Pegfilgrastim biosimilars
A long-acting version of a white blood cell booster, given once per chemotherapy cycle, with eight US biosimilars and six Indian makers.
About pegfilgrastim
Pegfilgrastim is filgrastim, a protein that boosts white blood cells, attached to a chemical tail that keeps it in the body far longer. One injection replaces a week or more of daily filgrastim after chemotherapy.
Chemotherapy kills the white blood cells that fight infection. Pegfilgrastim tells the bone marrow to make more, faster. The tail slows its removal from the body, and as white cells recover they clear the drug themselves, so it switches off naturally.
One injection under the skin the day after each chemotherapy cycle, from a pre-filled syringe. One US biosimilar also comes as a small device stuck to the skin that injects automatically.
Prevention of infection and fever caused by low white cell counts in people having chemotherapy.
A biosimilar is compared in the laboratory, especially the way the chemical tail is attached, and in healthy volunteers by counting white blood cells after a dose. Earlier products also ran a comparison in patients on chemotherapy; recent approvals have not needed it.
The reference product is Neulasta, from Amgen. Its patents expired years before the first biosimilar arrived, because the attached tail proved harder to copy than expected and several early applications failed.
Pegfilgrastim looks simple but proved hard to copy, because of the chemical tail attached to the protein. It is now one of the most competitive US markets, with eight products and new entrants from Lupin and Accord in 2025 and 2026. Six Indian companies make it, and Biocon supplies the United States, Europe and the Gulf from Bengaluru.
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
- Todayeighteen pegfilgrastim biosimilars are approved in at least one of the seven markets.
- With regulators nowNylaspeg is under review. A decision usually comes within a year.
- Nearest to marketEurofarma pegfilgrastim has reached phase 3, the last trial before a filing.
- If all of them arriveThe approved count would rise from eighteen to twenty. The applications under review are anonymous in the EMA list and are probably some of the same candidates, so nineteen 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 | Fulphila | Biocon Biologics Inc. | Jun 2018 | 761075 | Biosimilar | Approved | S001, S016 |
| FDA | Udenyca | Accord BioPharma Inc. | Nov 2018 | 761039 | Biosimilar | Approved | S001, S016 |
| FDA | Ziextenzo | Sandoz Inc. | Nov 2019 | 761045 | Biosimilar | Approved | S001, S016 |
| FDA | Nyvepria | Hospira Inc., a Pfizer Company | Jun 2020 | 761111 | Biosimilar | Approved | S001, S016 |
| FDA | Fylnetra | Kashiv BioSciences, LLC | May 2022 | 761084 | Biosimilar | Approved | S001, S016 |
| FDA | Stimufend | Fresenius Kabi USA, LLC | Sep 2022 | 761173 | Biosimilar | Approved | S001, S016 |
| FDA | Armlupeg | Lupin Limited (Biotech Division) | Nov 2025 | 761212 | Biosimilar | Approved | S001, S016 |
| FDA | Ennumo | Accord BioPharma Inc. | May 2026 | 761147 | Biosimilar | Approved | S001, S016 |
| EMA | Pelgraz | Accord Healthcare S.L.U. | Sep 2018 | EMEA/H/C/003961 | Approved | S017 | |
| EMA | Udenyca | ERA Consulting GmbH | Sep 2018 | EMEA/H/C/004413 | Withdrawn | S017 | |
| EMA | Fulphila | Biosimilar Collaborations Ireland Limited | Nov 2018 | EMEA/H/C/004915 | Approved | S017 | |
