Filgrastim biosimilars
A white blood cell booster given daily after chemotherapy, the molecule behind the first biosimilar in the United States and the first growth factor biosimilars in Europe.
About filgrastim
Filgrastim is a copy of the natural protein that tells the bone marrow to make white blood cells. It is given daily to people whose counts have fallen after chemotherapy, and to donors before stem cells are collected.
White blood cells fight infection, and chemotherapy destroys them. Filgrastim stimulates the marrow to produce and release more, shortening the time a patient is at risk. It also moves stem cells into the blood, where they can be collected for transplant.
A daily injection under the skin, or sometimes into a vein, from pre-filled syringes or vials, until the white cell count recovers.
Low white cell counts after chemotherapy or bone marrow transplant, collection of stem cells, and rare conditions where the body makes too few white cells.
Filgrastim is a small, simple protein and was among the first to be copied. A biosimilar is compared in the laboratory and in healthy volunteers by counting white blood cells. Regulators no longer expect a clinical trial in patients.
The reference product is Neupogen, from Amgen. It was approved in 1991, before Europe's central approval system existed, so it has no European product number, though all its biosimilars do.
Biosimilars began with filgrastim. Europe approved its first growth factor biosimilars in 2008, and Zarxio, a filgrastim, was the first biosimilar of any kind approved in the United States in 2015. The market is mature, prices are low, and manufacturing scale matters more than clinical work. India has had products since the early 2000s.
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
- Todaytwelve filgrastim biosimilars are approved in at least one of the seven markets.
- With regulators nowEU application 007009 is under review. A decision usually comes within a year.
- Further outLeucostim is still at the pharmacokinetic stage, usually two to three years from any approval.
- If all of them arriveThe approved count would rise from twelve to fourteen. The applications under review are anonymous in the EMA list and are probably some of the same candidates, so thirteen is the more realistic figure.
1 published switching studies with filgrastim biosimilars, 1 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 | Zarxio | Sandoz Inc. | Mar 2015 | 125553 | Biosimilar | Approved | S001, S016 |
| FDA | Nivestym | Hospira Inc., a Pfizer Company | Jul 2018 | 761080 | Biosimilar | Approved | S001, S016 |
| FDA | Releuko | Kashiv BioSciences, LLC | Feb 2022 | 761082 | Biosimilar | Approved | S001, S016 |
| FDA | Nypozi | Tanvex BioPharma USA, Inc. | Jun 2024 | 761126 | Biosimilar | Approved | S001, S016 |
| FDA | Filkri | Accord BioPharma Inc. | Jan 2026 | 761027 | Biosimilar | Approved | S001, S016 |
| EMA | Tevagrastim | Teva GmbH | Sep 2008 | EMEA/H/C/000827 | Approved | S017 | |
| EMA | Ratiograstim | Ratiopharm GmbH | Sep 2008 | EMEA/H/C/000825 | Approved | S017 | |
| EMA | Biograstim | AbZ-Pharma GmbH | Sep 2008 | EMEA/H/C/000826 | Withdrawn | S017 | |
| EMA | Filgrastim ratiopharm | Ratiopharm GmbH | Sep 2008 | EMEA/H/C/000824 | Withdrawn | S017 | |
| EMA | Zarzio | Sandoz GmbH | Feb 2009 | EMEA/H/C/000917 | Approved | S017 | |
| EMA | Filgrastim Hexal | Hexal AG | Feb 2009 | EMEA/H/C/000918 | Approved | S017 | |
| EMA | Nivestim | Pfizer Europe MA EEIG | Jun 2010 | EMEA/H/C/001142 | Approved | S017 | |
| EMA | Grastofil | Accord Healthcare S.L.U. | Oct 2013 | EMEA/H/C/002150 | Withdrawn | S017 | |
