Renflexis vs Remicade – Are They Biosimilars?

Biosimilars are biologic medications designed to closely resemble their reference products in terms of safety, purity, and potency, but they often come at a lower cost. A recent market analysis found that biosimilars have captured 53% of their respective therapeutic segments and have reduced drug prices by approximately 53% within the first five years of launch. This shows how they are becoming an increasingly important part of the healthcare landscape.

When it comes to infliximab, two well-known options are Remicade (the original biologic) and Renflexis (infliximab-abda), which was approved by the FDA as a biosimilar in 2017. Both are used to treat chronic conditions like rheumatoid arthritis and Crohn’s disease, and they share the same mechanism of action. However, they differ in cost and market status.

In this article, we’ll compare Renflexis and Remicade. We will explore their efficacy, safety, interchangeability, and practical considerations to help you understand whether they truly function as biosimilars.

Key Takeaways

• Renflexis is a biosimilar to Remicade (infliximab) and is designed to closely match the molecular structure, target binding, and clinical outcomes of the reference biologic.
• Like Remicade, Renflexis delivers the same therapeutic benefits. Both treatments can target conditions like rheumatoid arthritis, Crohn’s disease, and psoriasis, providing a cost-effective alternative without compromising efficacy or safety.
• Renflexis is FDA-approved as a biosimilar to Remicade, but it is not considered interchangeable at the pharmacy level. This means supervised switching from Remicade to Renflexis is necessary to ensure proper monitoring and continuity of treatment.
• Switching from Remicade to Renflexis has been shown to have comparable outcomes in terms of disease control, with no significant increase in adverse events.
• Renflexis provides a more affordable option, typically priced 15–30% lower than Remicade. This price difference is a valuable choice for patients seeking cost relief and for healthcare systems aiming to reduce treatment expenses.
• Patient education and monitoring for immunogenicity and disease response are crucial when transitioning to Renflexis, ensuring that treatment remains effective and safe over time.

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Defining Biosimilarity: Why Renflexis Is Considered Equivalent to Remicade

Renflexis qualifies as a biosimilar to Remicade because it closely matches the molecular structure, target binding, and clinical outcomes of the reference biologic. To gain approval, biosimilars like Renflexis must demonstrate that they are highly similar to the original product without clinically meaningful differences in purity, potency, or safety. 

Regulatory agencies such as the FDA and EMA require extensive testing to confirm these similarities, ensuring that biosimilars meet the same standards of safety and effectiveness.

Key Criteria

• Molecular Comparability: Extensive testing confirms that Renflexis has a molecular structure nearly identical to Remicade, including aspects like protein folding, glycosylation patterns, and binding affinities.
  
• Pharmacokinetic and Pharmacodynamic Studies: Renflexis had to demonstrate that it behaves similarly to Remicade in the body. These studies looked at how the drug is absorbed, distributed, metabolized, and excreted, and showed that both drugs perform in nearly the same way.
  
• Immunogenicity Testing: Crucially, Renflexis was shown to have similar immunogenicity to Remicade, meaning it doesn’t trigger harmful antibodies when used for treatment, ensuring a smooth transition between the two therapies.

Clinical Trials and Approval

The regulatory approval of Renflexis involved clinical trials targeting inflammatory conditions like rheumatoid arthritis and Crohn’s disease. The trial results showed that Renflexis and Remicade are equally effective and safe, allowing Renflexis to be used for all of Remicade’s indications.

• Streamlined Approval Process: Thanks to these findings, the approval process for Renflexis was efficient, avoiding unnecessary redundant trials while still maintaining high safety and efficacy standards.
  
• Interchangeability: While Renflexis is recognized as a biosimilar to Remicade, it is not FDA-designated interchangeable. This means it can’t automatically be substituted for Remicade at the pharmacy level, and any switch requires healthcare provider oversight.

Efficacy and Safety Data: Renflexis vs Remicade Head-to-Head

Renflexis has been extensively studied in clinical trials and real-world settings, showing that it is clinically equivalent to Remicade in terms of efficacy and safety.

• In a head-to-head trial talking about Renflexis and Remicade for Crohn’s disease, clinical response rates were nearly identical at week 6. The results showed 71.4% for Renflexis versus 75.2% for Remicade, demonstrating non-inferiority.

Rheumatologic Extension Data

• Rheumatoid Arthritis: Long-term studies showed that Renflexis effectively suppressed disease progression and improved physical function without an increase in adverse events. It is important to note that the standard dose of Renflexis is 3 mg/kg in rheumatoid arthritis (when combining it with methotrexate). This dosage is slightly different from the 5 mg/kg dose for Crohn’s disease and other indications.
  
