Pegfilgrastim-cbqv - Biologic Drug Details

Summary for pegfilgrastim-cbqv

Tradenames:	2
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Suppliers: see list	1

Pharmacology for pegfilgrastim-cbqv

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 pegfilgrastim-cbqv Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

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

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for Pegfilgrastim Biosimilars

Introduction to Pegfilgrastim Biosimilars

Pegfilgrastim, a biologic drug used to prevent neutropenia in patients undergoing chemotherapy, has seen a significant shift with the emergence of biosimilars. These biosimilars, such as pegfilgrastim-cbqv (Udenyca), offer a more affordable alternative to the original biologic, Neulasta.

Market Size and Growth

The global pegfilgrastim biosimilars market is projected to experience substantial growth. As of 2024, the market is 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].

Drivers of Market Growth

Patent Expiry and Regulatory Environment

The expiry of patents for major reference biologic drugs, such as Neulasta, has been a key driver. Neulasta lost its exclusivity in the U.S. in 2018, paving the way for multiple biosimilar entrants. This has led to a significant increase in the availability of affordable biosimilar versions[1].

Cost Savings and Affordability

Biosimilars offer significant cost savings, often ranging from 30-50% compared to the reference biologics. This cost reduction is a major factor in their adoption, especially in developing countries where affordability is a critical concern[1].

Increasing Cancer Cases

The rising incidence of cancer worldwide has increased the demand for supportive care therapies like pegfilgrastim. This growing patient pool, particularly in regions like Asia Pacific, drives the market forward[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 is the fastest-growing market for pegfilgrastim biosimilars. Countries like China, India, South Korea, and Japan are witnessing increased adoption due to growing cancer patient populations and significant investments in local manufacturing capabilities[1].

Market Share and Pricing Trends

As of Q3 2023, the biosimilar share of the pegfilgrastim market was 75%. The average sales price (ASP) of all pegfilgrastim products has decreased significantly, with biosimilars averaging $1,976 as of Q1 2024, down 56% from the reference product's ASP at the time of the first biosimilar launch[3].

Financial Impact and Cost Savings

Cost Savings Studies

Studies have shown that switching to biosimilar pegfilgrastim can result in substantial cost savings. For example, a study at Dana-Farber Cancer Institute estimated potential cost savings between $500,000 and $1.7 million per 100 patients treated by omitting pegfilgrastim in certain chemotherapy cycles[2].

Another study presented at ASCO estimated that over six cycles of therapy, the cost savings from using biosimilar pegfilgrastim-cbqv could be around $1,300 per patient. This translates to significant savings that could fund additional doses of chemotherapy for more patients[2].

Budget-Neutral Expanded Access

Simulation modeling has shown that converting to biosimilar pegfilgrastim can generate enough cost savings to provide budget-neutral expanded access to other chemotherapy treatments. For instance, in a panel of 2500 patients with metastatic pancreatic cancer, the savings from using biosimilar pegfilgrastim could fund 72,273 additional doses of FOLFIRINOX chemotherapy[5].

Challenges and Barriers

Regulatory and Entry Barriers

High entry barriers and stringent regulatory pathways can initially hamper the uptake of pegfilgrastim biosimilars. Incumbent competition from current biologics and potential anti-substitution laws in some countries also pose challenges[1].

Reimbursement Policies

Disparities in reimbursement policies can impact pricing and adoption scenarios, affecting the overall market growth[1].

Recent Developments and Acquisitions

Acquisition of Udenyca

In December 2024, Intas Pharmaceuticals announced an agreement to acquire the Udenyca (pegfilgrastim-cbqv) business from Coherus BioSciences. This acquisition is expected to expand Accord BioPharma's product portfolio and position the company for accelerated growth in the biosimilar industry[4].

Future Outlook

Expanding Patient Access

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

Market Penetration in Select Territories

Collaborations with regional distributors and investments in local manufacturing capabilities are expected to enhance market penetration in select territories, ensuring reliable and affordable supply to meet domestic treatment needs[1].

Key Takeaways

• The global pegfilgrastim biosimilars market is driven by patent expiry, increasing adoption of biosimilars, and rising cancer cases.
• Significant cost savings from biosimilars are a major factor in their adoption.
• North America and Asia Pacific are key regions driving market growth.
• Regulatory and entry barriers, as well as reimbursement policy disparities, pose challenges.
• Recent acquisitions and investments are expected to further expand the market.

FAQs

1. What is the current market size of the global pegfilgrastim biosimilars market?

The global pegfilgrastim biosimilars market is estimated to be valued at USD 1.69 billion in 2024[1].

2. What is the expected growth rate of the pegfilgrastim biosimilars market?

The market is expected to grow at a CAGR of 8.9% from 2024 to 2031[1].

3. What are the main drivers of the pegfilgrastim biosimilars market?

The main drivers include patent expiry of reference biologics, increasing adoption of biosimilars, and rising cancer cases worldwide[1].

4. How do biosimilars impact healthcare costs?

Biosimilars offer significant cost savings, often ranging from 30-50% compared to the reference biologics, which can lead to substantial reductions in healthcare costs[1][2].

5. Which regions are leading the adoption of pegfilgrastim biosimilars?

North America, particularly the U.S., and the Asia Pacific region are leading the adoption of pegfilgrastim biosimilars[1].

Cited Sources:

1. Coherent Market Insights: Pegfilgrastim Biosimilars Market - Price, Size, Share & Growth.
2. Healio: Bringing drug costs down a 'peg' or two.
3. Samsung Bioepis: Biosimilar Market Report.
4. PR Newswire: Accord BioPharma Announces Agreement by Intas Pharmaceuticals, Ltd. to Acquire UDENYCA® (pegfilgrastim-cbqv) Business from Coherus BioSciences, Inc.
5. PubMed: Conversion to biosimilar pegfilgrastim-cbqv enables budget-neutral expanded access to FOLFIRINOX treatment.