NEULASTA Drug Profile

Summary for Tradename: NEULASTA

High Confidence Patents:	22
Applicants:	1
BLAs:	1
Drug Prices:	Drug price information for NEULASTA
Recent Clinical Trials:	See clinical trials for NEULASTA

See drug prices for NEULASTA

Recent Clinical Trials for NEULASTA

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Kexing Biopharm Co., Ltd.	PHASE3
PharmaEssentia	PHASE1
Novotech CRO	PHASE1

See all NEULASTA clinical trials

Pharmacology for NEULASTA

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 company disclosures

These patents were identified from searching various sources, including 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 NEULASTA Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for NEULASTA 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
Amgen Inc.	NEULASTA	pegfilgrastim	Injection	125031		2035-04-01	DrugPatentWatch analysis and company disclosures
Amgen Inc.	NEULASTA	pegfilgrastim	Injection	125031		2034-03-14	DrugPatentWatch analysis and company disclosures
Amgen Inc.	NEULASTA	pegfilgrastim	Injection	125031		1994-10-25	DrugPatentWatch analysis and company disclosures
Amgen Inc.	NEULASTA	pegfilgrastim	Injection	125031		1996-05-26	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for NEULASTA 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
Amgen Inc.	NEULASTA	pegfilgrastim	Injection	125031		2037-03-31	Patent claims search
Amgen Inc.	NEULASTA	pegfilgrastim	Injection	125031		2033-05-03	Patent claims search
Amgen Inc.	NEULASTA	pegfilgrastim	Injection	125031		2037-09-01	Patent claims search
Amgen Inc.	NEULASTA	pegfilgrastim	Injection	125031		2032-03-29	Patent claims search

International Patents for NEULASTA

Country	Patent Number	Estimated Expiration
Greece	3030526
Australia	2019200353
Japan	2004041242
Mexico	2011013417
Israel	134754
Norway	2003008
Japan	6453841

Supplementary Protection Certificates for NEULASTA

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
10299044	Germany		PRODUCT NAME: PEGFILGRASTIM; REGISTRATION NO/DATE: EU/1/02/227/001 20020822
300106	Netherlands		PRODUCT NAME: PEGFILGRASTIM; REGISTRATION NO/DATE: EU/1/02/228/001 20020822
C300106	Netherlands		PRODUCT NAME: PEGFILGRASTIM; NAT. REGISTRATION NO/DATE: EU/1/02/228/001 20020822; FIRST REGISTRATION: EU/1/02/228/001 20020822
SZ 5/2003	Austria		PRODUCT NAME: PEGFILGRASTIM
300637	Netherlands		PRODUCT NAME: LIPEGFILGRASTIM; REGISTRATION NO/DATE: EU/1/13/856 20130729
5/2003	Austria		PRODUCT NAME: PEGFILGRASTIM; REGISTRATION NO/DATE: EU/1/02/228/001 20020822
SPC/GB03/006	United Kingdom		PRODUCT NAME: PEGFILGRASTIM, AN N-TERMINALLY MONOPEGYLATED G-CSF (GRANULOCYTE COLONY STIMULATING FACTOR); REGISTERED: UK EU/1/02/228/001 20020826; UK EU/1/02/227/001 20020826

Market Dynamics and Financial Trajectory for the Biologic Drug: NEULASTA

Last updated: September 19, 2025

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Introduction

Neulasta (pegfilgrastim), a long-acting granulocyte colony-stimulating factor (G-CSF), has cemented its role in oncology supportive care by reducing the incidence of febrile neutropenia (FN) in patients undergoing chemotherapy. Since its approval in 2002, Neulasta’s market presence has been shaped by evolving clinical guidelines, competitive pressures, regulatory dynamics, and the broader landscape of biologics. This analysis examines the current market drivers influencing Neulasta, assesses its financial trajectory, and explores strategic implications for stakeholders.

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Market Dynamics Surrounding NEULASTA

1. Clinical and Therapeutic Landscape

Neulasta’s therapeutic niche hinges on preventing neutropenic complications, a common and serious chemotherapy-induced toxicity ([1]). Its efficacy, convenience of a single injection per chemotherapy cycle, and established safety profile have made it the standard of care in many settings. However, the rise of biosimilars, notably pegfilgrastim biosimilars introduced since 2018, has intensified price competition and impacted Neulasta’s market share ([2]).

2. Regulatory Environment and Patent Expiry

Originally patented by Amgen, Neulasta’s patent protection expired in numerous markets during the late 2010s, paving the way for biosimilar entrants ([3]). The U.S. FDA approved the first pegfilgrastim biosimilar in 2018, leading to price erosion and increased market penetration by competitors such as Sandoz’s Ziextenzo and Coherus’s Udenyca. Regulatory pathways for biosimilar approval have streamlined, further encouraging biosimilar development and commercialization.

3. Pricing and Reimbursement Dynamics

Neulasta enjoyed premium pricing driven by brand recognition and clinical preference. However, biosimilars have introduced downward pressure on prices, especially in highly competitive markets like the U.S. and Europe. Payer policies increasingly favor biosimilars to control costs; in some instances, full switches from Neulasta to biosimilars are incentivized ([4]). Consequently, revenue erosion due to price competition has affected physicians’ and institutions’ prescribing behaviors.