• Ankylosing Spondylitis: Patients who switched from Remicade to Renflexis maintained clinical response with no significant changes in safety, immunogenicity, or drug levels.
  
• Psoriatic Arthritis: Renflexis has shown consistent results in treating both skin and joint symptoms, especially since its approval in psoriatic arthritis was based on extrapolation from rheumatoid arthritis and ankylosing spondylitis studies.

These findings confirm Renflexis‘s role as a safe and effective treatment, similar to Remicade, across various chronic inflammatory conditions.

Formulation, Storage, and Administration: Are There Differences?

Although Renflexis (infliximab-abda) and Remicade (infliximab) share the same therapeutic goal and active ingredient, small differences exist in their formulation and administration protocols. Understanding these distinctions helps both clinicians and patients make informed decisions about treatment options. Here’s a detailed comparison:

Feature	Renflexis (infliximab-abda)	Remicade (infliximab)	Inflectra (infliximab-dyyb)
Active Ingredient	Infliximab-abda (biosimilar)	Infliximab (reference product)	Infliximab-dyyb (biosimilar)
Formulation Variations	Slight differences in excipients	Original formulation	Slightly different stabilizers/excipients
Administration Route	IV infusion
Dosing Schedule	5 mg/kg at weeks 0, 2, 6, then q8 weeks	5 mg/kg at weeks 0, 2, 6, then q8 weeks	5 mg/kg at weeks 0, 2, 6, then q8 weeks
Storage Requirements	Refrigerated (2–8°C), protect from light	Refrigerated (2–8°C), protect from light	Refrigerated (2–8°C), protect from light
Infusion Duration	~2 hours, with vital sign monitoring	~2 hours, with vital sign monitoring	~2 hours, with vital sign monitoring
Regulatory Status	FDA-approved biosimilar	FDA-approved reference product	FDA-approved biosimilar
Cost and Access	10–30% less expensive than Remicade	Typically more costly	Competitive pricing varies by provider

In clinical practice, it is important for providers to understand these nuanced distinctions between Remicade, Renflexis, and other biosimilars, as they help tailor treatment plans without compromising patient outcomes. All three options deliver consistent efficacy and safety, allowing for personalized treatment based on availability, insurance coverage, and other factors.

Switching to Renflexis from Remicade: Clinical and Cost Considerations

Switching from Remicade to Renflexis is typically straightforward, as both share the same active ingredient, infliximab. Clinical studies and real-world data have shown that switching between these biologics does not result in a loss of therapeutic benefit or increased adverse events.

• Switching Protocols: Studies confirm that supervised switching between Remicade and Renflexis preserves disease control and minimizes the risk of side effects.
  
• Cost Efficiency: One of the main reasons Renflexis is gaining popularity is its lower cost, typically 15–30% less than Remicade, making it more accessible, especially for patients who are paying out-of-pocket or in public health systems.
  
• Monitoring After Switching: Patients who switch from Remicade to Renflexis generally report no difference in side effects or disease control. Providers may perform tests, such as trough levels or antibody screening, during the initial post-switch phase to ensure continued effectiveness.

Conclusion

Renflexis offers a safe, effective, and cost-effective alternative to Remicade for treating conditions like Crohn’s disease, rheumatoid arthritis, and psoriasis. While both biologics are similar in their therapeutic benefits, Renflexis offers a more affordable solution without compromising efficacy or safety. The decision between Renflexis vs Remicade often comes down to cost, formulary preferences, and the healthcare provider’s experience with switching protocols.

When managed carefully and monitored for immunogenicity and disease response, Renflexis can be a reliable option for patients seeking long-term disease control with added economic benefit.

FAQs

1. Are Renflexis and Remicade the same?

No, but they share identical active components and according to experts, they have no clinically meaningful differences in effectiveness or safety.

2. Can I switch from Remicade to Renflexis?

Yes. Clinical studies support switching under supervision, and most insurers now cover Renflexis after discussion with the prescribing physician.

3. Will I need more monitoring after switching to Renflexis?

Patients won’t need extra monitoring if they make the switch. Standard therapeutic drug monitoring protocols apply equally to both biologics.

4. Is Renflexis cheaper than Remicade?

Typically, yes. Renflexis is often 10–30% less expensive, which supports better access for patients and reduces healthcare expenditures.

References

Steedman S, Giang J. Outcomes of the use of infliximab biosimilars in rheumatology and gastroenterology clinics. J Manag Care Spec Pharm. 2024;30(1):22-25. doi:10.18553/jmcp.2024.30.1.22

Jeremias S. Biosimilars drive cost savings and achieve a 53% market share across treatment areas. Center for Biosimilars website. Published January 16, 2025. https://www.centerforbiosimilars.com/view/biosimilars-drive-cost-savings-and-achieve-53-market-share-across-treatment-areas