Basiliximab - Biologic Drug Details

Summary for basiliximab

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Suppliers: see list	1
Recent Clinical Trials:	See clinical trials for basiliximab
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for basiliximab

Recent Clinical Trials for basiliximab

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China	Phase 1
University Hospital, Tours	Phase 4
The First Affiliated Hospital with Nanjing Medical University	Phase 4

See all basiliximab clinical trials

Recent Litigation for basiliximab

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
Janssen Biotech, Inc. v. Amgen Inc.	2022-11-29
AbbVie Inc. v. Alvotech hf.	2021-05-28
Alvotech USA Inc. v. Abbvie Inc	2021-05-11

See all basiliximab litigation

PTAB Litigation

Petitioner	Date
	2017-12-20
	2012-09-25

See all basiliximab litigation

Pharmacology for basiliximab

Mechanism of Action	Interleukin 2 Receptor Antagonists Interleukin 2 Receptor-directed Antibody Interactions
Established Pharmacologic Class	Interleukin-2 Receptor Blocking Antibody

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 basiliximab Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for basiliximab Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for basiliximab Derived from Patent Text Search

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for Basiliximab

Introduction

Basiliximab, marketed under the brand name Simulect, is a chimeric monoclonal antibody used as an immunosuppressive agent to prevent acute rejection in kidney transplant patients. Here, we delve into the market dynamics and financial trajectory of this crucial drug.

Mechanism of Action and Clinical Use

Basiliximab functions by binding to the alpha-subunit (CD25) of the high-affinity IL-2 receptor on the surface of activated T-lymphocytes, thereby inhibiting IL-2-mediated activation of lymphocytes and reducing the risk of allograft rejection[5].

Economic Benefits in Renal Transplantation

Studies have shown that basiliximab offers significant economic benefits in renal transplantation. For instance, a study conducted in 21 renal transplant centers across seven countries found that basiliximab resulted in an estimated economic saving of $4,554 during the first year after transplant, primarily due to reduced costs associated with graft dysfunction, graft loss, and follow-up hospitalizations[1].

Cost Comparison with Other Immunoprophylaxis

When compared to antithymocyte globulin (ATG), another immunoprophylaxis agent, basiliximab demonstrated lower first-year post-treatment costs. A clinical trial in the US showed that the first-year costs for patients receiving basiliximab were $45,857, compared to $54,729 for those receiving ATG, resulting in a savings of $8,872[2].

Market Status in China

In China, basiliximab is widely used in kidney transplantation, with the market expected to grow significantly from 2019 to 2023. The incidence of chronic kidney disease in China is high, with over 3 million patients suffering from end-stage renal disease. This has driven the demand for basiliximab, with the drug being used in conjunction with other immunosuppressive therapies based on cyclosporine and corticosteroids[4].

Sales and Market Share

The sales of basiliximab in China have been substantial, with the only approved product being Simulect by Novartis. The sales value and volume of basiliximab in China have shown steady growth, with Novartis holding a significant market share. The retail prices of Simulect vary across different regions in China, but the overall trend indicates a stable and growing market[4].

Clinical and Economic Impact in Liver Transplantation

While basiliximab is primarily used in kidney transplantation, its use in liver transplantation has also been evaluated. However, a study on the clinical and economic impact of changing the protocol for basiliximab use in orthotopic liver transplantation found that universal use of the first dose of basiliximab did not yield the expected benefits and instead resulted in increased costs. This suggests that the use of basiliximab in liver transplantation may need to be more targeted and based on patient risk factors[3].

Forecast and Market Trends

The market for basiliximab is expected to maintain a high growth rate from 2019 to 2023, driven by several factors:

• Increasing Incidence of Chronic Kidney Disease: The growing prevalence of chronic kidney disease, particularly in countries like China, is a significant driver.
• Expanding Applications: Potential applications in fields such as liver transplantation could further boost demand.
• Generic Drugs: The anticipated launch of generic versions of basiliximab by domestic enterprises in China is likely to increase market competition and accessibility[4].

Retail Prices and Cost Analysis

The cost of basiliximab, while significant, is offset by the economic savings it provides through reduced hospitalization and treatment costs. For example, the cost of a course of basiliximab (two doses of 20 mg) is approximately $3,000, but this results in a net first-year saving of $1,554 when considering the overall cost of care[1].

Conclusion

Basiliximab has established itself as a crucial and economically viable immunosuppressive agent in renal transplantation. Its market dynamics are characterized by significant economic benefits, lower costs compared to other immunoprophylaxis agents, and a growing market driven by increasing demand and potential new applications.

Key Takeaways

• Economic Savings: Basiliximab offers substantial economic savings in renal transplantation through reduced hospitalization and treatment costs.
• Market Growth: The market for basiliximab is expected to grow significantly, particularly in regions with high incidence rates of chronic kidney disease.
• Clinical Use: Basiliximab is primarily used in kidney transplantation but is being evaluated for use in other types of organ transplants.
• Cost Analysis: Despite the initial cost, basiliximab results in net savings over the first year post-transplant.
• Market Trends: The market is driven by increasing demand, potential new applications, and the anticipated launch of generic versions.

FAQs

Q: What is the primary use of basiliximab in medical treatment? A: Basiliximab is primarily used as an immunosuppressive agent to prevent acute rejection in kidney transplant patients.

Q: How does basiliximab compare economically to other immunoprophylaxis agents like ATG? A: Basiliximab has been shown to have lower first-year post-treatment costs compared to ATG, resulting in significant economic savings.

Q: What are the key drivers of the basiliximab market in China? A: The key drivers include the high incidence of chronic kidney disease, increasing urbanization, and the anticipated launch of generic versions of the drug.

Q: Is basiliximab used in other types of organ transplants besides kidney transplants? A: Yes, basiliximab is being evaluated for use in other types of organ transplants, such as liver transplantation, although its use in these areas is still under scrutiny.

Q: What is the expected market growth for basiliximab from 2019 to 2023? A: The market for basiliximab is expected to maintain a high growth rate from 2019 to 2023, driven by increasing demand and potential new applications.

Sources

1. Economic analysis of basiliximab in renal transplantation - PubMed
2. An economic and quality‐of‐life assessment of basiliximab vs antithymocyte globulin immunoprophylaxis in renal transplantation - Nephrology Dialysis Transplantation
3. Clinical-economic impact of the change of protocol for use of basiliximab in orthohepatic transplant - Elsevier
4. Investigation Report on China's Basiliximab Market, 2019-2023 - ResearchAndMarkets.com
5. Basiliximab: Uses, Interactions, Mechanism of Action - DrugBank