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
NCT02539368 ↗	Post-Marketing Use Of CT-P13 (Infliximab) For Standard Of Care Treatment Of Inflammatory Bowel Disease	Completed	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.
NCT02517684 ↗	Top-down Infliximab Study in Kids With Crohn's Disease	Active, not recruiting	ZonMw: The Netherlands Organisation for Health Research and Development	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
Ulcerative Colitis	1
Biologic; Inadequate	1

Condition MeSH

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

Clinical Trial Locations for INFLECTRA

Trials by Country

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

INFLECTRA Market Analysis and Financial Projection

Last updated: February 4, 2026

What is the current status of INFLECTRA's clinical trials?

INFLECTRA (infliximab-dyyb) is a biosimilar to Remicade (infliximab) developed by Pfizer. Its clinical development primarily focused on indications such as rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis. As of the latest updates, INFLECTRA has completed Phase 3 trials in multiple indications, supporting its approval in various markets.

Key highlights:

• Approved markets include the US, EU, Canada, Japan, and Australia. Regulatory agencies have approved INFLECTRA based on comparability to Remicade, supported by clinical data demonstrating similar efficacy and safety profiles.

• Clinical trial scope involved over 1,000 patients across different indications, primarily focusing on equivalence trials for efficacy, safety, and immunogenicity.

• Ongoing studies include real-world safety and effectiveness evaluations, post-marketing surveillance, and biosimilarity confirmatory studies in additional autoimmune conditions.

Regulatory milestones:

Date	Authority	Approval Status	Indications
March 2016	FDA	Approved	Rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis
July 2016	EMA	Approved	Same indications as FDA, with additional post-approval commitments
Other regions	Regulatory submissions pending/approved	Varies	Brazil, Japan, Australia

What is the market landscape for INFLECTRA?

INFLECTRA faces competition primarily from other biosimilars and the reference biologic Remicade. The biosimilar market has expanded rapidly due to patent expirations and increasing adoption of cost-effective alternatives.

Market size and growth:

• The global biosimilar market was valued at approximately USD 18.7 billion in 2021 and is projected to compound annually at around 23% until 2027.[1]
• Infliximab biosimilars, including INFLECTRA, account for a significant portion of this growth, with global sales estimated at USD 2.5 billion in 2022.[2]
• US sales of INFLECTRA in that year totaled approximately USD 700 million, representing about 28% of global biosimilar infliximab sales.[3]

Competitive landscape:

Biosimilar	Market Launch Date	Main Competitors	Market Share (US, 2022)
INFLECTRA	2016	Remicade, Renflexis	28%
Flixabi	2017	Remicade, Inflectra	15%
Renflexis	2017	Remicade	12%
Other biosimilars	2018–present	Multiple	45% combined

Pricing and reimbursement: INFLECTRA's prices are approximately 30-50% lower than the reference Remicade, depending on the region. Payers increasingly favor biosimilars due to cost savings, leading to formulary shifts favoring INFLECTRA.

What are the projections for INFLECTRA’s future market growth?

The outlook for INFLECTRA is optimistic, driven by patent expirations of Remicade and increasing biosimilar adoption.

Forecasts:

• Sales are expected to grow at a CAGR of approximately 20% between 2022 and 2027, reaching USD 1.5 billion globally.
• The North American market will dominate, accounting for about 50% of sales, followed by Europe with 30%, Asia-Pacific with 15%, and the rest of the world with 5%.

Key drivers:

• Expanding approvals in additional indications such as hidradenitis suppurativa and juvenile arthritis.
• Growth in biosimilar acceptance in emerging markets with cost-sensitive healthcare systems.
• Ongoing negotiations with payers to include INFLECTRA in preferred formularies.
• Competitive biosimilar launches from competitors, which could moderate growth.

Risks:

• Patent litigations and legal challenges in certain regions.
• Regulatory hurdles for new indications.
• Market saturation in mature markets.

What strategic considerations should stakeholders evaluate regarding INFLECTRA?

• Patent landscape: Pfizer’s patent challenges in key markets could impact future sales.
• Market expansion: Focus on gaining approval in additional therapeutic areas, especially in emerging markets.
• Pricing strategies: Maintaining competitive pricing to sustain market share amidst emerging biosimilars.
• Post-marketing surveillance: Ensuring continued safety and efficacy data to support market confidence and regulatory status.
• Partnerships: Collaborations with healthcare providers and payers to optimize formulary positioning and adoption.

Key Takeaways

• INFLECTRA's clinical development is complete across major autoimmune indications, with global approvals since 2016.
• The biosimilar market is expanding rapidly, with INFLECTRA capturing significant share due to price advantages.
• Sales are projected to increase markedly over the next five years, driven by patent expirations and expanding indication approvals.
• Competitive pressures from new biosimilars and legal challenges remain key risks.
• Market success hinges on regulatory strategy, pricing, and post-marketing data support.

FAQs

1. How does INFLECTRA compare to the original biologic Remicade?
INFLECTRA demonstrates similar efficacy, safety, and immunogenicity profiles in clinical trials, leading regulators to approve it as a biosimilar.

2. What are the primary markets for INFLECTRA?
The US, Europe, Canada, Japan, and Australia represent the largest markets, with emerging markets also offering growth opportunities.

3. What indications are currently approved for INFLECTRA?
Rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis.

4. How is INFLECTRA impacting healthcare costs?
It offers a 30-50% lower price point than Remicade, leading to substantial cost savings and increased access to treatment.

5. What are the main risks to INFLECTRA’s market position?
Legal patent disputes, entry of new biosimilars, regulatory delays, and market saturation.

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Sources:

[1] Grand View Research. "Biosimilar Market Size, Share & Trends," 2022.
[2] EvaluatePharma. "Worldwide Infliximab Biosimilar Sales," 2022.
[3] Pfizer Investor Reports. "INFLECTRA (Infliximab-dyyb) US Sales Data," 2022.