Adalimumab biosimilars
An antibody that blocks TNF, used across rheumatology, gastroenterology, dermatology and eye disease, and the most copied biologic in the world.
About adalimumab
Adalimumab is a fully human antibody. It was one of the first antibodies made entirely from human sequences, which is part of why it has been tolerated so well over more than twenty years of use. Patients inject it under the skin, usually once every two weeks.
It works by catching a signalling protein called TNF before it can reach the cells that drive inflammation. In diseases such as rheumatoid arthritis, Crohn's disease and psoriasis the body makes too much TNF, and removing it calms the inflammation down.
It comes as a pre-filled syringe or pen. The original version was a lower-concentration liquid. A newer higher-concentration, citrate-free version was introduced later to reduce injection pain, and most biosimilar makers now offer both.
Rheumatoid arthritis, juvenile arthritis, spondylitis, psoriatic arthritis, plaque psoriasis, hidradenitis suppurativa, Crohn's disease, ulcerative colitis and uveitis. The indications are listed in the tables below for each product and market.
Because adalimumab has been used for so long, regulators know its behaviour well. A biosimilar has to match it closely in the laboratory and show the same behaviour in the body. Comparative studies are usually run in psoriasis or rheumatoid arthritis, where a difference would show up quickly. Immune reactions to the drug are an important part of the comparison, because they vary with the formulation.
The reference product is Humira, from AbbVie. For much of the last decade it was the best-selling prescription medicine in the world. Its patents expired in Europe in 2018 and biosimilars launched there straight away. In the United States, settlement agreements with the originator held launches back until 2023, several years after the first approvals.
More companies have developed a copy of adalimumab than of any other biologic, and most of the world's biosimilar makers started with it. For a new entrant the challenge is not the science, which is well mapped, but standing out in a crowded market. India was first to approve one, in 2014, two years before the United States.
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
- Today18 adalimumab biosimilars are approved in at least one of the seven markets.
- Nearest to marketAdvixa, BCD-057, M923 have reached phase 3, the last trial before a filing.
- Further outAdalimumab Richmond, BMO-2, CinnoRA, DMB-3113, HLX03, TUR01 are still at the pharmacokinetic stage, usually two to three years from any approval.
- If all of them arriveThe approved count would rise from 18 to 27.
23 published switching studies with adalimumab biosimilars, 7 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 | Amjevita | Amgen Inc. | Sep 2016 | 761024 | Interchangeable | Approved | S001, S016 |
| FDA | Cyltezo | Boehringer Ingelheim Pharmaceuticals, Inc. | Aug 2017 | 761058 | Interchangeable | Approved | S001, S016 |
| FDA | Hyrimoz | Sandoz Inc. | Oct 2018 | 761071 | Interchangeable | Approved | S001, S016 |
| FDA | Hadlima | Samsung Bioepis Co., Ltd. | Jul 2019 | 761059 | Interchangeable | Approved | S001, S016 |
| FDA | Abrilada | Pfizer Inc. | Nov 2019 | 761118 | Interchangeable | Approved | S001, S016 |
| FDA | Hulio | Biocon Biologics Inc. | Jul 2020 | 761154 | Interchangeable | Approved | S001, S016 |
| FDA | Yusimry | Emerge Bioscience Pte. Ltd. | Dec 2021 | 761216 | Biosimilar | Approved | S001, S016 |
| FDA | Idacio | Fresenius Kabi USA, LLC | Dec 2022 | 761255 | Biosimilar | Approved | S001, S016 |
| FDA | Yuflyma | CELLTRION, Inc. | May 2023 | 761219 | Interchangeable | Approved | S001, S016 |
| FDA | Simlandi | Alvotech USA Inc. | Feb 2024 | 761299 | Interchangeable | Approved | S001, S016 |
| EMA | Amgevita | Amgen Europe B.V. | Mar 2017 | EMEA/H/C/004212 | Approved | S017 | |
| EMA | Solymbic | Amgen Europe B.V. | Mar 2017 | EMEA/H/C/004373 | Withdrawn | S017 | |
| EMA | Imraldi | Samsung Bioepis NL B.V. | Aug 2017 | EMEA/H/C/004279 | Approved | S017 | |
| EMA | Cyltezo | Boehringer Ingelheim International GmbH | Nov 2017 | EMEA/H/C/004319 | Withdrawn | S017 | |
