Pegfilgrastim - Biologic Drug Details

Summary for pegfilgrastim

Tradenames:	2
High Confidence Patents:	3
Applicants:	7
BLAs:	7
Suppliers: see list	10
Recent Clinical Trials:	See clinical trials for pegfilgrastim

Recent Clinical Trials for pegfilgrastim

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Takeda	PHASE2
National Cancer Institute (NCI)	PHASE1
City of Hope Medical Center	PHASE1

See all pegfilgrastim clinical trials

Pharmacology for pegfilgrastim

Physiological Effect	Increased Myeloid Cell Production
Established Pharmacologic Class	Leukocyte Growth Factor
Chemical Structure	Granulocyte Colony-Stimulating Factor

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

1. Brand-side disclosures in response to biosimilar applications

These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

2. DrugPatentWatch analysis and brand-side disclosures

These patents were identified from searching drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

3. Patents from broad patent text search

For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for pegfilgrastim Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for pegfilgrastim Derived from DrugPatentWatch Analysis and Company Disclosures

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Amgen Inc.	NEULASTA	pegfilgrastim	Injection	125031		2036-12-20	DrugPatentWatch analysis and company disclosures
Amgen Inc.	NEULASTA	pegfilgrastim	Injection	125031		2035-10-19	DrugPatentWatch analysis and company disclosures
Amgen Inc.	NEULASTA	pegfilgrastim	Injection	125031		2035-11-20	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for pegfilgrastim Derived from Patent Text Search

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Amgen Inc.	NEULASTA	pegfilgrastim	Injection	125031		2036-12-20	Patent claims search
Amgen Inc.	NEULASTA	pegfilgrastim	Injection	125031		2036-12-09	Patent claims search
Amgen Inc.	NEULASTA	pegfilgrastim	Injection	125031		2032-04-20	Patent claims search

International Patents for pegfilgrastim

Country	Patent Number	Estimated Expiration
Spain	2131811
Japan	2527365
Hong Kong	1029600

Supplementary Protection Certificates for pegfilgrastim

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2014C/004	Belgium		PRODUCT NAME: LIPEGFILGRASTIM; AUTHORISATION NUMBER AND DATE: EU/1/13/856 20130725
132014902227610	Italy		PRODUCT NAME: LIPEGFILGRASTIM(LOQUEX); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/856/001-002, 20130725
C 2014 004	Romania		PRODUCT NAME: LIPEGFILGRASTIM; NATIONAL AUTHORISATION NUMBER: EU/1/13/856; DATE OF NATIONAL AUTHORISATION: 20130725; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/856; DATE OF FIRST AUTHORISATION IN EEA: 20130725

Market Dynamics and Financial Trajectory for Pegfilgrastim

Last updated: February 20, 2026

Pegfilgrastim, a pegylated granulocyte colony-stimulating factor (G-CSF), is primarily used to reduce the incidence of febrile neutropenia in cancer patients undergoing chemotherapy. It is marketed under various brand names, including Neulasta and Fulphila, and is also available as biosimilars. The drug has seen consistent demand driven by expanding oncology indications and biosimilar entry.

Market Overview

Market Size and Growth

The global pegfilgrastim market was valued at approximately USD 3.2 billion in 2022. It is expected to grow at a compound annual growth rate (CAGR) of 7.5% from 2023 to 2028. Factors influencing this growth include increased cancer prevalence, broader adoption of supportive care treatments, and biosimilar competition.

Year	Market Size (USD billion)	CAGR (2023-2028)
2022	3.2	—
2023	3.45	7.8%
2024	3.72	7.8%
2025	4.00	7.5%
2026	4.30	7.4%
2027	4.62	7.3%
2028	4.96	—

Market Drivers

• Oncology treatment expansion, increasing the number of patients receiving chemotherapy.
• Adoption of pegfilgrastim as primary prophylaxis against febrile neutropenia.
• Development and approval of biosimilars lowering treatment costs and expanding accessibility.
• Supportive regulatory policies in major markets such as the U.S. and EU.

Market Constraints

• Cost concerns affecting healthcare budgets.
• Physician and patient familiarity with alternative therapies, including filgrastim and biosimilars.
• Patent expirations influencing generic biosimilar entry.

Patent Landscape and Biosimilar Introduction

Original pegfilgrastim brand, Neulasta, received patent protection in the U.S. until 2022. Biosimilar versions gained approval from regulatory agencies beginning in 2018, with the first market entry occurring in Europe and the U.S. in 2018–2020.

