Remicade Manufacturer – Janssen Biotech, Inc

David Fuller

Last Updated On: July 8, 2025

As one of the most widely prescribed biologic treatments for autoimmune diseases, Remicade (infliximab) is a critical medication in the fight against conditions like rheumatoid arthritis, Crohn’s disease, and psoriasis.

Manufactured by Janssen Biotech, Inc., a subsidiary of Johnson & Johnson, Remicade has become a cornerstone of biologic therapy. Janssen, initially known as Centocor, was instrumental in pioneering the development of anti-TNF therapies, which have revolutionized the treatment of chronic inflammatory diseases.

In this article, we’ll delve into Janssen Biotech’s pivotal role in producing Remicade, focusing on their rigorous manufacturing standards, global distribution capabilities, and what distinguishes them in the biologics sector. 

Key Takeaways

• Remicade was approved by the FDA in 1998, becoming one of the first monoclonal antibody therapies for autoimmune diseases. 
• It is developed by Janssen Biotech, Inc. as a key treatment for conditions like rheumatoid arthritis and Crohn’s disease.
• Janssen ensures high-quality production through advanced bioreactor technology, rigorous quality testing, and cold-chain distribution systems, maintaining consistency and effectiveness in Remicade dosing.
• In the U.S., Janssen handles Remicade’s manufacturing and distribution, while Merck & Co. oversees its distribution in Europe and other regions.
• Following the patent expiry in 2015 (Europe) and 2018 (U.S.), biosimilars like Inflectra and Renflexis were introduced as affordable alternatives to Remicade.
• Despite the availability of biosimilars, Janssen remains trusted by healthcare providers for its quality control, clinical research, and consistent product availability.
• Janssen offers patient assistance programs, financial support, and education to help patients with Remicade therapy, ensuring better patient adherence and treatment outcomes.

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A Look at Janssen’s Role in Remicade’s History

Remicade, approved by the FDA in 1998, marked a significant milestone in biologic therapy, becoming one of the first monoclonal antibodies (mAbs) for treating chronic inflammatory diseases. Developed by Janssen Biotech, Inc., formerly known as Centocor, Remicade paved the way for anti-TNF therapy. 

Over the years, Janssen’s research investments in large-scale clinical trials demonstrated the efficacy of infliximab, leading to its adoption for a wide range of conditions, including rheumatoid arthritis, Crohn’s disease, and psoriasis. The company’s deep commitment to clinical studies helped build a foundation for modern biologic development.

Through its partnership with Johnson & Johnson, Janssen expanded Remicade’s global footprint, gaining approvals in more than 100 countries. Its role in anti-TNF therapy was solidified, influencing the treatment landscape for autoimmune conditions. Janssen’s leadership in the biopharmaceutical field continues to ensure Remicade’s position as a trusted therapeutic option.

How Janssen Maintains Quality in Remicade Production

Manufacturing biologic therapies like Remicade requires a far more complex process than traditional drug production. Janssen has established rigorous manufacturing standards to ensure every batch of infliximab maintains its potency and safety. These standards include:

• Advanced bioreactor technology to ensure product purity and consistency.
  
• Extensive quality control testing performed at various production stages.
  
• Use of cold-chain distribution systems to preserve the stability of the drug during transport.
  
• Adherence to Good Manufacturing Practices (GMP), both domestically and internationally, ensuring compliance with regulatory bodies.
  
• Post-marketing surveillance to monitor safety and assess long-term treatment outcomes.

These comprehensive quality measures ensure that Remicade continues to provide effective treatment while maintaining high safety standards. This level of care is crucial when considering Remicade dosing, as even slight inconsistencies could affect therapeutic outcomes.

Global Distribution and Licensing of Remicade

Remicade’s global distribution is powered by Janssen’s partnership model, which includes both Janssen-led operations and licensed partnerships. In the United States, Janssen Biotech handles the production and sales, while in Europe and other regions, the company licensed Remicade to Merck & Co. for wider access. These strategic partnerships helped bring Remicade to markets worldwide, ensuring patients received a consistent formulation.

Janssen operates several certified manufacturing facilities across the U.S., Europe, and Asia. Each site adheres to stringent regulatory oversight, ensuring that infliximab is available to patients with reliable quality. Remicade dosing schedules across various regions remain consistent, thanks to Janssen’s global distribution network and logistical expertise.

Patent Expiry and the Rise of Biosimilars After Remicade

Remicade’s foundational patents began to expire in Europe in February 2015 and in the United States in September 2018 following litigation and the Patent and Trademark Office (PTO) appeal. This paved the way for the introduction of biosimilars, such as Inflectra, Renflexis, and Avsola. While these biosimilars offer a more affordable alternative to Remicade, they are produced by different manufacturers and undergo their own unique production processes.

Biosimilars are not identical to Remicade, but they share similar active molecules and clinical effectiveness. Patients and healthcare providers must be aware of what to avoid while on Remicade and its biosimilars, especially when switching between brands. While biosimilars are thoroughly tested, some providers may still prefer the original Remicade product due to its long-standing safety profile and Janssen’s transparency.

Why the Manufacturer Still Matters to Prescribers

Despite the availability of biosimilars, Janssen’s name remains influential in the biologic market. Manufacturer reliability affects everything from pharmacovigilance to drug availability and patient support services. For prescribers, Janssen’s commitment to high-quality production, extensive clinical data, and ongoing patient assistance programs helps maintain trust in their products.

Janssen’s dedication to GMP standards ensures that each vial of Remicade is consistent, which is crucial for both the efficacy and safety of the treatment. Healthcare providers can feel confident that Remicade dosing will remain reliable, as Janssen’s commitment to product quality reduces the risk of variations in therapeutic response.

Conclusion

Janssen Biotech, Inc. has played a pivotal role in shaping Remicade’s success, from its introduction as one of the first anti-TNF monoclonal antibodies to its global expansion. Through rigorous manufacturing practices and a commitment to long-term research, Janssen continues to ensure Remicade’s position as a cornerstone in autoimmune disease therapy. 

Even with the rise of biosimilars, Janssen’s dedication to patient support and regulatory compliance remains unmatched, making the company a trusted partner in patient care.

FAQs

1. Who manufactures Remicade?

Janssen Biotech, Inc., a subsidiary of Johnson & Johnson, manufactures Remicade. They oversee production, quality control, and distribution in the U.S. and many global markets.

2. Is Remicade still available now that biosimilars exist?

Yes, the original Remicade is still available, alongside biosimilars such as Inflectra and Renflexis. Many providers continue to prescribe it based on familiarity, trust in the manufacturer, and clinical history.

3. Does the manufacturer impact Remicade dosing?

While dosing guidelines are standardized, manufacturer consistency can influence tolerability and response. That’s why many clinicians prefer sticking with trusted brands for biologic therapies.

4. Are there safety differences between Remicade and its biosimilars?

All biosimilars must meet FDA safety standards. However, slight variations in manufacturing can affect how patients respond. It’s essential to understand what to avoid while on Remicade or any biosimilar version to stay safe during treatment.

References

Lee N, Rhee S, Koo SM, et al. Navigating Recent changes in dosing information: Dynamics of FDA‐Approved Monoclonal Antibodies in Post‐Marketing Realities. Clinical and Translational Science. 2025;18(1). doi:10.1111/cts.70125

U.S. Food and Drug Administration. Remicade (infliximab) [prescribing information]. FDA website. Revised October 2021. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103772s5401lbl.pdf