| EMA | Hyrimoz | Sandoz GmbH | Jul 2018 | EMEA/H/C/004320 | Approved | S017 | |
| EMA | Hefiya | Sandoz GmbH | Jul 2018 | EMEA/H/C/004865 | Approved | S017 | |
| EMA | Halimatoz | Sandoz GmbH | Jul 2018 | EMEA/H/C/004866 | Withdrawn | S017 | |
| EMA | Hulio | Biosimilar Collaborations Ireland Limited | Sep 2018 | EMEA/H/C/004429 | Approved | S017 | |
| EMA | Idacio | Fresenius Kabi Deutschland GmbH | Apr 2019 | EMEA/H/C/004475 | Approved | S017 | |
| EMA | Kromeya | Fresenius Kabi Deutschland GmbH | Apr 2019 | EMEA/H/C/005158 | Withdrawn | S017 | |
| EMA | Amsparity | Pfizer Europe MA EEIG | Feb 2020 | EMEA/H/C/004879 | Approved | S017 | |
| EMA | Yuflyma | Celltrion Healthcare Hungary Kft. | Feb 2021 | EMEA/H/C/005188 | Approved | S017 | |
| EMA | Libmyris | Stada Arzneimittel AG | Nov 2021 | EMEA/H/C/005947 | Approved | S017 | |
| EMA | Hukyndra | Stada Arzneimittel AG | Nov 2021 | EMEA/H/C/005548 | Approved | S017 | |
| MHRA | Amgevita | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Hukyndra | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Hulio | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Hyrimoz | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Idacio | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Imraldi | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Yuflyma | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Qletli | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| PMDA | Adalimumab BS FKB | Fujifilm Kyowa Kirin Biologics | Jun 2020 | not published | Approved | S020 | |
| PMDA | Adalimumab BS Daiichi Sankyo | Daiichi Sankyo | Jan 2021 | not published | Approved | S020 | |
| PMDA | Adalimumab BS MA | Mochida Pharmaceutical | Mar 2021 | not published | Approved | S020 | |
| PMDA | Adalimumab BS CTNK | Nippon Kayaku (Celltrion) | Sep 2023 | not published | Approved | S020 | |
| HC | Hadlima | Samsung Bioepis CO., LTD | May 2018 | DIN 02473097, 02473100 | Approved | S022 | |
| HC | Idacio | Fresenius Kabi Canada LTD | Oct 2020 | DIN 02502666, 02502674, 02502682 | Approved | S022 | |
| HC | Amgevita | Amgen Canada INC | Nov 2020 | DIN 02459299, 02459302, 02459310 | Approved | S022 | |
| HC | Hyrimoz | Sandoz Canada Incorporated | Nov 2020 | DIN 02492156, 02492164, 02505258, 02542315, 02542323, 02542331, 02542358, 02542366 | Approved | S022 | |
| HC | Hulio | Biocon Biologics Canada INC | Nov 2020 | DIN 02502380, 02502399, 02502402 | Approved | S022 | |
| HC | Abrilada | Pfizer Canada ULC | Jan 2021 | DIN 02511045, 02511053, 02511061 | Approved | S022 | |
| HC | Yuflyma | Celltrion INC. | Dec 2021 | DIN 02523760, 02523779, 02535076, 02535084 | Approved | S022 | |
| HC | Simlandi | Jamp Pharma Corporation | Jan 2022 | DIN 02523949, 02523957, 02523965 | Approved | S022 | |
| CDSCO | Exemptia | Cadila Healthcare Ltd | Sep 2014 | MF-222/2014 | Approved | S014 | |
| CDSCO | Reliance Life Sciences (INN only) | Reliance Life Sciences Pvt Ltd | Jun 2015 | MF-150/2015 | Approved | S014 | |
| CDSCO | Mabura | Hetero Drugs Limited | Jul 2017 | MF-124/2017 | Approved | S014 | |
| CDSCO | Enzene Biosciences (INN only) | Enzene Biosciences Ltd | Oct 2022 | MF/BIO/22/000100 | Approved | S011 | |
| CDSCO | Shilpa Biologicals (INN only) | Shilpa Biologicals Pvt Ltd | Jun 2023 | MF/BIO/23/000057 | Approved | S011 | |
| CDSCO | Adfrar | Torrent Pharmaceuticals | unverified | unverified | Unverified | S006, S014 | |
| EDE | Hyrimoz | Novartis Pharmaceutical Manufacturing GmbH (Sandoz) | Oct 2019 | not published | Registered | S018 | |
| EDE | Idacio | Fresenius Kabi Austria GmbH | Mar 2024 | not published | Registered | S018 | |
| EDE | Hulio | Terumo Yamaguchi Corporation for Biocon Biologics | May 2025 | not published | Registered | S018 | |
| EDE | Amgevita | Amgen Europe B.V. | not published | 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 adalimumab 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) of the Public Health Service Act (BPCIA 2009) | 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 adalimumab programmes. Regulatory strategy consulting
Presentations and concentration
Strengths in mg per mL of fill. 40 mg in 0.4 mL is the 100 mg/mL citrate-free concentration; 40 mg in 0.8 mL is the original 50 mg/mL.
