Pegfilgrastim-jmdb - Biologic Drug Details

Summary for pegfilgrastim-jmdb

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

Pharmacology for pegfilgrastim-jmdb

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-jmdb Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

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

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for the Biologic Drug: Pegfilgrastim-jmdb

Introduction

Pegfilgrastim-jmdb, marketed as Fulphila, is a biosimilar to the biologic drug Neulasta (pegfilgrastim), which is used to reduce the risk of infection in patients with non-myeloid cancer undergoing myelosuppressive chemotherapy. The approval and market entry of pegfilgrastim-jmdb have significantly impacted the market dynamics and financial trajectory of biologic drugs, particularly in the oncology sector.

FDA Approval and Regulatory Framework

The FDA approved Fulphila (pegfilgrastim-jmdb) in June 2018 as the first biosimilar to Neulasta, marking a significant milestone in the biosimilar market. This approval was based on extensive structural, functional, and clinical data demonstrating that Fulphila is highly similar to Neulasta with no clinically meaningful differences in safety, purity, and potency[4].

Market Entry and Competition

The entry of pegfilgrastim-jmdb into the market has introduced competition to the long-acting granulocyte colony-stimulating factor (G-CSF) segment, traditionally dominated by Neulasta. This competition has driven discounts, with pegfilgrastim-jmdb achieving discounts in the vicinity of 30% compared to the reference product[3].

Cost-Efficiency and Savings

One of the most compelling aspects of pegfilgrastim-jmdb is its cost-efficiency. Studies have shown that switching from Neulasta to pegfilgrastim-jmdb can result in substantial cost savings. For instance, a cost-efficiency analysis within the Centers for Medicare & Medicaid Services Oncology Care Model indicated that such a switch could save up to approximately $19 million for Medicare and $20 million for Medicaid patients annually. These savings can be reallocated to support other patient needs, such as food and transportation[2].

Simulation Models and Real-World Impact

Simulation models have further underscored the economic benefits of switching to pegfilgrastim-jmdb. A study involving a panel of 15,000 patients with cancer estimated cost savings ranging from $481,259 to $4,812,585 per cycle, depending on the conversion rate. Over six cycles, these savings could amount to $28,857,510, which could fund additional doses of pegfilgrastim-jmdb or other anticancer treatments[5].

Pricing Dynamics

The wholesale acquisition cost (WAC) and average sales price (ASP) of pegfilgrastim-jmdb are significantly lower than those of Neulasta. As of 2022, the WAC and ASP of pegfilgrastim-jmdb biosimilars in the U.S. were notably lower, contributing to the overall cost savings for healthcare systems[1].

Patient Access and Expanded Care

The cost savings generated by switching to pegfilgrastim-jmdb can be used to expand access to other essential healthcare services. For example, simulations suggest that these savings could provide a monthly $100 food or transportation check to thousands of Medicare and Medicaid patients for several months, thereby enhancing patient care and support[2].

Future Market Projections

The approval of pegfilgrastim-jmdb and other biosimilars is expected to continue driving down the costs of biologic drugs. With more pegfilgrastim biosimilars anticipated to enter the market, the competition is likely to increase, leading to further discounts and improved patient access to these critical medications[3].

Industry Expert Insights

Industry experts emphasize the importance of biosimilars in promoting competition and reducing drug costs. FDA Commissioner Scott Gottlieb highlighted that "bringing new biosimilars to patients is a top priority for the FDA, and a key part of our efforts to help promote competition that can reduce drug costs and promote access"[4].

Side Effects and Safety Profile

While pegfilgrastim-jmdb offers significant economic benefits, it is crucial to consider its safety profile. Common side effects include bone pain and pain in extremities, and serious side effects can include spleen rupture, acute respiratory distress syndrome, and serious allergic reactions. However, these side effects are consistent with those of the reference product, Neulasta[4].

Conclusion on Market Impact

The introduction of pegfilgrastim-jmdb has significantly altered the market dynamics for biologic drugs used in oncology. By offering a cost-effective alternative to Neulasta, pegfilgrastim-jmdb has not only reduced healthcare costs but also expanded patient access to essential treatments.

Key Takeaways

• FDA Approval: Pegfilgrastim-jmdb was approved by the FDA in 2018 as the first biosimilar to Neulasta.
• Cost Savings: Switching from Neulasta to pegfilgrastim-jmdb can result in substantial cost savings, potentially reallocated to other patient support services.
• Market Competition: The entry of pegfilgrastim-jmdb has increased competition in the G-CSF market, driving discounts and improving patient access.
• Future Projections: More biosimilars are expected to enter the market, further reducing costs and enhancing patient access.
• Safety Profile: Pegfilgrastim-jmdb has a safety profile consistent with Neulasta, with both common and serious side effects.

FAQs

Q: What is pegfilgrastim-jmdb, and how is it used?

A: Pegfilgrastim-jmdb, marketed as Fulphila, is a biosimilar to Neulasta (pegfilgrastim) used to reduce the risk of infection in patients with non-myeloid cancer undergoing myelosuppressive chemotherapy.

Q: How does pegfilgrastim-jmdb compare to Neulasta in terms of cost?

A: Pegfilgrastim-jmdb is significantly cheaper than Neulasta, offering discounts in the vicinity of 30% and lower WAC and ASP.

Q: What are the potential cost savings of switching to pegfilgrastim-jmdb?

A: Studies indicate that switching to pegfilgrastim-jmdb can save up to $19 million for Medicare and $20 million for Medicaid patients annually.

Q: How can the cost savings from pegfilgrastim-jmdb be utilized?

A: The cost savings can be reallocated to provide additional patient support services such as food and transportation assistance.

Q: What are the common and serious side effects of pegfilgrastim-jmdb?

A: Common side effects include bone pain and pain in extremities, while serious side effects can include spleen rupture, acute respiratory distress syndrome, and serious allergic reactions.

Sources

1. Statista: Wholesale acquisition cost (WAC) and average sales price (ASP) of Neulasta (pegfilgrastim) biosimilars in the United States as of 2022.
2. The Oncology Nurse: Cost-Efficiency Analysis of Switching from Reference Pegfilgrastim to Pegfilgrastim-jmdb.
3. Managed Healthcare Executive: Biologics Build Oncology Drug Pipeline.
4. FDA: FDA approves first biosimilar to Neulasta to help reduce the risk of infection during cancer treatment.
5. PubMed: Conversion from pegfilgrastim with on-body injector to pegfilgrastim-jmdb.