosimilars are registered in the UAE?
Inhixa and Ledraxen, alongside Clexane.
Why does Europe treat enoxaparin as a biosimilar?
European law classes heparins as biological medicines because they come from animal tissue and cannot be fully characterised chemically. American law classes them as drugs.
How is an enoxaparin biosimilar tested in Europe?
Detailed analysis of the sugar chains, a volunteer study of its effect on clotting, and an assessment of immune reactions.
Work with EvySaif on enoxaparin sodium
Enoxaparin sodium 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 enoxaparin sodium, 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)S018UAE Emirates Drug Establishment, registered medical product directory 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)
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