| Product | FDA | EMA | MHRA | PMDA | HC | CDSCO | EDE |
|---|---|---|---|---|---|---|---|
| Amjevita / Amgevita ABP 501 | 10/0.2, 20/0.2, 20/0.4, 40/0.4, 40/0.8, 80/0.8 | see SmPC | 20 mg, 40 mg syringes and pens; HCF 20, 40 and 80 mg | · | 50 mg | · | 40 mg pen and syringe |
| Cyltezo BI 695501 | 10/0.2, 20/0.4, 40/0.4, 40/0.8 | see SmPC | · | · | · | · | · |
| Hyrimoz / Hefiya GP2017 | 10/0.1, 10/0.2, 20/0.2, 20/0.4, 40/0.4, 40/0.8, 80/0.8 | see SmPC | 20 mg and 40 mg syringes; 40 mg/0.4 mL and 80 mg/0.8 mL syringes and pens | · | 20, 40, 80 mg | · | 40/0.8 (2019); 40/0.4 PFS and pen (2024) |
| Hadlima / Imraldi SB5 | 40/0.4, 40/0.8, 80/0.8 | see SmPC | 40 mg pen and syringe; 40 mg/0.8 mL | · | 40 mg | · | · |
| Abrilada / Amsparity PF-06410293 | 10/0.2, 20/0.4, 40/0.8 | see SmPC | · | · | 20, 40 mg | · | · |
| Hulio FKB327 | 20/0.4, 40/0.8 | see SmPC | 20 mg and 40 mg syringes; 40 mg pen; 40 mg/0.8 mL vial | 20 mg/0.4 mL and 40 mg/0.8 mL syringes; 40 mg/0.8 mL pen | 20, 40 mg | · | 20/0.4 PFS; 40/0.8 PFS and pen |
| Yusimry CHS-1420 | 40/0.8 | · | · | · | · | · | · |
| Idacio MSB11022 | 40/0.8 | see SmPC | 40 mg pen and syringe; 40 mg/0.8 mL paediatric | · | 40 mg | · | 40 mg pen and syringe |
| Yuflyma CT-P17 | 10/0.1, 20/0.2, 40/0.4, 80/0.8 | see SmPC | 20 mg, 40 mg and 80 mg syringes; 40 mg and 80 mg pens | 20 mg/0.2 mL, 40 mg/0.4 mL, 80 mg/0.8 mL syringes; 40 mg and 80 mg pens | 40, 80 mg | · | · |
| Simlandi / Hukyndra / Libmyris AVT02 | 20/0.2, 40/0.4, 80/0.8 | see SmPC | 40 mg pen and syringe; 80 mg syringe | · | 40, 80 mg | · | · |
| Exemptia / Cadalimab ZRC-3197 | · | · | · | · | · | 20 mg and 40 mg PFS (50 mg/mL) | · |
| Mabura | · | · | · | · | · | 10/0.2, 20/0.4, 40/0.8 PFS; 40/0.8 vial (50 mg/mL) | · |
| Reliance Life Sciences adalimumab | · | · | · | · | · | 20 mg and 40 mg PFS (50 mg/mL) | · |
| Enzene Biosciences adalimumab | · | · | · | · | · | 40/0.4 (100 mg/mL, 2022); 20/0.2, 40/0.4, 80/0.8 (2024) | · |
| Shilpa Biologicals adalimumab | · | · | · | · | · | 40/0.4 PFS (100 mg/mL) | · |
| Adalimumab BS Daiichi Sankyo | · | · | · | 20 mg/0.4 mL and 40 mg/0.8 mL syringes; 40 mg/0.8 mL pen | · | · | · |
| Adalimumab BS MA | · | · | · | 20 mg/0.2 mL, 40 mg/0.4 mL, 80 mg/0.8 mL syringes; 40 mg/0.4 mL pen | · | · | · |
| Qletli | · | · | 40 mg syringe | · | · | · | · |
EU presentations are listed in each product's SmPC.
