KEVZARA Drug Profile

Summary for Tradename: KEVZARA

High Confidence Patents:	0
Applicants:	1
BLAs:	1
Drug Prices:	Drug price information for KEVZARA
Recent Clinical Trials:	See clinical trials for KEVZARA

See drug prices for KEVZARA

Recent Clinical Trials for KEVZARA

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
M.D. Anderson Cancer Center	Phase 1
Regeneron Pharmaceuticals	Phase 1
Fort Worth Clinical Sciences Working Group	Phase 2

See all KEVZARA clinical trials

Pharmacology for KEVZARA

Mechanism of Action	Interleukin 6 Receptor Antagonists
Established Pharmacologic Class	Interleukin-6 Receptor 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 KEVZARA Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

3) Low Certainty: US Patents for KEVZARA 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
Sanofi-aventis U.s. Llc	KEVZARA	sarilumab	Injection	761037		2032-02-15	Patent claims search
Sanofi-aventis U.s. Llc	KEVZARA	sarilumab	Injection	761037		2033-10-31	Patent claims search
Sanofi-aventis U.s. Llc	KEVZARA	sarilumab	Injection	761037		2033-03-14	Patent claims search
Sanofi-aventis U.s. Llc	KEVZARA	sarilumab	Injection	761037		2038-05-08	Patent claims search

Market Dynamics and Financial Trajectory for the Biologic Drug: Kevzara

Introduction

Kevzara, developed by Sanofi and Regeneron, is an interleukin-6 receptor antibody used in the treatment of rheumatoid arthritis (RA). Since its approval, the drug has navigated a complex and competitive market landscape. Here, we delve into the market dynamics and financial trajectory of Kevzara.

Market Entry and Competition

Kevzara was approved by the FDA in May 2017, marking Sanofi and Regeneron’s second major entry into the immunology field, following the approval of Dupixent for severe eczema[4].

Competitive Landscape

The RA market is highly competitive, with well-established TNF-alpha inhibitors such as Humira, and other IL-6 drugs like Roche’s Actemra. Kevzara’s entry was strategic, with a list price 30% lower than the two most widely used TNF-alpha drugs, aiming to capture market share through competitive pricing[4].

Clinical Efficacy and Differentiation

Kevzara has demonstrated significant clinical efficacy, particularly in head-to-head studies against Humira. It has shown the ability to stall the progression of joint damage and reduce symptoms and improve physical function in RA patients[4].

Key Clinical Benefits

• Radiographic Progression: Kevzara has been shown to control radiographic progression of structural damage, a critical aspect in the long-term management of RA[4].
• Symptom Reduction: The drug has demonstrated great efficacy in reducing symptoms and improving physical function in patients.

Pricing Strategy

The pricing strategy of Kevzara was a key factor in its market positioning. With a list price of $39,000 per year, it was positioned as a more affordable alternative to other RA treatments[4].

Financial Performance

Initial Sales and Growth

In the initial years following its approval, Kevzara saw steady growth, although it faced significant competition. The drug was part of Sanofi’s immunology franchise, which was expected to generate substantial revenue.

Recent Trends

While specific recent financial data for Kevzara alone is not detailed in the latest reports, the overall performance of Sanofi and Regeneron can provide insights into the broader context.

• Sanofi’s Financials: Sanofi’s Specialty Care segment, which includes Kevzara, saw mixed results in 2023. While Dupixent drove significant growth, other products faced challenges due to increased competition and market dynamics[1].
• Regeneron’s Financials: Regeneron reported revenue growth in 2023, driven by its core products, but did not provide a detailed breakdown for Kevzara specifically. The company's overall revenue growth indicates a strong performance across its portfolio[2].

Market Challenges

Competition and Pricing Pressure

Kevzara faces intense competition from established and new entrants in the RA market. Pricing pressure remains a significant challenge, as the market is highly sensitive to pricing strategies[4].

Changing Market Dynamics

The RA market is subject to changing dynamics, including the impact of biosimilars and new treatment options. This has led to fluctuations in sales volumes and pricing for Kevzara and other RA treatments[3].

Future Outlook

Pipeline and Expansion

Sanofi and Regeneron continue to invest in their R&D pipelines, which could lead to new indications or formulations for Kevzara. However, the immediate focus remains on navigating the competitive RA market[1].

Strategic Positioning

To maintain market share, Kevzara will need to continue demonstrating its clinical benefits and value proposition to healthcare providers and patients. Strategic partnerships and marketing efforts will be crucial in this endeavor.

Key Takeaways

• Competitive Pricing: Kevzara’s lower list price compared to other TNF-alpha inhibitors was a key strategy to capture market share.
• Clinical Efficacy: The drug has shown significant clinical benefits, particularly in controlling radiographic progression and reducing symptoms.
• Market Challenges: Intense competition and changing market dynamics pose ongoing challenges for Kevzara.
• Future Outlook: Continued investment in R&D and strategic positioning will be essential for maintaining and growing Kevzara’s market presence.

FAQs

What is Kevzara used for?

Kevzara is used for the treatment of rheumatoid arthritis (RA), specifically targeting the interleukin-6 receptor.

How does Kevzara differentiate itself in the RA market?

Kevzara differentiates itself through its clinical efficacy, particularly in controlling radiographic progression of joint damage and reducing symptoms, as well as its competitive pricing strategy.

What are the main challenges faced by Kevzara in the market?

Kevzara faces intense competition from established and new RA treatments, as well as pricing pressure and changing market dynamics.

How has Kevzara performed financially since its approval?

While specific financial data for Kevzara is not always detailed, it has been part of Sanofi’s growing immunology franchise. The overall financial performance of Sanofi and Regeneron indicates a strong but competitive market environment.

What is the future outlook for Kevzara?

The future outlook for Kevzara involves continued investment in R&D, strategic positioning to maintain market share, and demonstrating its clinical benefits to healthcare providers and patients.

Sources

1. Sanofi Press Release Q4 2023: Full-year 2023 financial results and business updates.
2. Regeneron Reports Fourth Quarter and Full Year 2023 Financial: Financial performance and business highlights.
3. Regeneron Corporate Presentation: Overview of Regeneron’s products and market dynamics.
4. FiercePharma: Sanofi, Regeneron set Kevzara up for tough RA market: Market entry and competitive landscape of Kevzara.