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Last Updated: March 15, 2025

RENFLEXIS Drug Profile


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Summary for Tradename: RENFLEXIS
High Confidence Patents:0
Applicants:1
BLAs:1
Recent Clinical Trials: See clinical trials for RENFLEXIS
Recent Clinical Trials for RENFLEXIS

Identify potential brand extensions & biosimilar entrants

SponsorPhase
Children's Hospital Medical Center, CincinnatiPhase 2/Phase 3
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Phase 2/Phase 3
Massachusetts Institute of TechnologyPhase 2

See all RENFLEXIS clinical trials

Pharmacology for RENFLEXIS
Mechanism of ActionTumor Necrosis Factor Receptor Blocking Activity
Established Pharmacologic ClassTumor Necrosis Factor Blocker
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 RENFLEXIS Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

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

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for the Biologic Drug: Renflexis

Introduction

Renflexis, a biosimilar of infliximab, is a crucial player in the biologic drug market, particularly in the treatment of autoimmune diseases such as rheumatoid arthritis, Crohn's disease, and ulcerative colitis. This article delves into the market dynamics and financial trajectory of Renflexis, highlighting key trends, market share, and price dynamics.

Market Share of Renflexis

As of Q1 2024, the infliximab biosimilar market, which includes Renflexis, has seen significant growth. The biosimilar share of the infliximab market has reached 54%, indicating a substantial shift away from the reference product, Remicade[4].

Volume Market Share

Renflexis, along with other biosimilars like Inflectra and Avsola, has carved out a notable market share. As of Q3 2023, Renflexis held around 10% of the volume market share in the infliximab market, while Inflectra and Avsola held 6% and 10%, respectively. The unbranded infliximab, launched by Janssen in Q4 2022, also contributed to the market share, further eroding the dominance of Remicade[4].

Price Trends and Erosion

The entry of biosimilars, including Renflexis, has led to significant price erosion in the infliximab market.

Average Sales Price (ASP)

As of Q1 2024, the average ASP of all infliximab products, including biosimilars, was $236, representing a 70% decrease from the reference product's ASP at the time of the first biosimilar launch. For biosimilars alone, the average ASP was $214, a 73% decrease[4].

Price Erosion Impact

The launch of biosimilars has driven down prices, offering substantial savings to payers and patients. For instance, the ASP of Renflexis and other biosimilars has declined significantly, contributing to an overall reduction in treatment costs. This trend is consistent with broader market observations where biologics facing biosimilar competition experience price decreases[3].

Competitive Landscape

The infliximab market is highly competitive, with multiple biosimilars vying for market share.

Key Players

  • Remicade: The reference product, which has seen its market share decline significantly.
  • Inflectra: Another biosimilar that has been in the market for several years.
  • Avsola: A more recent entrant that has gained traction.
  • Unbranded Infliximab: Launched by Janssen, this has further intensified competition[4].

Financial Impact on Manufacturers

The financial trajectory of manufacturers of biosimilars like Renflexis is influenced by several factors, including market share, pricing, and competition.

Revenue and Profitability

For companies like Samsung Bioepis, which manufactures Renflexis, the revenue from biosimilars contributes significantly to their overall financial performance. However, the intense competition and price erosion can impact profitability. Manufacturers must balance pricing strategies with market share goals to maintain financial viability[4].

Impact on Payers and Patients

The entry of biosimilars like Renflexis has significant implications for payers and patients.

Cost Savings

Biosimilars offer substantial cost savings, which can be beneficial for both payers and patients. The reduced ASPs of biosimilars can lead to lower treatment costs, making these therapies more accessible[3].

Access to Treatment

Increased competition and lower prices enhance access to treatment for patients who might not have been able to afford the reference product. This is particularly important in chronic disease management, where long-term treatment is often necessary.

Future Outlook

The future outlook for Renflexis and the broader biosimilar market is promising but challenging.

Market Growth

The biosimilar market is expected to grow as more biologics lose patent protection and new biosimilars enter the market. This growth will be driven by increasing acceptance of biosimilars by healthcare providers and payers[4].

Regulatory Environment

Regulatory changes and policies can significantly impact the biosimilar market. Favorable regulatory environments can facilitate the approval and launch of new biosimilars, further driving market growth.

Competitive Strategies

Manufacturers will need to adopt competitive pricing strategies and invest in marketing and education to maintain and grow their market share. This includes formulary placement and negotiating with payers to ensure favorable positioning.

Key Takeaways

  • Market Share: Renflexis holds a significant share in the infliximab biosimilar market, contributing to the overall 54% biosimilar share.
  • Price Erosion: The entry of biosimilars has led to a 70% decrease in ASP for infliximab products.
  • Competitive Landscape: The market is highly competitive with multiple biosimilars, including Inflectra, Avsola, and an unbranded infliximab.
  • Financial Impact: Manufacturers face challenges in maintaining profitability due to intense competition and price erosion.
  • Patient and Payer Benefits: Biosimilars offer substantial cost savings and improved access to treatment.

FAQs

What is Renflexis?

Renflexis is a biosimilar of infliximab, used in the treatment of autoimmune diseases such as rheumatoid arthritis, Crohn's disease, and ulcerative colitis.

How has the market share of Renflexis evolved?

As of Q1 2024, Renflexis holds around 10% of the volume market share in the infliximab market, contributing to the overall 54% biosimilar share.

What is the impact of biosimilars on the ASP of infliximab?

The average ASP of infliximab products, including biosimilars, has decreased by 70% as of Q1 2024, offering significant cost savings.

How does the competitive landscape affect Renflexis?

The infliximab market is highly competitive, with multiple biosimilars and an unbranded infliximab launched by Janssen, which further intensifies competition.

What are the benefits of biosimilars like Renflexis for patients and payers?

Biosimilars offer substantial cost savings and improved access to treatment, making therapies more affordable for patients and reducing healthcare expenditures for payers.

Sources

  1. Samsung Bioepis: Biosimilar Market Dynamics - SAMSUNG BIOEPIS[1].
  2. Organon: Organon Reports Results for the Fourth Quarter and Full Year Ended December 31, 2023[2].
  3. Tandfonline: Estimating the impact of biosimilar entry on prices and expenditures[3].
  4. Samsung Bioepis: Biosimilar Market Report - SAMSUNG BIOEPIS[4].

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