Abatacept biosimilars
A protein that calms T cells, used in rheumatoid and psoriatic arthritis, with no biosimilar approved anywhere and one application under review in Europe.
About abatacept
Abatacept is a fusion protein that interrupts the signal T cells need before they become active. It acts earlier in the immune chain than the anti-TNF and anti-interleukin drugs.
T cells need two signals to switch on. Abatacept blocks the second one, so the immune response that damages joints in rheumatoid arthritis is dampened at its source.
Either an infusion into a vein every four weeks or an injection under the skin every week.
Rheumatoid arthritis, psoriatic arthritis and childhood arthritis.
No biosimilar has been assessed yet. A programme is likely to compare the product in the laboratory, in healthy volunteers, and in a clinical study in rheumatoid arthritis.
The reference product is Orencia, from Bristol Myers Squibb. Its patents have kept biosimilars away for longer than most rheumatology biologics.
Abatacept has had no biosimilars so far, because a fusion protein is harder to match than an antibody and the market is smaller than the anti-TNFs. The European application of 2026 is the first to be filed.
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
- TodayNo abatacept biosimilar is approved yet in any of the seven markets.
- With regulators nowEU application 006741 is under review. A decision usually comes within a year.
- Further outDRL_AB, M834 are still at the pharmacokinetic stage, usually two to three years from any approval.
- If all of them arriveThe approved count would rise from zero to three. The applications under review are anonymous in the EMA list and are probably some of the same candidates, so two 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 |
|---|---|---|---|---|---|---|---|
| EMA | Application 006741 | Applicant not yet named by EMA | since Jun 2026 | EMEA/H/C/006741 | Under review | S019 |
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 PMDA's list and the UAE directory do not publish application numbers; Canadian dates are the first approval or market date recorded in the Drug Product Database.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 abatacept 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 abatacept programmes. Regulatory strategy consulting
Presentations and concentration
Reference presentations are a 250 mg lyophilised vial for infusion and 125 mg in 1 mL subcutaneous syringes and pens. No biosimilar presentation has been authorised yet.
| Product | FDA | EMA | MHRA | PMDA | HC | CDSCO | EDE |
|---|---|---|---|---|---|---|---|
| EU application 006741 | · | see SmPC | · | · | · | · | · |
EU presentations are listed in each product's SmPC.
Developers by market
| Developer | Product | FDA | EMA | MHRA | PMDA | HC | CDSCO | EDE |
|---|---|---|---|---|---|---|---|---|
| Applicant not yet named by EMA | EU application 006741 | · | 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
In development
ClinicalTrials.gov holds two comparative trials of two abatacept biosimilar candidates against the reference product, run by two sponsors. None of the candidates (DRL_AB, M834) 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 |
|---|---|---|---|---|---|---|---|---|---|
| DRL_AB | Dr. Reddy's Laboratories | Orencia | Phase 1 | Comparative PK | Unknown, last recruiting | Oct 2023 | Apr 2024 | no approval in the seven markets | NCT06126042 |
| M834 | Momenta | Orencia | Phase 1 | Comparative PK | Completed | Oct 2016 | Jul 2017 | no approval in the seven markets | NCT02923583 |
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 an abatacept biosimilar approved anywhere?
No. One application has been under review in Europe since 2026.
Who has filed an abatacept biosimilar in Europe?
EMA publishes the molecule and product number but not the applicant until the committee gives its opinion.
Is there an abatacept biosimilar in India?
No. Abatacept does not appear in the Indian permission lists at all.
Why has abatacept had no biosimilars until now?
It is a fusion protein with a modified tail, harder to copy than an antibody, and its market is smaller than the anti-TNF drugs that came first.
When might the first abatacept biosimilar be approved?
A European review takes about a year if no major questions arise, so an opinion in 2027 is possible.
How would an abatacept biosimilar be tested?
Laboratory comparison, a volunteer study and a clinical comparison in rheumatoid arthritis, with a further volunteer study for the under-the-skin form.
Work with EvySaif on abatacept
Abatacept 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 abatacept, with the gaps ranked and a filing sequence recommended.
About the gap assessmentSources
S019EMA, applications for new human medicines under evaluation by the CHMP, August 2026 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)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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