NEULASTA Drug Profile

Summary for Tradename: NEULASTA

High Confidence Patents:	3
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
Sutro Biopharma, Inc.	Phase 2
Australasian Gastro-Intestinal Trials Group	Phase 2
Walter and Eliza Hall Institute of Medical Research	Phase 2

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. General 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 NEULASTA Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for NEULASTA Derived from 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	5,580,755	2013-12-03	Company disclosures
Amgen Inc.	NEULASTA	pegfilgrastim	Injection	125031	5,582,823	2013-12-10	Company disclosures
Amgen Inc.	NEULASTA	pegfilgrastim	Injection	125031	5,824,784	2039-02-26	Company disclosures
Amgen Inc.	NEULASTA ONPRO	pegfilgrastim	Injection	125031	5,580,755	2013-12-03	Company disclosures
Amgen Inc.	NEULASTA ONPRO	pegfilgrastim	Injection	125031	5,582,823	2013-12-10	Company disclosures
Amgen Inc.	NEULASTA ONPRO	pegfilgrastim	Injection	125031	5,824,784	2039-02-26	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	10,016,338	2033-03-11	Patent claims search
Amgen Inc.	NEULASTA	pegfilgrastim	Injection	125031	10,016,412	2021-05-01	Patent claims search
Amgen Inc.	NEULASTA	pegfilgrastim	Injection	125031	10,092,706	2031-04-20	Patent claims search
Amgen Inc.	NEULASTA	pegfilgrastim	Injection	125031	10,105,389	2036-04-01	Patent claims search
Amgen Inc.	NEULASTA	pegfilgrastim	Injection	125031	10,117,943	2039-02-26	Patent claims search
Amgen Inc.	NEULASTA	pegfilgrastim	Injection	125031	10,195,188	2036-06-13	Patent claims search

International Patents for NEULASTA

Country	Patent Number	Estimated Expiration
Denmark	175551
European Patent Office	2392594
European Patent Office	2399930
Japan	3115561
Luxembourg	91006
New Zealand	217334

Supplementary Protection Certificates for NEULASTA

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
6/2003	Austria		PRODUCT NAME: PEGFILGRASTIM; REGISTRATION NO/DATE: EU/1/02/227/001 20020822
122014000005	Germany		PRODUCT NAME: LIPEGFILGRASTIM; REGISTRATION NO/DATE: EU/1/13/856/001-002 20130725
2014/006	Ireland		PRODUCT NAME: LONQUEX-LIPEGFILGRASTIM; REGISTRATION NO/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
300637	Netherlands		PRODUCT NAME: LIPEGFILGRASTIM; REGISTRATION NO/DATE: EU/1/13/856 20130729
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

Introduction

Neulasta, a pioneering pegfilgrastim therapy developed by Amgen, has been a cornerstone in the treatment of neutropenia, a common side effect of chemotherapy. However, the market dynamics for Neulasta have undergone significant changes in recent years, driven by the emergence of biosimilars, patent expirations, and evolving healthcare policies.

Market Growth and Drivers

The global pegfilgrastim biosimilars market, which includes Neulasta and its biosimilar counterparts, is projected to grow substantially. By 2024, this market is estimated to be valued at USD 1.69 billion and is expected to reach USD 3.07 billion by 2031, with a compound annual growth rate (CAGR) of 8.9% from 2024 to 2031[1].

Increasing Demand for Biosimilars

The rising demand for cheaper biosimilar alternatives to reference biologic drugs is a key driver of market growth. Patients and healthcare systems are increasingly opting for biosimilars due to significant cost savings without compromising on quality or efficacy[1].

Patent Expiry and Regulatory Environment

The expiry of patents for major reference biologic drugs, including Neulasta, has paved the way for the commercialization of biosimilars. Neulasta lost its exclusivity in the U.S. in 2018, allowing multiple biosimilar entrants into the market. Regulatory incentives in regions like Europe and Asia Pacific further drive the adoption of biosimilars[1].

Financial Impact of Biosimilar Competition

The introduction of biosimilars has had a profound impact on Neulasta's financial performance. In the fourth quarter of 2022, Neulasta sales decreased by 37% year-over-year, and by 35% for the full year, primarily due to biosimilar competition[2].

Sales Decline and Market Share

Despite the decline in sales, Amgen has managed to retain a significant market share through innovative drug delivery systems. The Neulasta Onpro, a wearable injector launched in 2015, has been particularly successful. By mid-2020, the Onpro held a 58% share of the pegfilgrastim market, highlighting the importance of convenient and patient-friendly delivery systems in maintaining market share[4].

Competitive Landscape

The competitive landscape for Neulasta is increasingly complex, with multiple biosimilar entrants and evolving market strategies.