| EMA | Pelmeg | Mundipharma Corporation (Ireland) Limited | Nov 2018 | EMEA/H/C/004700 | Approved | S017 | |
| EMA | Ziextenzo | Sandoz GmbH | Nov 2018 | EMEA/H/C/004802 | Approved | S017 | |
| EMA | Grasustek | Juta Pharma GmbH | Jun 2019 | EMEA/H/C/004556 | Approved | S017 | |
| EMA | Cegfila | Mundipharma Corporation (Ireland) Limited | Dec 2019 | EMEA/H/C/005312 | Approved | S017 | |
| EMA | Nyvepria | Pfizer Europe MA EEIG | Nov 2020 | EMEA/H/C/005085 | Approved | S017 | |
| EMA | Stimufend | Fresenius Kabi Deutschland GmbH | Mar 2022 | EMEA/H/C/004780 | Approved | S017 | |
| EMA | Dyrupeg | CuraTeQ Biologics (Malta) Limited | Mar 2025 | EMEA/H/C/006407 | Approved | S017 | |
| EMA | Vivlipeg | Biosimilar Collaborations Ireland Limited | Aug 2025 | EMEA/H/C/006739 | Approved | S017 | |
| EMA | Nylaspeg | Qilu Pharma Spain S.L. | opinion Jun 2026 | EMEA/H/C/006085 | Under review | S017 | |
| EMA | Cavoley | CuraTeQ Biologics s.r.o | opinion Jul 2026 | EMEA/H/C/006937 | Under review | S017 | |
| MHRA | Dyrupeg | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Fulphila | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Grasustek | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Pelgraz | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Pelmeg | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Ziextenzo | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| PMDA | Pegfilgrastim BS Mochida / Nipro | Mochida Pharmaceutical; Mochida Pharmaceutical Sales | Sep 2023 | not published | Approved | S020 | |
| HC | Lapelga | Apotex INC | Apr 2018 | DIN 02474565, 02529343 | Approved | S022 | |
| HC | Fulphila | Biocon Biologics Canada INC | Dec 2018 | DIN 02484153 | Approved | S022 | |
| HC | Ziextenzo | Sandoz Canada Incorporated | Apr 2020 | DIN 02497395 | Approved | S022 | |
| HC | Nyvepria | Pfizer Canada ULC | Oct 2020 | DIN 02506238 | Approved | S022 | |
| HC | Niopeg | Nora Pharma INC | Apr 2024 | DIN 02546973 | Approved | S022 | |
| CDSCO | Gennova Biopharmaceuticals (INN only) | Gennova Biopharmaceuticals Ltd | Jan 2010 | MF-104/10 | Approved | S014 | |
| CDSCO | Dr. Reddy's Laboratories (INN only) | Dr. Reddy's Laboratories Ltd | Jan 2011 | MF-05/2011 | Approved | S014 | |
| CDSCO | Lupin (INN only) | Lupin Limited | Sep 2013 | MF-186/2013 | Approved | S014 | |
| CDSCO | Wockhardt (INN only) | Wockhardt Limited | Feb 2015 | MF-41/2015 | Approved | S014 | |
| CDSCO | USV Private (INN only) | USV Private Limited | Sep 2019 | MF/BIO/19/000044 | Approved | S014 | |
| CDSCO | Virchow Biotech (INN only) | Virchow Biotech Pvt Ltd | Dec 2021 | MF/BIO/21/000140 | Approved | S011 | |
| EDE | Biopegfil | Biocon Biologics Limited, India | Feb 2019 | not published | Registered | S018 | |
| EDE | Fulphila | Biocon Biologics Limited, India (country of origin Ireland) | Nov 2019 | not published | Registered | S018 | |
| EDE | Ziextenzo | Novartis Pharmaceutical Manufacturing GmbH (Sandoz) | Oct 2020 | not published | Registered | S018 | |
| EDE | Pelgraz | Accord Healthcare Limited, United Kingdom | Dec 2021 | not published | Registered | S018 | |
| EDE | Nyvepria | Hospira Zagreb d.o.o. (Pfizer) | May 2024 | 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 pegfilgrastim 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 pegfilgrastim programmes. Regulatory strategy consulting
Presentations and concentration
All biosimilar presentations are 6 mg in 0.6 mL (10 mg/mL) pre-filled syringes. Udenyca Onbody is an on-body injector version of the same dose.
