Abatacept biosimilars
T-cell co-stimulation modulator for rheumatoid and psoriatic arthritis and juvenile arthritis, with no biosimilar approved anywhere and one application under evaluation by EMA since June 2026.
About abatacept
Fusion protein of about 92 kDa consisting of the extracellular domain of human CTLA-4 linked to a modified Fc region of human IgG1, produced in Chinese hamster ovary cells. The Fc modifications remove complement fixation and reduce effector function.
Binds CD80 and CD86 on antigen-presenting cells and prevents them from engaging CD28 on T cells, blocking the second signal T cells need for full activation. It acts upstream of the cytokines targeted by the anti-TNF and anti-IL-6 biologics.
Intravenous or subcutaneous; half-life about 13 to 14 days, with linear pharmacokinetics at clinical doses. The subcutaneous 125 mg weekly presentation gives comparable exposure to the weight-based intravenous regimen.
Weight-based intravenous infusion (500 mg to 1 g) at weeks 0, 2 and 4, then every four weeks, from a 250 mg lyophilised vial; or 125 mg subcutaneously once weekly from pre-filled syringes and pens.
- Rheumatoid arthritis in adults
- Psoriatic arthritis
- Polyarticular juvenile idiopathic arthritis
- Prophylaxis of acute graft-versus-host disease (United States)
Anti-abatacept antibodies are uncommon and not associated with loss of efficacy. Comparative programmes would be expected to use analytical similarity, a pharmacokinetic study in healthy volunteers, and a comparative efficacy study in rheumatoid arthritis with ACR20 or DAS28 at week 24, with the subcutaneous presentation supported by a pharmacokinetic bridge.
Orencia was licensed by FDA on 23 December 2005 (BLA 125118) and authorised in the EU on 21 May 2007 (EMEA/H/C/000701), with the subcutaneous presentation added in 2011 and 2012. Bristol Myers Squibb's composition and formulation patents have limited biosimilar entry, and no biosimilar has been approved in any market in this register; one application began evaluation at EMA in June 2026.
Sources: Purple Book (S016), EMA medicines data (S017), EMA list of applications under evaluation (S019).
Abatacept is a rheumatology biologic that the first two waves of biosimilars passed over, because the fusion-protein structure is harder to match than an antibody and the market is smaller than the anti-TNFs. The EMA application of June 2026 is the first sign that a developer has cleared both hurdles. There is no Indian permission and no Gulf registration beyond the originator.
Sources: Orencia summary of product characteristics (EMA) and US prescribing information (FDA).
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 |
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 | 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 | 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 | 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 | 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 | 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 | 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.
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. Biosimilar presentations will be listed once authorised.
| Product | FDA | EMA | PMDA | HC | CDSCO | EDE |
|---|---|---|---|---|---|---|
| EU application 006741 | · | see SmPC | · | · | · | · |
Sources: Purple Book (S016), PMDA list (S020), Health Canada Drug Product Database (S022), CDSCO permission lists (S011 to S014), EDE directory (S018). EU presentations are listed in each product's SmPC.
Developers by market
| Developer | Product | FDA | EMA | 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
Questions
Is there an abatacept biosimilar approved anywhere?
No. As of September 2026 no abatacept biosimilar has been approved by FDA, EMA or CDSCO, or registered in the UAE. One application has been under evaluation by EMA since June 2026.
Who has filed an abatacept biosimilar with EMA?
EMA's monthly list gives the INN and product number (EMEA/H/C/006741) but not the applicant; the name appears only when the CHMP adopts an opinion.
Is there an abatacept biosimilar in India?
No. Abatacept does not appear in CDSCO's published r-DNA lists, for either a biosimilar or an originator import.
Why has abatacept had no biosimilars until now?
It is a fusion protein with a modified Fc region, which makes analytical matching harder than for a standard antibody, and its market is smaller than the anti-TNF products that attracted the first waves of development.
When might the first abatacept biosimilar be authorised in the EU?
A standard centralised procedure takes about a year from the start of evaluation excluding clock stops, so an application started in June 2026 could reach an opinion in 2027 if no major objections arise.
What comparative evidence will regulators expect for abatacept?
Analytical comparability including the Fc-region attributes, pharmacokinetic equivalence in healthy volunteers, and a comparative efficacy study in rheumatoid arthritis with ACR20 or DAS28 at week 24, with a pharmacokinetic bridge for the subcutaneous presentation.
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)
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