Developers by market
| Developer | Product | FDA | EMA | MHRA | PMDA | HC | CDSCO | EDE |
|---|---|---|---|---|---|---|---|---|
| Amgen | Amjevita / Amgevita | ✓ | ✓ | ✓ | · | ✓ | · | ✓ |
| Boehringer Ingelheim | Cyltezo | ✓ | withdrawn | · | · | · | · | · |
| Sandoz | Hyrimoz / Hefiya | ✓ | ✓ | ✓ | · | ✓ | · | ✓ |
| Samsung Bioepis | Hadlima / Imraldi | ✓ | ✓ | ✓ | · | ✓ | · | · |
| Pfizer | Abrilada / Amsparity | ✓ | ✓ | · | · | ✓ | · | · |
| Fujifilm Kyowa Kirin Biologics | Hulio | ✓ | ✓ | ✓ | ✓ | ✓ | · | ✓ |
| Coherus BioSciences | Yusimry | ✓ | · | · | · | · | · | · |
| Fresenius Kabi (originally Merck KGaA) | Idacio | ✓ | ✓ | ✓ | · | ✓ | · | ✓ |
| Celltrion | Yuflyma | ✓ | ✓ | ✓ | ✓ | ✓ | · | · |
| Alvotech | Simlandi / Hukyndra / Libmyris | ✓ | ✓ | ✓ | · | ✓ | · | · |
| Cadila Healthcare (Zydus Lifesciences) | Exemptia / Cadalimab | · | · | · | · | · | ✓ | · |
| Hetero Drugs | Mabura | · | · | · | · | · | ✓ | · |
| Reliance Life Sciences | Reliance Life Sciences adalimumab | · | · | · | · | · | ✓ | · |
| Enzene Biosciences (Alkem) | Enzene Biosciences adalimumab | · | · | · | · | · | ✓ | · |
| Shilpa Biologicals | Shilpa Biologicals adalimumab | · | · | · | · | · | ✓ | · |
| Daiichi Sankyo | Adalimumab BS Daiichi Sankyo | · | · | · | ✓ | · | · | · |
| Mochida Pharmaceutical | Adalimumab BS MA | · | · | · | ✓ | · | · | · |
| Not stated in the MHRA list | Qletli | · | · | ✓ | · | · | · | · |
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
Amjevita / Amgevita
Cyltezo
Hyrimoz / Hefiya
Hadlima / Imraldi
Abrilada / Amsparity
Hulio
Yusimry
Idacio
Yuflyma
Simlandi / Hukyndra / Libmyris
Exemptia / Cadalimab
Mabura
Reliance Life Sciences adalimumab
Enzene Biosciences adalimumab
Shilpa Biologicals adalimumab
Adalimumab BS Daiichi Sankyo
Adalimumab BS MA
Qletli
In development
ClinicalTrials.gov holds 21 comparative trials of sixteen adalimumab biosimilar candidates against the reference product, run by fifteen sponsors. Nine of the candidates (Adalimumab Richmond, Advixa, BCD-057, BMO-2, CinnoRA, DMB-3113, HLX03, M923, TUR01) have no approval yet in any of the seven markets, so they show where the next competition may come from. 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 |
|---|---|---|---|---|---|---|---|---|---|
| AVT02 | Alvotech | Humira | Phase 3 | Comparative efficacy | Completed | Feb 2019 | Dec 2019 | Simlandi / Hukyndra / Libmyris | NCT03849404 |
| AVT02 | Alvotech | Humira | Phase 3 | Comparative efficacy | Completed | Jun 2020 | May 2021 | Simlandi / Hukyndra / Libmyris | NCT04453137 |
| AVT02 | Alvotech | Humira | Phase 1 | Comparative PK | Completed | Mar 2019 | Feb 2020 | Simlandi / Hukyndra / Libmyris | NCT03849313 |
| AVT02 | Alvotech | Humira | Phase 1 | Comparative PK | Completed | May 2018 | Aug 2018 | Simlandi / Hukyndra / Libmyris | NCT03579823 |
| ABP 501 | Amgen | Humira | Phase 3 | Switching | Completed | Oct 2021 | Dec 2022 | Amjevita / Amgevita | NCT05073315 |
| BCD-057 | Biocad | Humira | Phase 3 | Comparative efficacy | Completed | Dec 2016 | Dec 2017 | no approval in the seven markets | NCT02762955 |
| BCD-057 | Biocad | Humira | Phase 1 | Comparative PK | Completed | Jun 2015 | Oct 2015 | no approval in the seven markets | NCT02395055 |
| Hulio | Biocon Biologics | Humira | Phase 3 | Switching | Completed | Nov 2022 | Sep 2023 | Hulio | NCT05637515 |
| CinnoRA | CinnaGen | Humira | Phase 1 | Comparative PK | Completed | Oct 2016 | Aug 2017 | no approval in the seven markets | NCT03273192 |
| FKB327 | Fujifilm Kyowa Kirin Biologics | Humira | Phase 3 | Comparative efficacy | Completed | Jun 2015 | Jan 2018 | Hulio | NCT02405780 |
