Reslizumab - Biologic Drug Details

Summary for reslizumab

Tradenames:	1
High Confidence Patents:	2
Applicants:	1
BLAs:	1
Suppliers: see list	1
Recent Clinical Trials:	See clinical trials for reslizumab

Recent Clinical Trials for reslizumab

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
TEVA	Phase 2
National Jewish Health	Phase 2
Teva Pharmaceuticals USA	Phase 2

See all reslizumab clinical trials

Pharmacology for reslizumab

Mechanism of Action	Interleukin-5 Antagonists
Established Pharmacologic Class	Interleukin-5 Antagonist

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 reslizumab Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Teva Respiratory, Llc	CINQAIR	reslizumab	Injection	761033		2017-05-02	Company disclosures
Teva Respiratory, Llc	CINQAIR	reslizumab	Injection	761033		2014-06-17	Company disclosures

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

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Teva Respiratory, Llc	CINQAIR	reslizumab	Injection	761033		2033-08-13	Patent claims search
Teva Respiratory, Llc	CINQAIR	reslizumab	Injection	761033		2032-02-15	Patent claims search
Teva Respiratory, Llc	CINQAIR	reslizumab	Injection	761033		2033-08-13	Patent claims search
Teva Respiratory, Llc	CINQAIR	reslizumab	Injection	761033		2035-06-15	Patent claims search
Teva Respiratory, Llc	CINQAIR	reslizumab	Injection	761033		2033-03-14	Patent claims search
Teva Respiratory, Llc	CINQAIR	reslizumab	Injection	761033		2035-05-29	Patent claims search

International Patents for reslizumab

Country	Patent Number	Estimated Expiration
Australia	694783
Hungary	221641
Norway	964808
Slovakia	282625
Australia	2680395
United Kingdom	9412230

Market Dynamics and Financial Trajectory for the Biologic Drug: Reslizumab

Introduction

Reslizumab, marketed as Cinqair, is a biologic drug used for the treatment of severe asthma with an eosinophilic phenotype. Here, we delve into the market dynamics and financial trajectory of this drug, highlighting its current status, market drivers, and future projections.

Market Size and Growth

The global asthma treatment market, within which reslizumab operates, was valued at USD 25.8 billion in 2021 and is anticipated to reach USD 30.1 billion by 2030, growing at a CAGR of 2.6% from 2022 to 2030[1].

Regional Analysis

North America

North America holds the largest revenue share in the asthma treatment market, accounting for over 44.3% in 2021. This region was valued at USD 15,852 million in 2021 and is expected to reach USD 16,254 million by 2030, with a CAGR of 4.05 over the forecast period[1].

Asia Pacific

While North America dominates, the Asia Pacific region is the fastest-growing market. This growth is driven by increasing healthcare expenditure, rising awareness of asthma, and a growing patient population.

Market Drivers

Increasing Prevalence of Asthma

The prevalence of asthma, particularly severe eosinophilic asthma, is a significant driver for the market. In the US, for example, 27.8 million Americans had ever been diagnosed with asthma in 2021, with a steady increase in prevalence rates over the years[1].

Advances in Biologic Therapies

Reslizumab, as an anti-IL5 monoclonal antibody, represents a significant advancement in biologic therapies for asthma. Its efficacy in reducing exacerbations and improving lung function has made it a preferred option for patients with severe eosinophilic asthma[3].

Regulatory Approvals

Reslizumab was approved by the FDA in 2016 for adults and adolescents (12 years and older) with severe asthma and elevated blood eosinophils who are inadequately controlled on inhaled corticosteroids. This approval has been a key factor in its market growth[3].

Financial Trajectory

Pricing and Cost-Effectiveness

Reslizumab is administered intravenously at a dose of 3 mg/kg every four weeks. The unit price of reslizumab is approximately $640 per vial, with the annual drug cost being less than that of mepolizumab and omalizumab in certain scenarios[2].

