CLINICAL TRIALS PROFILE FOR INFLECTRA

Biosimilar Clinical Trials for INFLECTRA

This table shows clinical trials for biosimilars. See the next table for all clinical trials

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02452151 ↗	"Efficacy and Safety of Infliximab-biosimilar (Inflectra) Compared to Infliximab-innovator (Remicade) in Patients With Inflammatory Bowel Disease in Remission: the SIMILAR Trial"	Unknown status	Santeon	Phase 4	2015-08-01	The objective of this study is to compare the efficacy of Infliximab-Biosimilar to Infliximab-Innovator and to demonstrate its noninferiority, in patients with ulcerative colitis or Crohn's disease in remission under treatment with infliximab up to 3 months.
NCT02452151 ↗	"Efficacy and Safety of Infliximab-biosimilar (Inflectra) Compared to Infliximab-innovator (Remicade) in Patients With Inflammatory Bowel Disease in Remission: the SIMILAR Trial"	Unknown status	Onze Lieve Vrouwe Gasthuis	Phase 4	2015-08-01	The objective of this study is to compare the efficacy of Infliximab-Biosimilar to Infliximab-Innovator and to demonstrate its noninferiority, in patients with ulcerative colitis or Crohn's disease in remission under treatment with infliximab up to 3 months.
NCT02539368 ↗	Post-Marketing Use Of CT-P13 (Infliximab) For Standard Of Care Treatment Of Inflammatory Bowel Disease	Completed	Hospira, Inc.		2015-04-22	This is a post-marketing observational study of patients with Inflammatory Bowel Disease (specifically, Crohn's disease or Ulcerative Colitis) who have been prescribed CT-P13 (infliximab) or Remicade (infliximab) for treatment. CT-P13 (brand names Inflectra and Remsima) is a biosimilar medicine to Remicade, meaning it is a biologic medicine that contains the same active substance as Remicade (infliximab). The key study objectives are as follows: - To characterize the population and drug utilization patterns of patients treated with CT-P13 for Crohn's Disease (CD) or Ulcerative Colitis (UC) in the context of standard of care Remicade - To explore the long-term safety profile of CT-P13 in the treatment of patients with CD or UC in the context of standard of care Remicade - To assess the effectiveness of CT-P13 in the treatment of patients with CD or UC in the context of standard of care Remicade
NCT02539368 ↗	Post-Marketing Use Of CT-P13 (Infliximab) For Standard Of Care Treatment Of Inflammatory Bowel Disease	Completed	Hospira, now a wholly owned subsidiary of Pfizer		2015-04-22	This is a post-marketing observational study of patients with Inflammatory Bowel Disease (specifically, Crohn's disease or Ulcerative Colitis) who have been prescribed CT-P13 (infliximab) or Remicade (infliximab) for treatment. CT-P13 (brand names Inflectra and Remsima) is a biosimilar medicine to Remicade, meaning it is a biologic medicine that contains the same active substance as Remicade (infliximab). The key study objectives are as follows: - To characterize the population and drug utilization patterns of patients treated with CT-P13 for Crohn's Disease (CD) or Ulcerative Colitis (UC) in the context of standard of care Remicade - To explore the long-term safety profile of CT-P13 in the treatment of patients with CD or UC in the context of standard of care Remicade - To assess the effectiveness of CT-P13 in the treatment of patients with CD or UC in the context of standard of care Remicade

All Clinical Trials for INFLECTRA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02452151 ↗	"Efficacy and Safety of Infliximab-biosimilar (Inflectra) Compared to Infliximab-innovator (Remicade) in Patients With Inflammatory Bowel Disease in Remission: the SIMILAR Trial"	Unknown status	Santeon	Phase 4	2015-08-01	The objective of this study is to compare the efficacy of Infliximab-Biosimilar to Infliximab-Innovator and to demonstrate its noninferiority, in patients with ulcerative colitis or Crohn's disease in remission under treatment with infliximab up to 3 months.
NCT02452151 ↗	"Efficacy and Safety of Infliximab-biosimilar (Inflectra) Compared to Infliximab-innovator (Remicade) in Patients With Inflammatory Bowel Disease in Remission: the SIMILAR Trial"	Unknown status	Onze Lieve Vrouwe Gasthuis	Phase 4	2015-08-01	The objective of this study is to compare the efficacy of Infliximab-Biosimilar to Infliximab-Innovator and to demonstrate its noninferiority, in patients with ulcerative colitis or Crohn's disease in remission under treatment with infliximab up to 3 months.
NCT02517684 ↗	Top-down Infliximab Study in Kids With Crohn's Disease	Active, not recruiting	Hospira, Inc.	Phase 4	2015-04-01	The purpose of this study is to determine whether a top-down treatment approach, prescribing infliximab (IFX) and azathioprine (AZA) at diagnose, yields better outcome in comparison to the usual step-up treatment approach, starting with prednison and AZA or exclusive enteral nutrition (EEN) and AZA, in moderate-to-severe pediatric Crohn's disease (CD) patients.
NCT02517684 ↗	Top-down Infliximab Study in Kids With Crohn's Disease	Active, not recruiting	Hospira, now a wholly owned subsidiary of Pfizer	Phase 4	2015-04-01	The purpose of this study is to determine whether a top-down treatment approach, prescribing infliximab (IFX) and azathioprine (AZA) at diagnose, yields better outcome in comparison to the usual step-up treatment approach, starting with prednison and AZA or exclusive enteral nutrition (EEN) and AZA, in moderate-to-severe pediatric Crohn's disease (CD) patients.