| Advixa | Incepta Pharmaceuticals | Humira | Phase 2/3 | Comparative efficacy | Unknown, last recruiting | Jun 2021 | Nov 2021 | no approval in the seven markets | NCT05172817 |
| DMB-3113 | Meiji Seika Pharma | Humira (brand not stated) | Phase 1 | Comparative PK | Completed | Aug 2016 | Jan 2017 | no approval in the seven markets | NCT02927353 |
| M923 | Momenta | Humira | Phase 3 | Comparative efficacy | Completed | Sep 2015 | Apr 2017 | no approval in the seven markets | NCT02581345 |
| Adalimumab Richmond | Richmond | Humira | Phase 1 | Comparative PK | Completed | Aug 2022 | Jan 2023 | no approval in the seven markets | NCT06291948 |
| SB5 | Samsung Bioepis | Humira | Phase 4 | Comparative PK | Completed | Aug 2022 | Apr 2023 | Hadlima / Imraldi | NCT05510063 |
| SB5 | Samsung Bioepis | Humira | Phase 3 | Comparative efficacy | Completed | May 2014 | Apr 2015 | Hadlima / Imraldi | NCT02167139 |
| GP2017 | Sandoz | Humira | Phase 3 | Comparative efficacy | Completed | Dec 2013 | Jul 2015 | Hyrimoz / Hefiya | NCT02016105 |
| HLX03 | Shanghai Henlius Biotech | Humira | Phase 1 | Comparative PK | Completed | Jan 2017 | Sep 2018 | no approval in the seven markets | NCT03357939 |
| TUR01 | Turgut | Humira | Phase 1 | Comparative PK | Completed | Jul 2019 | Jan 2020 | no approval in the seven markets | NCT04439929 |
| BMO-2 | Viatris | Humira | Phase 1 | Comparative PK | Completed | Dec 2014 | May 2015 | no approval in the seven markets | NCT02472912 |
| MYL-1401A | Viatris | Humira | Phase 3 | Comparative efficacy | Completed | Jun 2015 | May 2016 | Hulio | NCT02714322 |
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 adalimumab biosimilar in the world?
Exemptia, from Zydus in India, approved in 2014. The first in Europe and the United States came two to three years later.
Are adalimumab biosimilars interchangeable with Humira?
In the United States most of them now carry the interchangeable designation, which lets a pharmacist substitute. Europe treats all approved biosimilars as interchangeable in principle, and each country decides on substitution. India and the UAE have no such rule.
Why are there two strengths?
Humira was reformulated into a higher-concentration, citrate-free version to make injections less painful. Biosimilar makers have followed, and many now offer both the original and the high-concentration form.
Why did US biosimilars take so long to launch?
They were approved from 2016, but patent settlements with the originator set a launch date of 2023 for all of them. Approval and launch are separate events in the United States.
Which adalimumab biosimilars are available in the UAE?
Several, mostly the European products from Sandoz, Amgen, Fresenius Kabi and Biocon. The register above shows which ones.
What do regulators look at when comparing an adalimumab biosimilar?
Laboratory comparisons of structure and activity, a study of how the drug behaves in healthy volunteers, immune reactions, and usually a comparative study in psoriasis or rheumatoid arthritis.
Work with EvySaif on adalimumab
Adalimumab 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 adalimumab, 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)S006GaBI Online, Biosimilars of adalimumab SecondaryS011CDSCO, 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)
Planning adalimumab biosimilar development?
EvySaif can help assess your regulatory pathway, clinical evidence requirements and market-entry strategy across India, UAE and other target markets.
Talk to a biosimilar regulatory consultant