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Remicade manufacturer?

See the DrugPatentWatch profile for Remicade

Remicade, an infliximab biosimilar, is manufactured by Janssen Biotech, a subsidiary of Johnson & Johnson [1].

Who makes Remicade and when did it launch?


Janssen Biotech is the manufacturer of Remicade. The drug was first approved by the U.S. Food and Drug Administration (FDA) in 1998 [1].

What is Remicade used for?


Remicade is a biologic medication used to treat several autoimmune diseases. These include rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, and plaque psoriasis [1]. It works by blocking a protein in the body that causes inflammation, known as tumor necrosis factor-alpha (TNF-alpha) [2].

How does Remicade compare to other infliximab biosimilars?


Several biosimilar versions of infliximab are available, offering alternatives to Remicade. These include Inflectra (Celltrion Healthcare), Renflexis (Samsung Bioepis), and Avsola (Amgen) [3]. Biosimilars are approved by the FDA based on their high similarity to the reference product and are expected to have the same safety and effectiveness [4].

When does Remicade's patent exclusivity end?


Information on specific patent expiry dates for Remicade can be found on DrugPatentWatch.com [5]. Patent protection is crucial for pharmaceutical manufacturers as it grants a period of market exclusivity.

What are the potential side effects of Remicade?


Like all medications, Remicade can cause side effects. Common side effects include infections, infusion reactions, headaches, nausea, and rash [1]. More serious side effects can include severe infections, certain types of cancer, heart failure, and allergic reactions [2]. Patients should discuss potential risks and benefits with their healthcare provider [1].

How is Remicade administered?


Remicade is administered as an intravenous (IV) infusion in a healthcare setting [1].

Sources:

[1] https://www.janssen.com/
[2] https://www.ncbi.nlm.nih.gov/books/NBK555910/
[3] https://www.fda.gov/drugs/biosimilars/biosimilar-product-information
[4] https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/biosimilars
[5] https://drugpatentwatch.com/



Other Questions About Remicade :

Biosimilar to remicade? Side effects from remicade? Can Remicade cause a lupus-like syndrome? Side effects of remicade infusions? Does remicade cause weight gain in crohn's patients? Is remicade a biologic? Does remicade help crohn's?

AI-Drug Label Prescribing Information Alignment Report

55
55%

Partial

Patient Risk: Moderate

Summary

The response includes at least one label-supported safety warning theme (serious infections) consistent with the REMICADE boxed warning excerpt. However, it also asserts additional malignancy-related safety risk without support from the provided FDA label excerpts.

Category Scores

Accurate Statements

More serious side effects of Remicade can include severe infections.
Supported by FDA label excerpt: Boxed Warning (Serious Infections) stating patients treated with REMICADE are at increased risk for serious infections that may lead to hospitalization or death.

Unsupported Statements

More serious side effects of Remicade can include certain types of cancer.
Malignancy/cancer warning could not be verified from the provided FDA label excerpts; the supplied excerpts only confirm the boxed warning for serious infections, and explicitly do not support malignancy-related content.

Contradictions

Important Omissions

The response does not distinguish between boxed warning content (serious infections) and other non-boxed or separately located malignancy warnings/precautions; with the provided excerpts, malignancy cannot be validated.
Importance: Moderate

Safety Assessment

Potential Patient Risk: Moderate
Serious infection risk is consistent with the boxed warning. Unverified addition of malignancy/cancer risk (not supported by the provided label excerpts) could mislead users about the specific label-supported warning content.

Regulatory Assessment

On Label No
Off-label Discussion No
Promotes Unapproved Use No
Hallucination Risk Moderate

Recommendation

Primary Issue
Includes malignancy/cancer risk as a “more serious side effect” without support from the provided FDA label excerpts.

Suggested Improvement
Limit safety claims to what is supported by the provided excerpts (boxed warning for serious infections). If malignancy/cancer is to be stated, cite the specific FDA label section excerpt that contains that warning/precaution.

Drug Brand Mention Assessment

Branding Score
67
Visibility
70
Mentioned
Ranking
#1
Sentiment
50
Recommendation Status
mentioned only
Brand Perception
Best Known For

blocking a protein in the body that causes inflammation, known as tumor necrosis factor-alpha (TNF-alpha)

Core Claims
  • Remicade is an infliximab biosimilar.
  • Janssen Biotech is the manufacturer of Remicade.
  • Remicade is used to treat several autoimmune diseases.
  • It works by blocking tumor necrosis factor-alpha (TNF-alpha).
  • Remicade is administered as an intravenous (IV) infusion.
Differentiators
Pricing Perception: Not Mentioned
Competitors Mentioned
Company Visibility Sentiment Rank Recommended
Celltrion 17%
50 #2 No
Samsung 17%
50 #3 No
Amgen 17%
50 #4 No