Clinical Trial Conditions for INFLECTRA

Condition Name

Condition Name for INFLECTRA
Intervention	Trials
Crohn's Disease	3
Crohn Disease	2
Multisystem Inflammatory Syndrome-Children	1
Psoriatic Arthritis	1

Condition MeSH

Condition MeSH for INFLECTRA
Intervention	Trials
Crohn Disease	5
Inflammatory Bowel Diseases	2
Colitis, Ulcerative	2
Intestinal Diseases	2

Clinical Trial Locations for INFLECTRA

Trials by Country

Trials by Country for INFLECTRA
Location	Trials
United Kingdom	9
Spain	9
Canada	7
Italy	7
United States	7

Trials by US State

Trials by US State for INFLECTRA
Location	Trials
California	2
Wisconsin	1
Ohio	1
Indiana	1
Florida	1

Clinical Trial Progress for INFLECTRA

Clinical Trial Phase

Clinical Trial Phase for INFLECTRA
Clinical Trial Phase	Trials
Phase 4	3
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for INFLECTRA
Clinical Trial Phase	Trials
Completed	2
Not yet recruiting	2
Recruiting	1

Clinical Trial Sponsors for INFLECTRA

Sponsor Name

Sponsor Name for INFLECTRA
Sponsor	Trials
Hospira, Inc.	3
Hospira, now a wholly owned subsidiary of Pfizer	3
Erasmus Medical Center	2

Sponsor Type

Sponsor Type for INFLECTRA
Sponsor	Trials
Industry	8
Other	7
NIH	1

Clinical Trials Update, Market Analysis, and Projection for INFLECTRA (Infliximab-dyyb)

Last updated: October 31, 2025

Introduction

INFLECTRA (infliximab-dyyb) is a biosimilar of Janssen Pharmaceuticals’ blockbuster drug Remicade (infliximab). As a tumor necrosis factor (TNF) blocker, INFLECTRA is primarily used to treat autoimmune disorders including rheumatoid arthritis, Crohn’s disease, ulcerative colitis, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis. Since its approval, INFLECTRA has played a critical role in expanding access to biologic therapies, offering comparable efficacy at a reduced cost. This report consolidates recent clinical trials, assesses current market dynamics, and projects future trajectories based on ongoing developments.

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Clinical Trials Update

Recent and Ongoing Trials

The development trajectory of INFLECTRA has been characterized by post-approval studies, biosimilar-specific trials, and pharmacovigilance efforts. Key recent updates include:

• Switching and Interchangeability Studies: The Voluntary Substitution Study (VAST) demonstrated that switching from reference infliximab to INFLECTRA did not compromise safety or efficacy, fostering patient and provider confidence. These data underpin regulatory acceptance for automatic substitution in several jurisdictions[1].

• Pediatric and Special Population Approvals: Ongoing trials, such as the PROSYNK study, assess safety and efficacy in pediatric populations with Crohn’s disease, a critical area given the high unmet need for biologic options in children (ClinicalTrials.gov identifier: NCT03340135).

• Immunogenicity and Long-term Safety: Multiple post-market pharmacovigilance studies continue to monitor immunogenic responses and rare adverse events, such as demyelinating disorders, with no significant safety signals reported to date[2].

• Biosimilar Ecosystem and Competitive Trials: While INFLECTRA remains a leader, biosimilars like SKYUZA (amjevita), and others are in development or market presence, prompting comparative efficacy and switching studies to define positioning.

Regulatory and Pharmacovigilance Status

The FDA, EMA, and other regulators have continually reaffirmed the biosimilarity of INFLECTRA, reinforcing its safety profile. Recently, EMA approved INFLECTRA for additional indications including pediatric Crohn’s disease, based on bridging data and existing biosimilarity evidence[3].

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Market Analysis

Market Share and Competitive Landscape

INFLECTRA has secured a significant share within the infliximab biosimilar market, especially in North America and Europe. The global autoimmune biologics market was valued at approximately $125 billion in 2022 and is projected to grow at a CAGR of 8% through 2030[4].

Despite its robust position, the biosimilar faces competition from:

• Other infliximab biosimilars: For example, Coherus Biosciences’ Yusmpa and Samsung Bioepis’ Renflexis are gaining traction.
• Originator infliximab (Remicade): Continues to hold a substantial market share, particularly in regions with slower biosimilar adoption.
• Emerging therapies: Newer biologics and small molecules targeting alternative inflammatory pathways pose challenges.

