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Last Updated: February 12, 2025

ERELZI Drug Profile


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Summary for Tradename: ERELZI
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
  2. 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.

  3. General brand-side disclosures
  4. 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.

  5. Patents from broad patent text search
  6. 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 ERELZI Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

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

No patents found based on company disclosures

ERELZI Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory of Erelzi

Introduction to Erelzi

Erelzi, a biosimilar of the biologic drug etanercept, has been a significant player in the pharmaceutical market, particularly in Poland. Etanercept is used primarily for treating autoimmune diseases such as rheumatoid arthritis and psoriatic arthritis.

Market Competition and Pricing Trends

  1. Initial Market Competition (2017-2022):

    • Erelzi dominated the market with the largest total tender volume (59%), followed by Enbrel (31%) and Benepali (10%) [1].
    • The mean price per etanercept daily defined dose (DDD) was €7.28 for Erelzi, €8.34 for Enbrel, and €9.45 for Benepali [1].
  2. Price Fluctuations Post-Market Re-Monopolization:

    • After market re-monopolization by Erelzi, the mean price of winning bids increased to €8.09 and continued to rise to €9.71 in the last six months of available follow-up [1].
    • In the most recent tenders, mean ETN prices increased up to €15.82, nearly tripling the lowest prices of the competitive market period [1].
  3. Impact on Healthcare Costs:

    • The study found that market remonopolization led to significant price increases, resulting in over €3.42 million in excess healthcare costs due to higher treatment costs for patients and the healthcare system [4].

Financial Performance and Impact on Healthcare Systems

  1. Financial Highlights:

    • Erelzi's dominance in the market led to substantial financial gains for its manufacturer, Sandoz. The company reported a 7% growth in net sales to third parties in constant currencies for 2023, with core EBITDA reaching USD 1.7 billion [5].
  2. Economic Impact on Healthcare Systems:

    • The remonopolization of Erelzi resulted in higher treatment costs for patients and excess costs for the healthcare system. The average monthly cost of etanercept reimbursement decreased initially but then significantly increased, leading to calculated losses for public payers and potential financial losses for hospitals if tender prices had remained competitive [4].

Regulatory Incentives and Market Dynamics

  1. Regulatory Incentives for Affordable Biologics:

    • Higher ETN prices resulted in the downstream failure of regulatory incentives to promote affordable biologics. The initial competitive pricing led to lower costs for patients but was disrupted by market re-monopolization [1].
  2. Need for Effective Market Regulation:

    • The study highlights the need for effective market regulation to maintain competitive pricing and ensure broader access to treatments. This is crucial to prevent price increases that reduce the benefits of cost reductions and impact patient access [4].

Global Market Trends and Biosimilar Penetration

  1. Global Biologics Market Trends:

    • The global biologics market is growing, with biosimilars gaining significant market share. For example, Amgevita, Imraldi, and Hyrimoz together have approximately 6% market share of the adalimumab market, while Inflectra and Remsima together have approximately 24% market share of the infliximab market [3].
  2. Biosimilar Penetration in MEA Markets:

    • Biosimilars have shown high penetration in Middle East and Africa (MEA) markets, with biologics' value share growing 14.5% annually from 2015 to 2019 [3].

Conclusion and Key Takeaways

  1. Market Dynamics:

    • Erelzi's market dynamics are influenced by both competitive and monopolistic conditions. Initially, it dominated the market with competitive pricing, but market re-monopolization led to significant price increases.
  2. Financial Trajectory:

    • The financial trajectory of Erelzi is marked by substantial growth in net sales and core EBITDA. However, this growth is offset by higher treatment costs and excess healthcare costs due to market re-monopolization.
  3. Regulatory Implications:

    • Effective market regulation is crucial to maintain competitive pricing and ensure broader access to treatments. This is essential for preventing price increases that reduce the benefits of cost reductions and impact patient access.

Key Takeaways

  1. Market Dominance: Erelzi dominated the etanercept market with the largest total tender volume during the competitive period.
  2. Price Fluctuations: Prices significantly increased after market re-monopolization, nearly tripling the lowest competitive prices.
  3. Economic Impact: Higher treatment costs resulted in over €3.42 million in excess healthcare costs due to market monopoly.
  4. Regulatory Need: Effective market regulation is necessary to maintain competitive pricing and ensure broader access to treatments.

FAQs

  1. What was the initial mean price of Erelzi per DDD during the competitive period?

    • The initial mean price of Erelzi per DDD was €7.28 [1].
  2. How did the mean price of Erelzi change after market re-monopolization?

    • The mean price of Erelzi increased to €8.09 and continued to rise, reaching €9.71 in the last six months of available follow-up [1].
  3. What were the excess healthcare costs due to market monopoly?

    • The excess healthcare costs due to market monopoly were estimated at over €3.42 million [4].
  4. How did the financial performance of Sandoz impact the market dynamics of Erelzi?

    • Sandoz reported a 7% growth in net sales to third parties in constant currencies for 2023, with core EBITDA reaching USD 1.7 billion [5].
  5. What is the significance of effective market regulation in maintaining competitive pricing?

    • Effective market regulation is crucial to prevent price increases that reduce the benefits of cost reductions and impact patient access [4].

Cited Information

  1. [1] Charting the Etanercept Journey: Tracing Cost Dynamics in Poland's Healthcare System.
  2. [3] Realizing Biosimilar Potential in the Middle East & Africa - IQVIA.
  3. [4] The Economic Impact of Etanercept Biosimilar Remonopolization in Poland.
  4. [5] Sandoz 2023 Integrated Annual Report.

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