| Product | FDA | EMA | MHRA | PMDA | HC | CDSCO | EDE |
|---|---|---|---|---|---|---|---|
| Fulphila / Vivlipeg / Biopegfil MYL-1401H | 6 mg/0.6 mL PFS | see SmPC | 6 mg syringe | · | 10 mg | · | 6 mg/0.6 mL |
| Udenyca CHS-1701 | 6 mg/0.6 mL PFS; on-body injector (Udenyca Onbody, December 2023) | see SmPC | · | · | · | · | · |
| Ziextenzo LA-EP2006 | 6 mg/0.6 mL PFS | see SmPC | 6 mg syringe | · | 6 mg | · | 6 mg/0.6 mL |
| Nyvepria PF-06881894 | 6 mg/0.6 mL PFS | see SmPC | · | · | 6 mg | · | 6 mg/0.6 mL |
| Fylnetra | 6 mg/0.6 mL PFS | · | · | · | · | · | · |
| Stimufend MSB11455 | 6 mg/0.6 mL PFS | see SmPC | · | · | · | · | · |
| Armlupeg / Lupin pegfilgrastim | 6 mg/0.6 mL PFS | · | · | · | · | 6 mg/0.6 mL PFS | · |
| Pelgraz / Ennumo | 6 mg/0.6 mL PFS | see SmPC | 6 mg syringe and pre-filled injector | · | 6 mg | · | 6 mg/0.6 mL |
| Pelmeg / Cegfila B12019 | · | see SmPC | 6 mg syringe | · | · | · | · |
| Grasustek | · | see SmPC | 6 mg syringe | · | · | · | · |
| Dyrupeg / Cavoley | · | see SmPC | 6 mg syringe | · | · | · | · |
| Nylaspeg | · | see SmPC | · | · | · | · | · |
| Gennova pegfilgrastim | · | · | · | · | · | 6 mg/0.6 mL PFS | · |
| Dr. Reddy's pegfilgrastim | · | · | · | · | · | 6 mg/0.6 mL PFS | · |
| Wockhardt pegfilgrastim | · | · | · | · | · | 6 mg/0.6 mL PFS and vial | · |
| USV pegfilgrastim | · | · | · | · | · | 6 mg/0.6 mL PFS | · |
| Virchow Biotech pegfilgrastim | · | · | · | · | · | 6 mg/0.6 mL PFS | · |
| Pegfilgrastim BS Mochida / Nipro | · | · | · | 3.6 mg subcutaneous injection | · | · | · |
| Niopeg | · | · | · | · | 6 mg | · | · |
EU presentations are listed in each product's SmPC.
Developers by market
| Developer | Product | FDA | EMA | MHRA | PMDA | HC | CDSCO | EDE |
|---|---|---|---|---|---|---|---|---|
| Biocon Biologics (with Mylan / Viatris) | Fulphila / Vivlipeg / Biopegfil | ✓ | ✓ | ✓ | · | ✓ | · | ✓ |
| Coherus BioSciences | Udenyca | ✓ | withdrawn | · | · | · | · | · |
| Sandoz | Ziextenzo | ✓ | ✓ | ✓ | · | ✓ | · | ✓ |
| Pfizer (Hospira) | Nyvepria | ✓ | ✓ | · | · | ✓ | · | ✓ |
| Kashiv BioSciences | Fylnetra | ✓ | · | · | · | · | · | · |
| Fresenius Kabi | Stimufend | ✓ | ✓ | · | · | · | · | · |
| Lupin | Armlupeg / Lupin pegfilgrastim | ✓ | · | · | · | · | ✓ | · |
| Intas Pharmaceuticals | Pelgraz / Ennumo | ✓ | ✓ | ✓ | · | ✓ | · | ✓ |
| Cinfa Biotech | Pelmeg / Cegfila | · | ✓ | ✓ | · | · | · | · |
| Juta Pharma | Grasustek | · | ✓ | ✓ | · | · | · | · |
| CuraTeQ Biologics (Aurobindo) | Dyrupeg / Cavoley | · | ✓ | ✓ | · | · | · | · |
| Qilu Pharmaceutical | Nylaspeg | · | review | · | · | · | · | · |
| Gennova Biopharmaceuticals (Emcure) | Gennova pegfilgrastim | · | · | · | · | · | ✓ | · |
| Dr. Reddy's Laboratories | Dr. Reddy's pegfilgrastim | · | · | · | · | · | ✓ | · |
| Wockhardt | Wockhardt pegfilgrastim | · | · | · | · | · | ✓ | · |
| USV | USV pegfilgrastim | · | · | · | · | · | ✓ | · |
| Virchow Biotech | Virchow Biotech pegfilgrastim | · | · | · | · | · | ✓ | · |
| Mochida Pharmaceutical | Pegfilgrastim BS Mochida / Nipro | · | · | · | ✓ | · | · | · |
| Nora Pharma | Niopeg | · | · | · | · | ✓ | · | · |