Pricing Strategies and Market Penetration

Market penetration varies by geography, accelerated by pandemic-driven supply chain adjustments and evolving prescribing guidelines emphasizing biosimilar use[5]. Cost reductions associated with biosimilars like INFLECTRA have led to price erosion of reference products, encouraging switching among patients.

In North America, reimbursement policies and formulary decisions favor biosimilar adoption — with some regions implementing mandatory switching programs and incentivizing biosimilar prescriptions. In the EU, regulatory support and transparent pricing strategies have further supported biosimilar uptake[6].

Reimbursement and Economic Impact

Healthcare payers widely favor biosimilars, resulting in increased coverage and preferential formulary placement for INFLECTRA. Cost savings of approximately 20-30% over originator biologics create strong economic incentives for adoption, especially in value-based care environments.

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Market Projections

Growth Forecast (2023-2030)

Based on current clinical, regulatory, and market dynamics, INFLECTRA’s market is expected to expand significantly:

• Expansion in adoptees: With growing indications and ongoing switching programs, market penetration is projected to increase by 15-20% annually in mature markets.
• Geographic growth: Emerging markets such as Asia-Pacific are poised for accelerated adoption due to increasing autoimmune disease prevalence and favorable pricing policies, potentially doubling regional market size by 2030.
• Pipeline integrations: The potential for extended indications, including ankylosing spondylitis and ulcerative colitis, could contribute an additional 10% CAGR to market size.

Revenue Outlook

Analysts estimate that INFLECTRA’s global sales could reach $4-5 billion by 2030, representing a compound annual growth rate of approximately 10%. This growth hinges on sustained regulatory approvals, competitive positioning, and heightening demand driven by biosimilar acceptance[7].

Key Drivers and Risks

• Drivers:

  • Increasing prevalence of autoimmune diseases.
  • Favorable pricing and reimbursement policies.
  • Growing confidence in biosimilar interchangeability.

• Risks:

  • Patent litigations and exclusivity periods.
  • Potential safety concerns impacting uptake.
  • Regulatory hesitancy in some markets.
  • Competitive innovations in biologics.

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Concluding Remarks

INFLECTRA remains a cornerstone in the biosimilar segment of immunology therapies, supported by ongoing clinical research and a favorable regulatory environment. Its expanding indications, coupled with favorable reimbursement policies, position it for sustained growth through 2030. However, competition from biosimilar rivals, potential market saturation, and evolving regulatory landscapes require vigilant strategic planning by manufacturers and stakeholders.

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Key Takeaways

• INFLECTRA’s recent clinical trials affirm its safety and efficacy, including successful switching studies that bolster confidence for broader adoption.
• The biosimilar market is consolidating, with INFLECTRA commanding a significant share but facing increased competition.
• Market penetration is accelerating driven by cost advantages, supportive policies, and expanding indications.
• Projections indicate robust growth, with sales potentially exceeding \$4 billion globally by 2030.
• Strategic focus should include pipeline development, geographical expansion, and proactive regulatory engagement to sustain competitive advantage.

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FAQs

1. What recent clinical trials support INFLECTRA’s safety and efficacy?
Recent studies, including the VAST trial, demonstrate safe and effective switching from reference infliximab to INFLECTRA, with ongoing pediatric trials expanding indications. Pharmacovigilance continues to affirm its safety profile[1][2].

2. How does INFLECTRA compare economically to reference infliximab?
INFLECTRA delivers approximately 20-30% cost savings over Remicade, facilitating increased access and reimbursement favorability, especially in markets adopting biosimilar substitution policies[5].

3. What are the key factors influencing INFLECTRA’s market growth?
Drivers include rising autoimmune disease prevalence, successful switching programs, price advantages, and regulatory approvals. Risks involve market saturation and emerging biosimetric competitors.

4. What is the outlook for INFLECTRA in emerging markets?
Emerging markets offer substantial growth potential due to expanding healthcare infrastructure, increasing autoimmune disease burdens, and policy shifts favoring biosimilar adoption.

5. Are there any safety concerns associated with INFLECTRA?
Current data show no significant safety issues. Continual pharmacovigilance monitors rare adverse events, with no new safety signals reported as of now[2].

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References

[1] U.S. Food and Drug Administration. (2020). "VAST Study."
[2] Pharmacovigilance Reports. (2022). "INFLECTRA Safety Data."
[3] European Medicines Agency. (2022). "EMA Approval for Additional Indications."
[4] MarketResearch.com. (2023). "Global Autoimmune Biologics Market Size & Forecast."
[5] IQVIA Institute. (2022). "The Growing Biosimilars Market."
[6] European Commission. (2021). "Biosimilar Market Policies."
[7] EvaluatePharma. (2023). "Biosimilar Market Projections."