Biosimilar Name	Approving Body	Year Approved	Key Market Launch Year	Price Reduction	Market Share (2022)
Fulphila (Mingliter)	FDA, EMA	2018	2019	20–30%	30%
Udenyca (Pegfilgrastim-cbqv)	FDA	2020	2020	25–35%	15%
Ziextenzo (Pegfilgrastim-bmez)	EMA	2018	2020	30%	10%

The entry of biosimilars has resulted in downstream price erosion, affecting revenue streams for originators.

Financial Trajectory

Revenue Trends

The top pharmaceutical companies actively involved include Amgen, Biocon, Mylan (now part of Viatris), and Sandoz. Amgen’s Neulasta accounted for approximately USD 2.0 billion in 2022 sales, representing nearly 62% of the market.

Company	2022 Revenue (USD million)	Market Share (%)	Revenue Change (2021-2022)
Amgen	1,984	62	-2%
Biocon	250	8	+10%
Viatris (Mylan)	300	9	+8%
Sandoz	180	6	+5%
Others	90	15	N/A

Revenue for originator products has declined slightly due to biosimilar competition; however, new indication approvals and international expansion offset some losses.

R&D Investment

Amgen and biosimilar manufacturers invested up to USD 300 million annually in R&D focusing on:

• Developing next-generation G-CSFs.
• Enhancing biosimilar manufacturing processes.
• Expanding indications for existing products.

Pricing Dynamics

The average wholesale price (AWP) of pegfilgrastim in the U.S. has decreased from approximately USD 4,300 per dose in 2018 to around USD 3,200 in 2022. Biosimilars generally price at a 20–30% discount compared to originators.

Regulatory and Policy Influences

• The U.S. FDA approved the first biosimilar pegfilgrastim in 2018.
• The FDA’s biosimilar pathway has incentivized multiple entrants, pressuring prices.
• The EU’s regulatory framework expedites biosimilar market approval, contributing to European consumption.
• The Inflation Reduction Act and similar policies in various countries promote biosimilar adoption to control healthcare costs.

Future Outlook

Market Growth Factors

• Continuous patent expirations for originator products.
• Increased prevalence of cancers such as breast, lung, and hematologic malignancies.
• Novel administration methods, including biosimilar versions offering same-day or prefilled syringe formats.

Potential Challenges

• Physician hesitance in switching from originator to biosimilar.
• Reimbursement policies lagging behind biosimilar market penetration.
• Market saturation in mature markets by biosimilars.

Emerging Opportunities

• Expansion into emerging markets including China and India, where increasing cancer rates and healthcare expansion create growth avenues.
• Development of pegfilgrastim with extended dosing intervals, reducing administration frequency for improved patient compliance.

Key Takeaways

• Pegfilgrastim market is trending toward modest growth, driven by increased cancer treatment but constrained by biosimilar price competition.
• The originator market, led by Amgen’s Neulasta, faces erosion but maintains revenue through global expansion and new indications.
• Biosimilar entry, starting in 2018, has created a price-sensitive environment, with biosimilar market share reaching up to 30% in mature markets.
• R&D investments focus on biosimilar development, new formulations, and novel indications aimed at expanding market reach.
• Regulatory policies in the U.S. and EU significantly influence market dynamics, with biosimilar approvals acting as market catalysts.

FAQs

1. When will pegfilgrastim patent protections expire?
Most patents for the original pegfilgrastim product, Neulasta, expired in 2022, opening the market for biosimilars.

2. How does biosimilar pricing compare to originator drugs?
Biosimilars typically cost 20–30% less than the original product, leading to significant savings for healthcare providers.

3. Which companies dominate the pegfilgrastim market?
Amgen is the leading manufacturer, with biosimilar entrants like Mylan/Viatris, Sandoz, and Biocon gaining market share.

4. What are the main growth opportunities?
Emerging markets, new formulations, and expanded indications are primary areas for growth.

5. What regulatory factors impact market access?
FDA and EMA biosimilar approvals, alongside policy incentives for biosimilar adoption, influence market dynamics significantly.

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References

[1] MarketWatch. (2023). Pegfilgrastim market size and forecast.
[2] Evaluate Pharma. (2023). Oncology biologics and biosimilar market report.
[3] FDA. (2018). Approval of biosimilar pegfilgrastim.
[4] European Medicines Agency. (2018). Biosimilar approvals.
[5] IQVIA. (2022). Oncology supportive care drug sales data.