4. Market Penetration and Adoption Trends

While initially dominant, Neulasta’s market share has declined from over 80% prior to biosimilar entry in the U.S., to approximately 30-40% in recent years ([5]). The adoption rate of biosimilars varies geographically, influenced by local regulatory policies, physician acceptance, and reimbursement models. Notably, some healthcare systems favor biosimilars for economic reasons, while others remain cautious due to concerns over interchangeability and clinical equivalence.

5. Future Competitiveness and Innovation

Amgen and competitors are investing in next-generation G-CSF products, including fixed-dose combinations and novel formulations aimed at improving patient compliance and reducing administration costs. Additionally, the utilization of subcutaneous versus biosimilar formulations continues to influence market dynamics. The emergence of precision medicine and personalized oncology may further tailor supportive care, influencing the demand for agents like Neulasta.

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Financial Trajectory of NEULASTA

1. Revenue Trends

Neulasta’s global revenues peaked in the early 2010s, exceeding $3 billion annually ([6]). Post-biosimilar entry, revenue declined significantly in key markets. For instance, Amgen reported a substantial decrease in U.S. sales since 2018, aligning with biosimilar approvals and adoption ([7]). Despite this, Neulasta remains a lucrative product due to its entrenched clinical utility and international sales in markets with slower biosimilar uptake.

2. Impact of Biosimilars on Profitability

Biosimilar competition has led to sharp price reductions, sometimes exceeding 40-60% compared to the Neulasta premium price ([8]). This has pressured profit margins, prompting Amgen and others to pursue innovative strategies such as formulary negotiations, patient assistance programs, and value-based contracts to preserve revenue streams.

3. Revenue Diversification and Portfolio Strategy

Amgen’s strategic response includes increasing focus on its portfolio of biologics, such as Blincyto and Xgeva, and expanding into biosimilar markets beyond pegfilgrastim. The company emphasizes pipeline development, including next-generation G-CSF drugs that may command premium pricing if they demonstrate clinical superiority, thus potentially offsetting biosimilar competition.

4. Long-Term Outlook

Given ongoing biosimilar penetration, revenues from Neulasta are projected to continue declining unless differentiated versions or novel indications are approved. However, international markets, particularly in emerging economies, maintain higher prices and extensive use of Neulasta, offering some revenue stability. Additionally, the potential for new formulations or delivery methods could rejuvenate interest.

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Strategic Implications for Stakeholders

• Pharmaceutical Companies: Investing in biosimilar development and marketing is essential to capture cost-conscious healthcare systems. Innovation in drug delivery and indications can restore competitive advantages.
• Health Care Providers and Payers: Emphasize evidence-based prescribing and adopt biosimilars to optimize treatment costs. Education on biosimilarity and clinical equivalence is crucial to mitigate resistance.
• Regulatory Bodies: Streamline pathways for biosimilar approval and implement policies that encourage interchangeability, ensuring market access and affordability.
• Investors: Focus on companies balancing biosimilar portfolios and pipeline innovation, as traditional blockbuster revenues decline.

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Key Takeaways

• Market penetration by biosimilars has significantly eroded Neulasta’s market share and revenue, especially in mature markets like the U.S. and Europe.
• Pricing pressures and payer policies increasingly favor biosimilars, compelling Amgen and competitors to adapt strategically.
• International markets remain vital, with higher pricing and slower biosimilar adoption providing revenue buffers.
• Innovative formulations and indications represent future growth avenues to counteract biosimilar competition.
• Stakeholders should prioritize cost-effective, evidence-based utilization and foster innovations to sustain profitability and patient access.

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FAQs

1. How has the entry of biosimilars impacted Neulasta’s market share globally?
Biosimilar entry has sharply reduced Neulasta’s market share, particularly in the U.S. and Europe, with biosimilars capturing an estimated 60-70% of the pegfilgrastim market within a few years of approval.

2. What strategic moves has Amgen made to maintain Neulasta’s competitiveness?
Amgen has focused on cost management, expanding indications, developing next-generation formulations, and engaging in global markets where biosimilar penetration is less advanced.

3. Are biosimilars considered interchangeable with Neulasta in clinical practice?
Regulatory agencies like the FDA have approved biosimilars as highly similar, but interchangeability varies by jurisdiction. Many clinicians view biosimilars as therapeutically equivalent, but acceptance depends on local policies and clinician confidence.

4. What are the future growth prospects for Neulasta?
Growth prospects are limited in mature markets due to biosimilar competition but remain viable in emerging economies. Innovations in drug delivery or new indications could offer additional growth paths.

5. How should investors approach the biologics space considering Neulasta’s trajectory?
Investors should diversify across innovative biologics, biosimilar pipelines, and emerging markets, recognizing the declining revenue trend of traditional blockbusters like Neulasta in developed markets.

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References

1. Smith TJ, et al. (2018). "Guidelines for the Use of Granulocyte Colony-Stimulating Factors." Journal of Oncology Practice.
2. Amgen. (2021). “Neulasta (pegfilgrastim) Product Information.”
3. U.S. FDA. (2018). “Approval of First Biosimilar for Pegfilgrastim.”
4. IMS Health Data. (2022). “Biosimilar Adoption Trends in Oncology.”
5. EvaluatePharma. (2022). “Global Oncology Biologics Market Overview.”
6. Amgen Financial Reports. (2010–2022).
7. Amgen. (2022). “Q2 and Full-Year 2022 Financial Results.”
8. IQVIA. (2022). “Biosimilar Market Dynamics and Price Trends.”

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