Elotuzumab - Biologic Drug Details

Summary for elotuzumab

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Suppliers: see list	1
Recent Clinical Trials:	See clinical trials for elotuzumab

Recent Clinical Trials for elotuzumab

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Washington University School of Medicine	Phase 1
Paula C. & Rodger O. Riney Blood Cancer Research	Phase 1
Pfizer	Phase 3

See all elotuzumab clinical trials

Pharmacology for elotuzumab

Mechanism of Action	SLAMF7-directed Antibody Interactions
Established Pharmacologic Class	SLAMF7-directed Immunostimulatory Antibody
Chemical Structure	Antibodies, Monoclonal

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 elotuzumab Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

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

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for the Biologic Drug: Elotuzumab

Introduction to Elotuzumab

Elotuzumab, marketed as Empliciti, is a monoclonal antibody used in the treatment of multiple myeloma, a type of blood cancer. It is co-developed by Bristol Myers Squibb and AbbVie, with Bristol Myers Squibb responsible for commercial activities.

Mechanism of Action and Clinical Use

Elotuzumab works by targeting the SLAMF7 protein on the surface of myeloma cells, leading to the activation of natural killer cells and other immune cells to attack the cancer cells. It is commonly used in combination with other therapies such as lenalidomide and dexamethasone (ELd) for patients with relapsed or refractory multiple myeloma[2][5].

Market Size and Growth

The global market for elotuzumab is projected to grow significantly over the coming years. As of 2023, the market size stood at approximately USD 1.2 billion and is anticipated to reach around USD 2.6 billion by 2032, growing at a substantial rate[4].

Market Assessment in Key Regions

The market assessment for elotuzumab is detailed across several key regions, including the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan. This comprehensive analysis includes forecasted sales data from 2025 to 2032, providing insights into the drug's market penetration and growth potential in these regions[1].

Clinical Trials and Efficacy

Elotuzumab has been evaluated in several clinical trials, including the ELOQUENT-1, ELOQUENT-2, and ELOQUENT-3 trials. While the ELOQUENT-1 trial did not show a statistically significant improvement in progression-free survival (PFS) for newly diagnosed, untreated multiple myeloma patients, the combination of elotuzumab with lenalidomide and dexamethasone remains a standard treatment for relapsed/refractory multiple myeloma[5].

Safety Profile

The safety profile of elotuzumab, particularly in combination with lenalidomide and dexamethasone, includes common adverse events such as infections, infusion reactions, and hepatotoxicity. Monitoring for these side effects is crucial to manage patient safety effectively[5].

Budget Impact Analysis

A budget impact analysis conducted for the addition of elotuzumab to health plan formularies in the United States indicated that the introduction of the ELd regimen would have a gradual and marginal budget impact. The total costs for treating relapsed/refractory multiple myeloma patients with ELd were projected to increase from $7.5 million in the first year to $21.7 million in the third year for a hypothetical health plan with 1 million members[2].

Regulatory Milestones and Development Activities

Elotuzumab has achieved several regulatory milestones, including its approval in 2015 for the treatment of patients with multiple myeloma who have received one to three prior therapies. The drug's development activities are closely monitored, with detailed descriptions of its regulatory status and other developmental activities provided in comprehensive market reports[1].

Market Competition and Emerging Therapies

The market for multiple myeloma treatments is competitive, with several emerging therapies expected to challenge elotuzumab's market position. Late-stage emerging therapies for AL amyloidosis and multiple myeloma are anticipated to significantly impact the market, providing alternative treatment options and potentially altering the market dynamics[1].

SWOT Analysis and Analyst Views

A SWOT analysis of elotuzumab highlights its strengths, such as its unique mechanism of action and established clinical efficacy in relapsed/refractory multiple myeloma. However, it also notes weaknesses, including the lack of significant benefit in newly diagnosed patients and the presence of side effects. Analyst views suggest that while elotuzumab faces competition, it remains a valuable treatment option in the multiple myeloma landscape[1].

Biologics Market Dynamics

Biologics, including elotuzumab, are a growing segment of the pharmaceutical market. Biologics now represent 42% of the total medicines market, up from 30% in 2014. The market exclusivity dynamics for biologics are shifting, with increasing exposure to biosimilar competition. This trend is expected to influence the long-term market trajectory of elotuzumab and other biologic drugs[3].

Financial Projections and Forecast

The financial projections for elotuzumab are positive, with forecasted sales expected to increase significantly over the next decade. The detailed market assessment and forecasted sales data from 2025 to 2032 will support clients in making informed decisions about their therapeutic portfolios[1][4].

Key Takeaways

• Market Growth: The global elotuzumab market is expected to grow from USD 1.2 billion in 2023 to USD 2.6 billion by 2032.
• Clinical Use: Elotuzumab is used in combination with other therapies for relapsed/refractory multiple myeloma.
• Safety Profile: Common adverse events include infections, infusion reactions, and hepatotoxicity.
• Budget Impact: The introduction of ELd has a marginal budget impact on health plans.
• Market Competition: Emerging therapies are expected to challenge elotuzumab's market position.
• Regulatory Milestones: Elotuzumab has achieved significant regulatory milestones since its approval in 2015.

FAQs

What is the primary use of elotuzumab in clinical practice?

Elotuzumab is primarily used in combination with lenalidomide and dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma.

What are the common adverse events associated with elotuzumab?

Common adverse events include infections, infusion reactions, and hepatotoxicity. Patients must be monitored for these side effects to ensure effective management.

How does the budget impact analysis for elotuzumab look?

The budget impact analysis indicates that the introduction of the ELd regimen will have a gradual and marginal budget impact on health plans, with total costs increasing from $7.5 million in the first year to $21.7 million in the third year for a hypothetical plan with 1 million members.

What is the market forecast for elotuzumab until 2032?

The global market for elotuzumab is projected to grow from USD 1.2 billion in 2023 to USD 2.6 billion by 2032.

Are there any emerging therapies that could challenge elotuzumab's market position?

Yes, several late-stage emerging therapies for AL amyloidosis and multiple myeloma are expected to challenge elotuzumab's market position and potentially alter the market dynamics.

Sources

1. Globenewswire: "Elotuzumab Emerging Drug Insight and Market Forecast 2022-2032"
2. AHDB Online: "Budget Impact Analysis of Elotuzumab in Combination with Lenalidomide and Dexamethasone for Relapsed/Refractory Multiple Myeloma"
3. FTC: "Biologics Market Dynamics: Setting the Stage for Biosimilars"
4. Dataintelo: "Elotuzumab Market Research Report 2032"
5. Bristol Myers Squibb: "Bristol Myers Squibb Reports Primary Results of ELOQUENT-1 Study Evaluating Empliciti (elotuzumab) Plus Revlimid (lenalidomide) and Dexamethasone in Patients with Newly Diagnosed, Untreated Multiple Myeloma"

Last updated: 2024-12-16