Pegfilgrastim-fpgk - Biologic Drug Details

Summary for pegfilgrastim-fpgk

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Suppliers: see list	1

Pharmacology for pegfilgrastim-fpgk

Physiological Effect	Increased Myeloid Cell Production
Established Pharmacologic Class	Leukocyte Growth Factor
Chemical Structure	Granulocyte Colony-Stimulating Factor Granulocyte-Macrophage 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 pegfilgrastim-fpgk Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for pegfilgrastim-fpgk Derived from Company Disclosures

No patents found based on company disclosures

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

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for Pegfilgrastim-fpgk

Introduction to Pegfilgrastim-fpgk

Pegfilgrastim-fpgk, marketed as Stimufend, is a biosimilar of the biologic drug pegfilgrastim (Neulasta), which is used to stimulate the growth of white blood cells in patients undergoing myelosuppressive chemotherapy. This biosimilar has been approved by the FDA for use in patients with non-myeloid malignancies to prevent febrile neutropenia, a common and potentially life-threatening complication of chemotherapy[2][5].

Market Share and Adoption

As of Q1 2024, the biosimilar share of the pegfilgrastim market has reached significant levels. The biosimilar share of the pegfilgrastim market was 84% as of Q1 2024, indicating a strong adoption rate. This market share has seen a notable increase, up by 9% compared to the previous quarter[1][4].

Average Sales Price (ASP) Trends

The average sales price (ASP) of pegfilgrastim products has undergone significant changes. As of Q3 2024, the average ASP of all pegfilgrastim products is $1,916, which represents a 56% decrease from the reference product's ASP at the time of the first biosimilar launch. For biosimilars alone, the average ASP is $2,175, a 53% decrease from the reference product's ASP[1][4].

Competitive Landscape

The pegfilgrastim biosimilar market is highly competitive, with multiple players vying for market share. Key players include Fulphila, Udenyca, Nyvepria, Stimufend, and Fylnetra. The market share distribution as of Q2 2024 shows Neulasta (the reference product) maintaining a significant share, while biosimilars like Fulphila and Stimufend are gaining ground. The removal of Ziextenzo from the market and ASP correction strategies by Neulasta and Fulphila have slightly increased the average ASP in 2024[1][4].

Financial Trajectory

The global pegfilgrastim biosimilars market is experiencing rapid growth. In 2023, the market size was $1.59 billion, and it is projected to grow to $1.75 billion in 2024, representing a compound annual growth rate (CAGR) of 10.0%. By 2028, the market is expected to reach $2.32 billion, with a CAGR of 7.4% during the forecast period. This growth is driven by factors such as increasing cancer prevalence, government initiatives, increased healthcare expenditure, and the low cost of biosimilars[3].

Distribution Channels and Applications

The pegfilgrastim biosimilars market is segmented by distribution channels, including hospital pharmacies, retail pharmacies, and mail-order pharmacies. In terms of applications, the primary use is in chemotherapy treatment, with other applications including transplantation and various other medical needs. The widespread distribution and multiple applications contribute to the market's robust growth[3].

Regulatory Approvals and Launches

The FDA approval of pegfilgrastim-fpgk (Stimufend) in September 2022 marked a significant milestone for Fresenius Kabi, expanding its presence in the U.S. biosimilars market. The European Commission also granted marketing authorization for Stimufend in March 2022. These approvals have facilitated the launch of the product in prefilled syringes and on-body injectors, enhancing patient access and treatment options[2][5].

Impact on Healthcare Costs

The introduction of biosimilars like pegfilgrastim-fpgk has significantly reduced healthcare costs. The average ASP of biosimilars is substantially lower than that of the reference product, leading to cost savings for patients and healthcare systems. For instance, the average ASP of trastuzumab biosimilars has dropped by 70% compared to the reference product, Herceptin[1].

Strategic Trends and Future Outlook

Several trends are shaping the future of the pegfilgrastim biosimilars market:

• Research and Development: Companies are investing heavily in R&D to develop new and improved biosimilars, taking advantage of less stringent regulations.
• Strategic Partnerships: Firms are forming strategic partnerships to expand their research and development activities and enhance their market presence.
• M&A Activities: There is an increasing focus on mergers and acquisitions to expand customer bases and geographic markets.
• Neutropenia Treatment: The production of biosimilars for neutropenia treatment is a key area of focus to improve revenues and product offerings[3].

Expert Insights

According to Michael Sen, CEO of Fresenius Kabi, "The FDA approval of our pegfilgrastim biosimilar is an important step to better support the treatment experience and clinical outcomes of cancer patients in the United States. With our portfolio, we contribute to the broader adoption of biosimilars and to a sustainable healthcare system in the U.S."[5].

Key Statistics

• Market Size: Expected to grow from $1.59 billion in 2023 to $1.75 billion in 2024 and $2.32 billion by 2028[3].
• ASP Reduction: Average ASP of pegfilgrastim products reduced by 56% compared to the reference product[1].
• Market Share: Biosimilars hold an 84% market share of the pegfilgrastim market as of Q1 2024[1].

Conclusion

The market dynamics and financial trajectory of pegfilgrastim-fpgk are characterized by strong adoption rates, competitive pricing, and significant cost savings. As the market continues to grow, driven by increasing cancer prevalence and government initiatives, biosimilars like pegfilgrastim-fpgk are poised to play a crucial role in making biologic treatments more accessible and affordable.

Key Takeaways

• Strong Market Adoption: Biosimilars have captured a significant share of the pegfilgrastim market.
• Cost Savings: Substantial reduction in ASP compared to the reference product.
• Regulatory Approvals: FDA and European Commission approvals have facilitated market entry.
• Future Growth: Projected market growth driven by increasing cancer prevalence and R&D investments.
• Competitive Landscape: Multiple players are competing for market share, driving innovation and cost efficiency.

Frequently Asked Questions (FAQs)

Q: What is pegfilgrastim-fpgk used for? A: Pegfilgrastim-fpgk (Stimufend) is used to stimulate the growth of white blood cells in patients undergoing myelosuppressive chemotherapy to prevent febrile neutropenia.

Q: Who approved pegfilgrastim-fpgk? A: The FDA approved pegfilgrastim-fpgk in September 2022, and the European Commission granted marketing authorization in March 2022.

Q: How has the market share of pegfilgrastim biosimilars evolved? A: As of Q1 2024, biosimilars hold an 84% market share of the pegfilgrastim market, indicating strong adoption.

Q: What is the average sales price (ASP) trend for pegfilgrastim biosimilars? A: The average ASP of pegfilgrastim products has decreased by 56% compared to the reference product, with biosimilars alone averaging $2,175 as of Q3 2024.

Q: What are the key drivers of the pegfilgrastim biosimilars market growth? A: The market growth is driven by increasing cancer prevalence, government initiatives, increased healthcare expenditure, and the low cost of biosimilars.

Cited Sources:

1. Samsung Bioepis. Biosimilar Market Dynamics - SAMSUNG BIOEPIS. Q3 2024.
2. Business Wire. Fresenius Kabi Receives U.S. FDA Approval for Biosimilar Stimufend® (pegfilgrastim - fpgk). September 6, 2022.
3. The Business Research Company. Global Pegfilgrastim Biosimilars Market Report 2024.
4. Samsung Bioepis. Biosimilar Market Report - SAMSUNG BIOEPIS. Q2 2024.
5. Onclive. FDA Approves Pegfilgrastim Biosimilar for Febrile Neutropenia. September 6, 2022.

Last updated: 2024-12-16