Infliximab-abda - Biologic Drug Details

Summary for infliximab-abda

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Suppliers: see list	1

Pharmacology for infliximab-abda

Mechanism of Action	Tumor Necrosis Factor Receptor Blocking Activity
Established Pharmacologic Class	Tumor 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

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. DrugPatentWatch analysis and 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 infliximab-abda Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for infliximab-abda Derived from DrugPatentWatch Analysis and Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for infliximab-abda Derived from Patent Text Search

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for Infliximab-abda

Last updated: March 9, 2026

What is Infliximab-abda?

Infliximab-abda, marketed as Zessly by Fresenius Kabi, is a biosimilar to the reference biologic infliximab (Remicade). It is an anti-TNF alpha monoclonal antibody indicated for autoimmune conditions such as rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis.

Market Position and Regulatory Status

• Approval Status: Approved in the European Union (EU) since 2017; received FDA approval on February 20, 2019[1].
• Manufacturing: Produced by Fresenius Kabi, with manufacturing facilities compliant with Good Manufacturing Practice (GMP) standards.
• Indications: Same as reference infliximab, reimbursed across multiple regions, including the US, EU, and parts of Asia.

Market Size and Share

• Global Market: The infliximab market was valued at approximately USD 15 billion in 2022. Biosimilars account for roughly 40% of infliximab prescriptions in key markets by 2023[2].
• Region Breakdown:
  • Europe: Largest biosimilar uptake, with infliximab biosimilar penetration approaching 70% of total prescriptions.
  • US: Slower biosimilar adoption; estimated at approximately 35% in the same period[3].
• Pricing Trends: Biosimilars generally priced 15–30% below the original biologic. Infliximab biosimilars, including infliximab-abda, are sold at significant discounts, impacting revenue streams.

Market Dynamics

Entry Barriers and Competitive Landscape

• Regulatory Barriers: Biologic biosimilar approvals require demonstrating high similarity to reference products, involving extensive preclinical and clinical data.
• Manufacturing Complexity: The production of infliximab biosimilars involves complex cell-line validation and process consistency.
• Patent Landscape: While initial patents expired around 2018–2019, some secondary patents and exclusivity periods delay market entry of newer biosimilars.
• Competitive Differentiation: Most biosimilars, including infliximab-abda, compete primarily on price; minor efficacy variations do not influence prescriber choice significantly.

Pricing Strategies and Reimbursement Policies

• Pricing: Biosimilars are priced approximately 20% lower than the reference biologic. Market competition can further drive discounts[4].
• Reimbursement: Policies in Europe favor biosimilar substitution to control healthcare costs; US Medicaid and Medicare programs actively promote biosimilar use.
• Market Access: Channels vary; hospitals and specialty clinics prefer biosimilars when reimbursement and formulary inclusion favor their use.

Prescriber and Patient Acceptance

• Prescribing patterns depend heavily on clinician familiarity and confidence in biosimilar comparability.
• Exchangeability policies influence substitution at the pharmacy level. Some regions permit automatic substitution, boosting biosimilar uptake.
• Patient acceptance hinges on education about biosimilar safety and efficacy; ongoing pharmacovigilance supports confidence levels.

Financial Trajectory

Revenue Projections

• 2023–2028 Forecast: Global infliximab biosimilar sales expected to grow at a compound annual growth rate (CAGR) of 10–12%, driven by expanding indications and increased adoption in emerging markets.
• Market Share Growth: European biosimilar penetration projected to reach 85% by 2025; US growth to approach 50% with the expansion of interchangeability policies.
• Pricing Dynamics: Continued price erosion anticipated, with average biosimilar prices declining 5–10% annually.

Impact on Original Manufacturer Revenue

• Reference infliximab sales declined 15% globally since biosimilar introductions, with some markets experiencing sharper drops.
• Fresenius Kabi’s infliximab-abda accounts for a significant share of their biosimilar portfolio; revenue depends on regional volume uptake.

Investment and R&D Outlook

• Biosimilar manufacturers focus on expanding indications and improving manufacturing efficiencies.
• Investment in new formulations, such as subcutaneous versions, aims to capture market share from the original biologic and early biosimilars.

Key Market Drivers and Constraints

Drivers	Constraints
Cost savings from biosimilar adoption	Prescriber hesitancy due to safety/perception issues
Regulatory support for biosimilar policies	Patent litigations and secondary patent protections for original biologics
Expanding indications and brand familiarity	Market fragmentation and regional reimbursement disparities

Conclusions

Infliximab-abda's market outlook hinges on biosimilar adoption rates influenced by regulatory, reimbursement, and prescriber behaviors. The ongoing pricing competition pressures revenues of reference infliximab products. Strategic focus on expanding indications, optimizing manufacturing, and navigating regional policies will shape its financial trajectory.

Key Takeaways

• Infliximab-abda entered the market as a biosimilar to infliximab, with approvals in Europe and the US.
• The biosimilar segment is experiencing rapid growth, driven by cost savings and supportive policies, especially in Europe.
• Revenue growth for infliximab biosimilars is constrained by price erosion and market saturation.
• Competition intensifies as multiple biosimilars reach market entry, with price discounts achieving up to 30% below reference prices.
• Regional differences in market access and prescriber trust significantly impact sales trajectories.

FAQs

1. How does infliximab-abda compare pricing-wise to other biosimilars?
It is typically priced 15–20% below the reference infliximab, with prices further decreasing as more biosimilars enter the market.

2. What factors influence biosimilar adoption in different regions?
Regulatory policies, reimbursement landscape, prescriber confidence, and substitute policies impact adoption rates.

3. How are manufacturers competing beyond pricing?
By expanding indications, improving manufacturing efficiency, and developing formulations like subcutaneous options.

4. What is the role of patent litigation in market penetration?
Secondary patents and legal disputes can delay biosimilar market entry, affecting timelines and revenues.

5. What are the primary growth markets for infliximab biosimilars?
Europe and emerging markets in Asia and Latin America exhibit faster adoption rates, with the US showing gradual growth.

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References

[1] U.S. Food and Drug Administration. (2019). Infiximab-abda approval letter. https://www.fda.gov

[2] IQVIA. (2023). World Biosimilar Market Report.

[3] EvaluatePharma. (2023). Global Biosimilar Market Share Analysis.

[4] IMS Health. (2022). Biosimilar Pricing Trends.