| EMA | Accofil | Accord Healthcare S.L.U. | Sep 2014 | EMEA/H/C/003956 | Approved | S017 | |
| EMA | Zefylti | CuraTeQ Biologics (Malta) Limited | Feb 2025 | EMEA/H/C/006400 | Approved | S017 | |
| EMA | Application 007009 | Applicant not yet named by EMA | since Jul 2026 | EMEA/H/C/007009 | Under review | S019 | |
| MHRA | Accofil | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Nivestim | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Zarzio | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Zefylti | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| PMDA | Filgrastim BS F / Mochida | Fuji Pharma; Mochida Pharmaceutical | Nov 2012 | not published | Approved | S020 | |
| PMDA | Filgrastim BS NK | Nippon Kayaku | Feb 2013 | not published | Approved | S020 | |
| PMDA | Filgrastim BS Sandoz | Sandoz K.K. | Mar 2014 | not published | Approved | S020 | |
| HC | Grastofil | Apotex INC | Dec 2015 | DIN 02441489, 02454548 | Approved | S022 | |
| HC | Nivestym | Pfizer Canada ULC | Apr 2020 | DIN 02485575, 02485583, 02485591, 02485656 | Approved | S022 | |
| HC | Nypozi | Tanvex Biopharma Usa, INC. | Oct 2021 | DIN 02520990, 02521008 | Approved | S022 | |
| CDSCO | Gennova Biopharmaceuticals (INN only) | Gennova Biopharmaceuticals Ltd | Mar 2010 | MF-229/10 | Approved | S014 | |
| CDSCO | Lupin (INN only) | Lupin Limited | Mar 2013 | MF-22/2013 | Approved | S014 | |
| CDSCO | Cadila Pharmaceuticals (INN only) | Cadila Pharmaceuticals Limited | Oct 2013 | MF-135/2013 | Approved | S014 | |
| EDE | Zarzio | Novartis Pharmaceutical Manufacturing GmbH (Sandoz) | Mar 2015 | not published | Registered | S018 | |
| EDE | TevaGrastim | Teva Pharmaceutical Industries, Israel | Jun 2022 | 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 a filgrastim 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 filgrastim programmes. Regulatory strategy consulting
Presentations and concentration
300 micrograms in 0.5 mL and 480 micrograms in 0.8 mL pre-filled syringes (600 micrograms/mL), or 300 micrograms/mL vials. EU products are labelled in million units: 30 MU is 300 micrograms.
| Product | FDA | EMA | MHRA | PMDA | HC | CDSCO | EDE |
|---|---|---|---|---|---|---|---|
| Zarxio / Zarzio EP2006 | 300 mcg/0.5 mL, 480 mcg/0.8 mL PFS; 300 mcg/mL vials | see SmPC | 30 and 48 MU syringes | 75, 150 and 300 microgram syringes | · | · | 30 MU/0.5 mL, 48 MU/0.5 mL |
| Tevagrastim / Ratiograstim XM02 | · | see SmPC | · | · | · | · | 30 MIU/0.5 mL, 48 MIU/0.8 mL |
| Nivestym / Nivestim PF-06881893 | 300 mcg/0.5 mL, 480 mcg/0.8 mL PFS; 300 mcg/mL vials | see SmPC | 12, 30 and 48 MU | · | 300, 480 micrograms | · | · |
| Releuko | 300 mcg/0.5 mL, 480 mcg/0.8 mL PFS; 300 mcg/mL vials | · | · | · | · | · | · |
| Nypozi TX01 | 300 mcg/0.5 mL, 480 mcg/0.8 mL PFS | · | · | · | 300, 480 micrograms | · | · |
| Accofil / Filkri | 300 mcg/0.5 mL, 480 mcg/0.8 mL PFS | see SmPC | 12, 30, 48 and 70 MU syringes | · | 300, 480 micrograms | · | · |
| Zefylti | · | see SmPC | 30 and 48 MU syringes | · | · | · | · |
| Gennova filgrastim | · | · | · | · | · | PFS and vial | · |
| Lupin filgrastim | · | · | · | · | · | 300 mcg/0.5 mL PFS; 60 MIU/mL vial | · |
| Cadila Pharmaceuticals filgrastim | · | · | · | · | · | 300 mcg/mL PFS | · |
| EU application 007009 | · | see SmPC | · | · | · | · | · |
| Filgrastim BS F / Mochida | · | · | · | 75, 150 and 300 microgram syringes | · | · | · |
| Filgrastim BS NK | · | · | · | 75, 150 and 300 microgram syringes | · | · | · |
EU presentations are listed in each product's SmPC.
