NEULASTA ONPRO Drug Profile

Summary for Tradename: NEULASTA ONPRO

High Confidence Patents:	0
Applicants:	1
BLAs:	1

Pharmacology for NEULASTA ONPRO

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 ONPRO Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for NEULASTA ONPRO 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 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 ONPRO 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 ONPRO	pegfilgrastim	Injection	125031	10,016,338	2033-03-11	Patent claims search
Amgen Inc.	NEULASTA ONPRO	pegfilgrastim	Injection	125031	10,016,412	2021-05-01	Patent claims search
Amgen Inc.	NEULASTA ONPRO	pegfilgrastim	Injection	125031	10,092,706	2031-04-20	Patent claims search
Amgen Inc.	NEULASTA ONPRO	pegfilgrastim	Injection	125031	10,105,389	2036-04-01	Patent claims search
Amgen Inc.	NEULASTA ONPRO	pegfilgrastim	Injection	125031	10,117,943	2039-02-26	Patent claims search

International Patents for NEULASTA ONPRO

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

Supplementary Protection Certificates for NEULASTA ONPRO

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

Market Dynamics and Financial Trajectory for Neulasta Onpro

Introduction to Neulasta Onpro

Neulasta Onpro, developed by Amgen, is a wearable injector for the biologic drug pegfilgrastim, used to reduce the incidence of infection in patients undergoing chemotherapy. This innovative delivery system has significantly impacted the market dynamics and financial performance of Amgen and the broader pegfilgrastim market.

Market Share and Competition

As of mid-2020, Neulasta Onpro held a substantial 58% share of the pegfilgrastim market[4]. Despite the entry of biosimilars, which typically reduce market share and revenue for originator products, Amgen has managed to retain a significant portion of the market. This is largely due to the convenience and unique features of the Onpro device.

Biosimilar Competition

The introduction of biosimilars has indeed affected Neulasta sales. In the second quarter of 2020, Neulasta sales decreased by 28% due to biosimilar competition[4]. However, Amgen's strategy to switch patients to the Onpro kit has helped mitigate this decline. Biosimilars, such as Coherus Biosciences' Udenyca, hold approximately 30% of the total pegfilgrastim market, but they lack a comparable delivery device to the Onpro[1].

Financial Impact

Revenue Trends

The financial performance of Neulasta Onpro reflects both the challenges and successes in the face of biosimilar competition. In 2020, despite a 28% decline in Neulasta sales due to biosimilars, Amgen's overall revenue increased by 9% to $25.4 billion, driven by higher volume growth in other products and partially offset by lower net selling prices[2].

Pricing Dynamics

The Average Selling Price (ASP) for Neulasta in the U.S. has seen a decline, with a 28% year-over-year decrease observed in recent years[2]. This pricing pressure is a result of increased competition from biosimilars. However, the unique delivery system of Onpro has allowed Amgen to maintain a premium pricing strategy to some extent.

Product Differentiation and Life Cycle Extension

Convenience and Patient Compliance

The Neulasta Onpro wearable injector offers significant convenience to patients. It enables automatic administration of pegfilgrastim the day after chemotherapy, eliminating the need for a return visit to the clinic. This feature has been particularly beneficial during the COVID-19 pandemic, where travel and clinic visits were restricted[4].

Patent Protection

While the original Neulasta patent exclusivity ended in 2015, the Onpro device remains patent protected. This protection has been crucial in maintaining Amgen's market share and discouraging the use of biosimilars, even when preferred by payers[4].

Strategic Initiatives

Switching Patients to Onpro

Amgen has actively focused on switching Neulasta patients to the Onpro kit. This strategy is part of a broader product life cycle extension plan aimed at defending against biosimilar competition. By offering a unique and convenient delivery system, Amgen has successfully retained a significant market share[4].

Future Outlook

Anticipated Trends

The biosimilars market, including the pegfilgrastim segment, is expected to see significant growth and competition. Experts anticipate that the launch of biosimilars for blockbuster biologics like Humira and Eylea will create a highly competitive market, driving down prices and increasing optionality for payers and providers[3].

Competitive Landscape

Coherus Biosciences, a key player in the biosimilars market, plans to introduce a competitor on-body injector to Neulasta Onpro in an effort to regain market share. However, the lack of a comparable delivery device currently gives Amgen a competitive edge[1].

Financial Performance Metrics

Revenue and Operating Income

For the full year 2020, Amgen's total revenues increased by 9% to $25.4 billion, despite a decline in Neulasta sales. The GAAP operating income decreased by 6% to $9.1 billion, while non-GAAP operating income increased by 11% to $12.3 billion[2].

Free Cash Flow

Amgen generated $9.9 billion in free cash flow for the full year 2020, indicating strong financial health and the ability to invest in future innovations and strategic initiatives[2].

Key Takeaways

• Market Share: Neulasta Onpro holds a significant market share in the pegfilgrastim market, driven by its unique delivery system.
• Biosimilar Competition: Despite biosimilar entry, Amgen has retained market share through product differentiation and life cycle extension strategies.
• Financial Performance: Amgen's overall revenue has been resilient, though Neulasta sales have faced pricing pressure.
• Future Outlook: The market is expected to remain competitive, with ongoing trends in biosimilar launches and pricing strategies.

FAQs

Q: What is Neulasta Onpro and how does it differ from other pegfilgrastim products?

A: Neulasta Onpro is a wearable injector for the biologic drug pegfilgrastim, offering automatic administration the day after chemotherapy, which is not available with biosimilar products.

Q: How has biosimilar competition affected Neulasta sales?

A: Biosimilar competition has led to a decline in Neulasta sales, with a 28% decrease observed in the second quarter of 2020. However, Amgen's Onpro device has helped mitigate this decline.

Q: What is the current market share of Neulasta Onpro in the pegfilgrastim market?

A: As of mid-2020, Neulasta Onpro held approximately 58% of the pegfilgrastim market.

Q: How does the patent protection of Neulasta Onpro impact the market?

A: The patent protection of the Onpro device prevents biosimilars from using a comparable delivery system, giving Amgen a competitive advantage.

Q: What are the anticipated trends in the biosimilars market for 2024?

A: The market is expected to see significant growth, increased competition, and pricing pressures, particularly for blockbuster biologics going off patent in the next 5 to 10 years.

Sources

1. Competition Squeezes Coherus' Pegfilgrastim Revenues. BiosimilarsRR, May 11, 2022.
2. Amgen Reports Fourth Quarter And Full Year 2020 Financial Results. PR Newswire, February 2, 2021.
3. Expert Discusses Anticipated Trends in Biosimilar Market for 2024. Pharmacy Times, December 21, 2023.
4. Contributor: Drug Delivery Devices Help Originator Companies Retain Market Share. Center for Biosimilars, September 19, 2020.
5. Amgen Reports Fourth Quarter And Full Year 2020 Financial Results. Amgen, February 2, 2021.