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Last Updated: February 8, 2025

RIABNI Drug Profile


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

Identify potential brand extensions & biosimilar entrants

SponsorPhase
Fate TherapeuticsPhase 1
Markus MaparaPhase 1/Phase 2
ITB-Med LLCPhase 1/Phase 2

See all RIABNI clinical trials

Pharmacology for RIABNI
Mechanism of ActionCD20-directed Antibody Interactions
Established Pharmacologic ClassCD20-directed Cytolytic Antibody
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 RIABNI Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

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

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for the Biologic Drug: Riabni

Introduction to Riabni

Riabni is a biosimilar of the biologic drug rituximab, which is used to treat various conditions including non-Hodgkin lymphoma, chronic lymphocytic leukemia, and certain autoimmune diseases. Understanding the market dynamics and financial trajectory of Riabni is crucial for stakeholders in the pharmaceutical industry.

Market Share and Competition

As of Q3 2024, the biosimilar share of the rituximab market has reached 75%, with Riabni being one of the key players[1].

  • Volume Market Share: Riabni, along with other biosimilars like Truxima and Ruxience, has been gaining market share. Riabni, in particular, has started to grow its market share as its Average Sales Price (ASP) declines[1].
  • Competitive Landscape: The rituximab market is highly competitive, with multiple biosimilars vying for market share. Riabni competes directly with other biosimilars such as Truxima and Ruxience, as well as the original biologic, Rituxan.

Pricing Trends

Pricing is a critical factor in the biosimilar market, and Riabni has seen significant price reductions.

  • Average Sales Price (ASP): The ASP of Riabni and other biosimilars has declined substantially. As of Q3 2024, the average ASP of all rituximab products is $1,863, down 58% from the reference product's ASP at the time of the first biosimilar launch. For biosimilars alone, the average ASP is $1,262, down 72%[1].
  • Price Competition: The decline in ASP is driven by intense competition among biosimilars. As more biosimilars enter the market, prices are expected to continue to drop, making these drugs more accessible to patients.

Market Size and Growth

The rituximab biosimilars market is experiencing rapid growth.

  • Current Market Size: The market size for rituximab biosimilars was $2.66 billion in 2023 and is expected to grow to $3.02 billion in 2024, representing a compound annual growth rate (CAGR) of 13.3%[4].
  • Future Projections: By 2028, the market is projected to reach $4.89 billion, with a CAGR of 12.8%. This growth is driven by factors such as an aging population, improved access to healthcare, and an increasing prevalence of chronic diseases[3][4].

Drivers of Growth

Several factors are driving the growth of the rituximab biosimilars market.

  • Government Initiatives: Government policies and initiatives aimed at reducing healthcare costs and increasing access to biologic treatments are boosting the market[4].
  • Increased Healthcare Expenditure: Rising healthcare expenditure globally is another significant driver. As more countries invest in healthcare infrastructure, the demand for biosimilars like Riabni increases[4].
  • Research and Development: Continuous investments in research and development activities to create effective and innovative biosimilars are also driving market growth[3][4].

Strategic Partnerships and Collaborations

To stay competitive, companies are forming strategic partnerships and collaborations.

  • Collaboration Agreements: Major players in the biosimilar market are forging collaboration agreements to expand their research and development activities. These partnerships help in broadening the scope of new drug developments and improving the efficacy of existing biosimilars[3][4].
  • Regulatory Support: Updated FDA regulations for the development of biosimilar drugs are also facilitating the growth of the market. These regulations provide clearer guidelines and faster approval processes, encouraging more companies to enter the market[3].

Financial Performance

The financial performance of companies involved in the biosimilar market, including those producing Riabni, is influenced by several factors.

  • Revenue Growth: The revenue from rituximab biosimilars is expected to grow significantly due to the increasing market size and penetration. Companies like Samsung Bioepis, which produces Riabni, are likely to see revenue growth as their market share increases[1][3].
  • Cost Savings: The decline in ASP, while beneficial for patients, can impact the revenue of individual products. However, companies often offset this through increased volume sales and cost savings from efficient manufacturing processes[1].

Challenges and Opportunities

Despite the growth, there are challenges and opportunities in the biosimilar market.

  • Regulatory Challenges: Navigating regulatory environments can be complex. Companies must comply with evolving FDA regulations and other international standards to ensure their products remain approved and competitive[3].
  • Market Penetration: The opportunity to expand into emerging markets and increase market penetration is significant. As healthcare access improves in these regions, the demand for affordable biosimilars like Riabni is expected to rise[4].

Key Takeaways

  • Market Share and Pricing: Riabni is gaining market share in the rituximab biosimilars market, driven by declining ASPs.
  • Market Growth: The rituximab biosimilars market is expected to grow significantly, driven by government initiatives, increased healthcare expenditure, and rising chronic disease prevalence.
  • Strategic Partnerships: Collaboration agreements and updated FDA regulations are crucial for market growth and innovation.
  • Financial Performance: Revenue growth is expected, but companies must manage the impact of declining ASPs through cost savings and increased volume sales.

FAQs

What is Riabni?

Riabni is a biosimilar of the biologic drug rituximab, used to treat conditions such as non-Hodgkin lymphoma and chronic lymphocytic leukemia.

How is the market share of Riabni evolving?

As of Q3 2024, Riabni has started to grow its market share as its ASP declines, contributing to the overall 75% market share of biosimilars in the rituximab market[1].

What are the key drivers of the rituximab biosimilars market growth?

The growth is driven by government initiatives, increased healthcare expenditure, an aging population, improved access to healthcare, and an increasing prevalence of chronic diseases[3][4].

How do strategic partnerships impact the biosimilar market?

Strategic partnerships and collaboration agreements help in expanding research and development activities, broadening the scope of new drug developments, and improving the efficacy of existing biosimilars[3][4].

What are the financial implications of the declining ASP for Riabni?

While the decline in ASP can reduce revenue per unit, companies can offset this through increased volume sales and cost savings from efficient manufacturing processes[1].

What are the regulatory challenges in the biosimilar market?

Companies must comply with evolving FDA regulations and other international standards to ensure their products remain approved and competitive[3].

Sources

  1. Samsung Bioepis, "Biosimilar Market Dynamics - SAMSUNG BIOEPIS," Q3 2024.
  2. Amgen Inc., "SHAREHOLDERS - Investors | Amgen Inc.," February 14, 2024.
  3. Research and Markets, "Rituximab Biosimilars Global Market Size & Forecast to 2028."
  4. The Business Research Company, "Global Rituximab Biosimilars Market Report 2024."
  5. Amgen, "2022 Letter to Shareholders - Amgen," March 20, 2023.

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