Developers by market
| Developer | Product | FDA | EMA | MHRA | PMDA | HC | CDSCO | EDE |
|---|---|---|---|---|---|---|---|---|
| Sandoz | Zarxio / Zarzio | ✓ | ✓ | ✓ | ✓ | · | · | ✓ |
| Teva (with Ratiopharm) | Tevagrastim / Ratiograstim | · | ✓ | · | · | · | · | ✓ |
| Pfizer (Hospira) | Nivestym / Nivestim | ✓ | ✓ | ✓ | · | ✓ | · | · |
| Kashiv BioSciences | Releuko | ✓ | · | · | · | · | · | · |
| Tanvex BioPharma | Nypozi | ✓ | · | · | · | ✓ | · | · |
| Intas Pharmaceuticals (Apotex) | Accofil / Filkri | ✓ | ✓ | ✓ | · | ✓ | · | · |
| CuraTeQ Biologics (Aurobindo) | Zefylti | · | ✓ | ✓ | · | · | · | · |
| Gennova Biopharmaceuticals (Emcure) | Gennova filgrastim | · | · | · | · | · | ✓ | · |
| Lupin | Lupin filgrastim | · | · | · | · | · | ✓ | · |
| Cadila Pharmaceuticals | Cadila Pharmaceuticals filgrastim | · | · | · | · | · | ✓ | · |
| Applicant not yet named by EMA | EU application 007009 | · | review | · | · | · | · | · |
| Fuji Pharma (with Mochida) | Filgrastim BS F / Mochida | · | · | · | ✓ | · | · | · |
| Nippon Kayaku | Filgrastim BS NK | · | · | · | ✓ | · | · | · |
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
Zarxio / Zarzio
Tevagrastim / Ratiograstim
Nivestym / Nivestim
Releuko
Nypozi
Accofil / Filkri
Zefylti
Gennova filgrastim
Lupin filgrastim
Cadila Pharmaceuticals filgrastim
EU application 007009
Filgrastim BS F / Mochida
Filgrastim BS NK
In development
ClinicalTrials.gov holds two comparative trials of two filgrastim biosimilar candidates against the reference product, run by two sponsors. One of the candidates (Leucostim) has 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 |
|---|---|---|---|---|---|---|---|---|---|
| Leucostim | Biocad | Neupogen | Phase 1 | Comparative PK | Completed | Jul 2016 | Nov 2016 | no approval in the seven markets | NCT02762799 |
| Filgrastim Hospira | Pfizer | Neupogen | Phase 1 | Comparative PK | Completed | Oct 2016 | Jan 2017 | Nivestym / Nivestim | NCT02923791 |
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 biosimilar in the United States?
Zarxio, Sandoz's filgrastim, in March 2015.
Why does Neupogen have no European product number?
It was approved in each European country separately in 1991, before the central approval system covered it. Its biosimilars were all approved centrally.
Is there an Indian filgrastim biosimilar?
Many. Intas launched the first in 2004, before the published lists begin, and Gennova, Lupin and Cadila hold manufacturing permissions, with several import permissions besides.
Which filgrastim biosimilars are registered in the UAE?
Sandoz's Zarzio and Teva's product, alongside Neupogen.
How is a filgrastim biosimilar tested?
Laboratory comparison and a study in healthy volunteers counting white blood cells. A clinical trial in patients is no longer required.
Are filgrastim biosimilars interchangeable in the United States?
No. None of the five carries the designation.
Work with EvySaif on filgrastim
Filgrastim 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 filgrastim, 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)S018UAE Emirates Drug Establishment, registered medical product directory 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)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 filgrastim biosimilar development?
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