Etanercept-szzs - Biologic Drug Details

Summary for etanercept-szzs

Tradenames:	2
High Confidence Patents:	0
Applicants:	1
BLAs:	1

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 etanercept-szzs Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for etanercept-szzs Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for etanercept-szzs Derived from Patent Text Search

No patents found based on company disclosures

Etanercept-szzs Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for Etanercept-szzs

Introduction to Etanercept-szzs

Etanercept-szzs, marketed under the brand name Erelzi, is a biosimilar version of the biologic drug etanercept. It is used to treat various autoimmune diseases such as rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and polyarticular juvenile idiopathic arthritis[2].

Market Share and Growth

The global etanercept market is projected to grow at a Compound Annual Growth Rate (CAGR) of 4.5% from 2024 to 2033, reaching $27.0 billion by 2033[3]. This growth is driven by increasing healthcare expenditure, rising prevalence of autoimmune diseases, and favorable reimbursement policies in developed regions.

Competitive Landscape

The etanercept market faces competition from biosimilar versions of etanercept, which pose significant challenges to branded products. The emergence of biosimilars like Erelzi has influenced pricing strategies and market share dynamics. Despite these challenges, Erelzi has been approved for all indications included in the reference product's label, expanding its potential patient population[2][3].

Regulatory Environment

The FDA approval of Erelzi in 2016 was based on a comprehensive package of analytical, nonclinical, and clinical data confirming its similarity to the US-licensed reference product. However, patent litigation from Amgen covering the active ingredient in Enbrel has blocked Sandoz's ability to launch Erelzi in the US until 2029[4].

Financial Impact

The inability to launch Erelzi in the US due to patent litigation has significant financial implications. Estimates suggest that a biosimilar etanercept could have saved the US healthcare system around $1 billion per year[4]. This highlights the potential financial benefits of biosimilars in reducing healthcare costs.

Market Opportunities

Despite regulatory hurdles, emerging markets present growth opportunities for etanercept manufacturers. Increasing healthcare expenditure and rising prevalence of autoimmune diseases in emerging markets like China and India offer substantial market opportunities for etanercept manufacturers[3].

Patient Preference and Adoption

Patient preference for biologic medications, including etanercept, drives market growth. The convenience and effectiveness of etanercept therapy, enhanced by technological innovations in drug delivery systems, contribute to its adoption[3].

Challenges and Future Outlook

The etanercept market faces challenges such as adverse effects and safety concerns, which may lead to hesitancy among prescribers and patients. Additionally, regulatory reforms and changes in market access policies influence market dynamics and competitive positioning of etanercept. Despite these challenges, the market is expected to grow due to expanding indications and emerging therapeutic targets[3].

Key Takeaways

1. Market Growth: The global etanercept market is projected to grow at a CAGR of 4.5% from 2024 to 2033.
2. Competitive Landscape: Biosimilars like Erelzi pose significant challenges to branded products in terms of pricing and market share.
3. Regulatory Environment: Patent litigation has blocked Sandoz's ability to launch Erelzi in the US until 2029.
4. Financial Impact: Biosimilar etanercept could have saved the US healthcare system around $1 billion per year.
5. Market Opportunities: Emerging markets present substantial growth opportunities for etanercept manufacturers.
6. Patient Preference: Patient preference for biologic medications drives market growth.

FAQs

1. What is Etanercept-szzs?

   • Etanercept-szzs, marketed as Erelzi, is a biosimilar version of etanercept used to treat autoimmune diseases.

2. What is the projected growth rate of the etanercept market?

   • The global etanercept market is projected to grow at a CAGR of 4.5% from 2024 to 2033[3].

3. Why has Sandoz been unable to launch Erelzi in the US?

   • Patent litigation from Amgen covering the active ingredient in Enbrel has blocked Sandoz's ability to launch Erelzi in the US until 2029[4].

4. What are the potential financial benefits of biosimilar etanercept?

   • A biosimilar etanercept could have saved the US healthcare system around $1 billion per year[4].

5. What are the emerging market opportunities for etanercept manufacturers?

   • Increasing healthcare expenditure and rising prevalence of autoimmune diseases in emerging markets like China and India offer substantial market opportunities for etanercept manufacturers[3].

Sources Cited

1. [1] Samsung Bioepis - Biosimilar Market Report Q3 2024
2. [2] Novartis - FDA Approves Sandoz Erelzi(TM) to Treat Multiple Inflammatory Diseases
3. [3] Marketresearch.biz - Etanercept Market Projected to Grow at 4.5% CAGR, Crossing US$ 27.0 Billion by 2033
4. [4] Biopharma-Reporter - Sandoz Sees Route to Market with Enbrel Biosim Blocked Until 2029