Omalizumab biosimilars
An antibody for severe allergic asthma, chronic hives and nasal polyps, with one biosimilar in the West and one in India.
About omalizumab
Omalizumab is an antibody that mops up IgE, the antibody the body makes in allergic reactions. With IgE out of circulation, the cells that release histamine stay quiet, and asthma attacks and hives become less frequent.
It binds IgE in the blood before the IgE can attach to mast cells. Over time the mast cells also carry fewer IgE receptors. It does not touch IgE already on cells, so it does not itself trigger a reaction.
An injection under the skin every two or four weeks. The dose depends on the patient's weight and IgE level, which is why the product comes in several strengths.
Severe allergic asthma, chronic spontaneous urticaria, chronic rhinosinusitis with nasal polyps and, in the United States, IgE-mediated food allergy.
A biosimilar is compared in the laboratory, in healthy volunteers by measuring how far it lowers free IgE, and in a clinical study in chronic hives, where itch scores can be compared within three months. Regulators extend the result to asthma and nasal polyps.
The reference product is Xolair, from Roche and Novartis. It has been on the market for two decades, and its dosing table by weight and IgE level is one of the more complicated parts of copying it.
Omalizumab is the immunology molecule with the most open markets: one biosimilar in the United States and Europe, one in India, none in the Gulf. The clinical study is small and the blood marker is easy to measure, so it is a practical choice for a company entering biosimilars now.
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
- Todaythree omalizumab biosimilars are approved in at least one of the seven markets.
- With regulators nowEU application 006687, EU application 006756 are under review. A decision usually comes within a year.
- Further outBP11, Generium omalizumab, Genolair are still at the pharmacokinetic stage, usually two to three years from any approval.
- If all of them arriveThe approved count would rise from three to eight. The applications under review are anonymous in the EMA list and are probably some of the same candidates, so six 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 |
|---|---|---|---|---|---|---|---|
| FDA | Omlyclo | CELLTRION, Inc. | Mar 2025 | 761399 | Interchangeable | Approved | S001, S016 |
| EMA | Omlyclo | Celltrion Healthcare Hungary Kft. | May 2024 | EMEA/H/C/005958 | Approved | S017 | |
| EMA | Application 006756 | Applicant not yet named by EMA | since Oct 2025 | EMEA/H/C/006756 | Under review | S019 | |
| EMA | Application 006687 | Applicant not yet named by EMA | since Feb 2026 | EMEA/H/C/006687 | Under review | S019 | |
| MHRA | Omlyclo | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Adcomfo | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| PMDA | Omalizumab BS CT | Celltrion Healthcare Japan | Mar 2026 | not published | Approved | S020 | |
| HC | Omlyclo | Celltrion INC. | Dec 2024 | DIN 02553805, 02553813, 02561018, 02561026 | Approved | S022 | |
| CDSCO | Reliance Life Sciences (INN only) | Reliance Life Sciences Pvt Ltd | Feb 2020 | MF/BIO/20/000009 | 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 omalizumab 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 omalizumab programmes. Regulatory strategy consulting
Presentations and concentration
Solution presentations are 75 mg in 0.5 mL and 150 mg in 1 mL (150 mg/mL) pre-filled syringes and pens, with a 300 mg/2 mL pen for the reference product. Some markets also have 75 mg and 150 mg lyophilised vials.
| Product | FDA | EMA | MHRA | PMDA | HC | CDSCO | EDE |
|---|---|---|---|---|---|---|---|
| Omlyclo CT-P39 | 75 mg/0.5 mL, 150 mg/mL PFS; 300 mg/2 mL | see SmPC | 75 mg, 150 mg and 300 mg syringes and pens | 75 mg and 150 mg syringes and pens | 150, 75 mg | · | · |
| Reliance Life Sciences omalizumab | · | · | · | · | · | 150 mg lyophilised powder for injection | · |
| EU application 006756 | · | see SmPC | · | · | · | · | · |
| EU application 006687 | · | see SmPC | · | · | · | · | · |
| Adcomfo | · | · | 75 mg and 150 mg syringes | · | · | · | · |
EU presentations are listed in each product's SmPC.
Developers by market
| Developer | Product | FDA | EMA | MHRA | PMDA | HC | CDSCO | EDE |
|---|---|---|---|---|---|---|---|---|
| Celltrion | Omlyclo | ✓ | ✓ | ✓ | ✓ | ✓ | · | · |
| Reliance Life Sciences | Reliance Life Sciences omalizumab | · | · | · | · | · | ✓ | · |
| Applicant not yet named by EMA | EU application 006756 | · | review | · | · | · | · | · |
| Applicant not yet named by EMA | EU application 006687 | · | review | · | · | · | · | · |
| Not stated in the MHRA list | Adcomfo | · | · | ✓ | · | · | · | · |
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
Omlyclo
Reliance Life Sciences omalizumab
EU application 006756
EU application 006687
Adcomfo
In development
ClinicalTrials.gov holds three comparative trials of three omalizumab biosimilar candidates against the reference product, run by two sponsors. None of the candidates (BP11, Generium omalizumab, Genolair) 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 |
|---|---|---|---|---|---|---|---|---|---|
| Generium omalizumab | Generium | Xolair | Phase 1 | Comparative PK | Completed | Apr 2017 | Sep 2017 | no approval in the seven markets | NCT04601389 |
| Genolair | Generium | Xolair | Phase 1 | Comparative PK | Completed | Jan 2023 | Jun 2024 | no approval in the seven markets | NCT06494345 |
| BP11 | Syneos Health (CRO sponsor) | Xolair | Phase 1 | Comparative PK | Completed | Feb 2022 | Jan 2024 | no approval in the seven markets | NCT05053334 |
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 omalizumab biosimilar?
Reliance's product in India in 2020. In Europe and the United States, Celltrion's Omlyclo, approved in 2024 and 2025 and interchangeable from the start in the United States.
Is there an omalizumab biosimilar in the UAE?
Not yet. Xolair is registered.
How is an omalizumab biosimilar tested?
Laboratory comparison, a volunteer study measuring how far the drug lowers free IgE, and a clinical comparison in chronic hives.
Does the biosimilar cover food allergy?
In the United States the label follows the reference product at the time of approval. Omlyclo's US label states which uses it carries.
Why is the dosing complicated?
The dose is set from the patient's weight and IgE level, so the product must come in several strengths and the label must reproduce the originator's dosing table exactly.
Are omalizumab biosimilars interchangeable in the United States?
Yes. Omlyclo was designated interchangeable on the day of its approval.
Work with EvySaif on omalizumab
Omalizumab 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 omalizumab, 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)S011CDSCO, new drugs (r-DNA origin) approved for manufacture and marketing, Jan 2020 to June 2026 (CT-21) Primary (regulator)S019EMA, applications for new human medicines under evaluation by the CHMP, August 2026 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)S018UAE Emirates Drug Establishment, registered medical product directory Primary (regulator)S013CDSCO, import and market permissions till 2019 (r-DNA) 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 omalizumab 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