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
Fulphila / Vivlipeg / Biopegfil
Udenyca
Ziextenzo
Nyvepria
Fylnetra
Stimufend
Armlupeg / Lupin pegfilgrastim
Pelgraz / Ennumo
Pelmeg / Cegfila
Grasustek
Dyrupeg / Cavoley
Nylaspeg
Gennova pegfilgrastim
Dr. Reddy's pegfilgrastim
Wockhardt pegfilgrastim
USV pegfilgrastim
Virchow Biotech pegfilgrastim
Pegfilgrastim BS Mochida / Nipro
Niopeg
In development
ClinicalTrials.gov holds eight comparative trials of six pegfilgrastim biosimilar candidates against the reference product, run by six sponsors. One of the candidates (Eurofarma pegfilgrastim) 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 |
|---|---|---|---|---|---|---|---|---|---|
| B12019 | Cinfa Biotech | Neulasta | Phase 1 | Comparative PK | Completed | Nov 2015 | Jul 2016 | Pelmeg / Cegfila | NCT02629562 |
| B12019 | Cinfa Biotech | Neulasta | Phase 1 | Comparative PK | Completed | Sep 2016 | May 2017 | Pelmeg / Cegfila | NCT02912377 |
| Eurofarma pegfilgrastim | Eurofarma | Neulastim | Phase 3 | Comparative efficacy | Withdrawn | Jan 2018 | Oct 2019 | no approval in the seven markets | NCT02768714 |
| INTP5 | Intas Pharmaceuticals | Neulasta | Phase 1 | Comparative PK | Completed | Feb 2018 | May 2018 | Pelgraz / Ennumo | NCT04014062 |
| INTP5 | Intas Pharmaceuticals | Neulasta | Phase 1 | Comparative PK | Completed | Feb 2018 | Jun 2018 | Pelgraz / Ennumo | NCT04015232 |
| PF-06881894 | Pfizer | Neulasta | Phase 1 | Comparative PK | Completed | Oct 2017 | Jul 2018 | Nyvepria | NCT03273842 |
| QL0605 | Qilu Pharmaceutical | Neulasta | Phase 1 | Comparative PK | Unknown, last recruiting | Nov 2020 | Nov 2021 | Nylaspeg | NCT04651036 |
| LA-EP2006 | Sandoz | Neulasta | Phase 3 | Comparative efficacy | Completed | Jun 2012 | May 2013 | Ziextenzo | NCT01735175 |
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 pegfilgrastim biosimilar?
Gennova's product in India in 2010, followed by Dr. Reddy's in 2011. Europe and the United States approved their first in 2018.
Why did US biosimilars take so long?
The attached chemical tail proved hard to match, and several early applications were rejected on laboratory grounds before the first approval in 2018.
Is there a biosimilar with the on-body injector?
Yes. Udenyca Onbody, approved in 2023, is the first biosimilar with a device that sticks to the skin and injects automatically.
Which pegfilgrastim biosimilars are registered in the UAE?
Five, from Biocon, Sandoz, Accord and Pfizer, alongside Neulasta.
Are pegfilgrastim biosimilars interchangeable in the United States?
No. None of the eight carries the designation.
How is a pegfilgrastim biosimilar tested?
Laboratory comparison of the protein and its chemical tail, and a study in healthy volunteers counting white blood cells after a dose.
Work with EvySaif on pegfilgrastim
Pegfilgrastim 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 pegfilgrastim, 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)S011CDSCO, 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)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 pegfilgrastim biosimilar development?
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