However, cost-utility analyses have shown mixed results. A study by the Canadian Agency for Drugs and Technologies in Health (CADTH) indicated that reslizumab would need a significant price reduction to be considered cost-effective, with an incremental cost-utility ratio (ICUR) of approximately $256,000 per quality-adjusted life-year (QALY)[2].

Revenue Projections

While specific revenue projections for reslizumab alone are not readily available, it is part of a larger market dominated by a few key players. The top 5 companies, including GSK, AstraZeneca, Sanofi-Aventis, Boehringer Ingelheim, and Teva, account for 75% of the total market share. These companies continue to focus on product development and regulatory approvals to maintain their market position[1].

Competitive Landscape

Reslizumab competes with other biologics such as mepolizumab and omalizumab. The competitive landscape is intense, with companies like AstraZeneca and GlaxoSmithKline investing heavily in research and development to maintain market share.

Comparative Efficacy

Reslizumab has been shown to be comparable in efficacy to mepolizumab and omalizumab in reducing asthma exacerbations and improving lung function. However, the cost comparison between these drugs varies based on patient weight distribution and average doses[2].

Challenges and Limitations

Cost and Accessibility

Despite its efficacy, reslizumab faces challenges related to its high cost and the need for intravenous administration, which can limit accessibility for some patients.

Clinical Data and Safety Concerns

The clinical trials for reslizumab have shown significant improvements in lung function and reductions in asthma exacerbations. However, there are limitations in the safety database, particularly regarding the detection of safety signals related to oral corticosteroid use and potential adverse reactions[3].

Future Outlook

Market Expansion

The market for biologic asthma treatments is expected to grow, driven by the increasing prevalence of asthma and the need for more effective treatments. Reslizumab, with its proven efficacy, is well-positioned to capture a significant share of this growing market.

Pipeline and Innovation

The strong pipeline of biologic drugs, including new treatments for eosinophilic esophagitis and other eosinophilic disorders, presents opportunities for reslizumab to expand its indications and patient base[4].

Key Takeaways

• Market Growth: The global asthma treatment market is expected to grow at a CAGR of 2.6% from 2022 to 2030.
• Regional Dominance: North America holds the largest revenue share, with the Asia Pacific region being the fastest-growing.
• Efficacy and Safety: Reslizumab has shown significant efficacy in reducing asthma exacerbations and improving lung function, but faces challenges related to cost and safety data.
• Competitive Landscape: Reslizumab competes with other biologics like mepolizumab and omalizumab, with a focus on cost-effectiveness and patient accessibility.
• Future Outlook: The market is expected to expand, driven by increasing prevalence and the need for effective treatments.

FAQs

What is the primary indication for reslizumab?

Reslizumab is indicated for the treatment of severe asthma with an eosinophilic phenotype in adults and adolescents (12 years and older) who are inadequately controlled on inhaled corticosteroids[3].

How is reslizumab administered?

Reslizumab is administered intravenously at a dose of 3 mg/kg every four weeks[3].

What are the key competitors to reslizumab in the market?

The key competitors to reslizumab include mepolizumab and omalizumab, which are also biologic treatments for severe asthma[2].

What are the challenges faced by reslizumab in terms of cost-effectiveness?

Reslizumab faces challenges related to its high cost, with cost-utility analyses indicating that it would need a significant price reduction to be considered cost-effective[2].

What is the expected market size of the global asthma treatment market by 2030?

The global asthma treatment market is expected to reach USD 30.1 billion by 2030[1].

Sources

1. Biospace: Asthma Treatment Market Size, Growth, Trends, Report 2022 to 2030
2. NCBI Bookshelf: EXECUTIVE SUMMARY - Reslizumab (Cinqair)
3. FDA: 761033 Reslizumab Clinical PREA
4. Business Wire: Eosinophilic Esophagitis Drug Markets, 2028 - ResearchAndMarkets.com