High Entry Barriers

High entry barriers and stringent regulatory pathways can initially hamper the uptake of biosimilars. However, once these barriers are overcome, biosimilars can significantly disrupt the market[1].

Incumbent Competition

Incumbent competition from current biologics, including Neulasta, poses challenges for new biosimilar entrants. However, the cost savings and regulatory support for biosimilars are gradually shifting market dynamics in favor of these alternatives[1].

Regional Market Dynamics

North America

North America, particularly the U.S., dominates the global pegfilgrastim biosimilars market with an estimated market share of 41.3% in 2024. Favorable reimbursement policies and the presence of large regional pharmaceutical companies contribute to this dominance[1].

Asia Pacific

The Asia Pacific region has emerged as the fastest-growing market for pegfilgrastim biosimilars. Countries like China, India, South Korea, and Japan are witnessing increased adoption due to growing cancer patient pools and significant investments in local manufacturing capabilities. China's "Made in China 2025" program further supports the development of a strong biosimilars industry[1].

Financial Performance of Amgen

Revenue and Net Income

Amgen's financial reports reflect the impact of biosimilar competition on Neulasta sales. In 2022, total revenues for Amgen remained relatively stable, but the decline in Neulasta sales was evident. The company's GAAP net income decreased by 15% in the fourth quarter of 2022 compared to the previous year[2].

Operating Expenses and Margins

Amgen's operating expenses and margins have been affected by the increased competition. The company has seen a decline in operating income and net income, which is partly offset by the success of other products and the Neulasta Onpro delivery system[2].

Future Outlook

Expanding Patient Access

Cost reductions and expanding patient access remain priority areas. Emerging markets like China and India are expected to adopt biosimilars faster, contributing to global revenue growth. Investments in novel drug delivery systems and collaborations with regional distributors will aid market penetration[1].

Regulatory and Reimbursement Policies

Regulatory and reimbursement policies will continue to play a crucial role in shaping the market. Disparities in these policies can impact pricing and adoption scenarios, but overall, they are expected to support the growth of biosimilars[1].

Key Takeaways from Analysts

Analysts highlight that the growth of the pegfilgrastim biosimilars market is driven by the patent expiry of blockbuster drugs like Neulasta and the increasing adoption of biosimilars by physicians and payers. Regulatory incentives and cost savings are key factors driving this growth[1].

Conclusion

The market dynamics for Neulasta are characterized by intense competition from biosimilars, driven by patent expiries and regulatory support. While Amgen has retained a significant market share through innovative delivery systems, the financial trajectory for Neulasta reflects the challenges posed by biosimilar competition.

Key Takeaways

• Market Growth: The pegfilgrastim biosimilars market is expected to grow significantly, driven by cost savings and regulatory support.
• Biosimilar Competition: Neulasta sales have declined due to biosimilar competition, but innovative delivery systems like the Neulasta Onpro have helped retain market share.
• Regional Dynamics: North America and Asia Pacific are key regions, with the latter showing rapid growth due to increasing cancer patient pools and government support.
• Financial Performance: Amgen's financials reflect the impact of biosimilar competition, with a decline in Neulasta sales but stable overall revenues.
• Future Outlook: Expanding patient access, investments in drug delivery systems, and regulatory support will continue to shape the market.

FAQs

What is the projected market value of the pegfilgrastim biosimilars market by 2031?

The pegfilgrastim biosimilars market is expected to reach USD 3.07 billion by 2031[1].

How has the patent expiry of Neulasta affected the market?

The patent expiry of Neulasta in 2018 allowed multiple biosimilar entrants into the market, significantly impacting Neulasta's sales and market share[1].

What role do drug delivery systems play in retaining market share?

Innovative drug delivery systems like the Neulasta Onpro have helped Amgen retain a significant market share by offering convenience and patient-friendly solutions[4].

Which regions are driving the growth of the pegfilgrastim biosimilars market?

North America and the Asia Pacific region are key drivers of market growth, with the latter showing rapid expansion due to growing cancer patient pools and government support[1].

How do regulatory policies impact the adoption of biosimilars?

Regulatory policies, particularly in regions like Europe and Asia Pacific, incentivize the uptake of biosimilars, driving market growth and adoption[1].

Sources

1. Coherent Market Insights - Pegfilgrastim Biosimilars Market - Price, Size, Share & Growth
2. Amgen - AMGEN REPORTS FOURTH QUARTER AND FULL YEAR 2022 FINANCIAL RESULTS
3. ASPE - Economic Analysis of Availability of Follow-on Protein Products
4. Center for Biosimilars - Contributor: Drug Delivery Devices Help Originator Companies Retain Market Share
5. Coherus BioSciences - Coherus BioSciences Reports Fourth Quarter and Full Year 2021 Results