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How is Avsola different from Remicade? A Detailed Comparison

2 min read

Approximately 8% of the U.S. population lives with an autoimmune disease, many of whom rely on biologic medications. This article explores the question: How is Avsola different from Remicade?, clarifying their relationship as a biosimilar and its reference product.

Quick Summary

Avsola is a biosimilar to Remicade, meaning it is highly similar in safety and efficacy, has the same active ingredient, and treats the same conditions. The primary difference is that Avsola is a more cost-effective option.

Key Points

  • Core Identity: Avsola is a biosimilar to Remicade, not a generic, meaning it is highly similar with no clinically meaningful differences in efficacy or safety.

  • Active Ingredient: Both Avsola and Remicade share the same active ingredient, infliximab, and work by blocking TNF-alpha to reduce inflammation.

  • Approved Uses: Avsola is FDA-approved to treat all the same autoimmune conditions as Remicade, including Crohn's disease, rheumatoid arthritis, and ulcerative colitis.

  • Primary Difference: The most significant distinction is cost; biosimilars like Avsola are typically less expensive than their reference biologic, Remicade.

  • Interchangeability: Avsola is not an 'interchangeable' biosimilar, meaning a doctor must specifically prescribe it; it cannot be automatically substituted by a pharmacist.

  • Administration: Both drugs are administered in the same way, through an intravenous (IV) infusion, with dosing based on weight and condition.

  • Safety Profile: Both medications have similar side effect profiles and carry the same FDA boxed warnings for risks like serious infections.

In This Article

Understanding Remicade and the Rise of Biologics

Remicade (infliximab) is a biologic medication approved by the FDA in 1998. It's a TNF-alpha blocker, targeting a protein that causes inflammation in autoimmune diseases. By binding to TNF-alpha, infliximab reduces inflammation and symptoms of several conditions. Biologics are complex drugs made from living organisms and cannot have exact generic copies. Instead, when patents expire, biosimilars can be developed.

What is Avsola? The Concept of Biosimilarity

Avsola (infliximab-axxq) received FDA approval in 2019 as a biosimilar to Remicade. Biosimilars are highly similar to their reference product with no clinically meaningful differences in safety, purity, and potency. Amgen demonstrated Avsola's equivalence to Remicade through extensive testing, including a clinical study in rheumatoid arthritis patients. Biosimilars have the same active ingredient, mechanism, dosage, and strength, are approved for the same conditions, and provide a more affordable alternative.

Head-to-Head: Avsola vs. Remicade

Avsola and Remicade have no clinically meaningful differences, according to the FDA. Both are administered intravenously.

Key Similarities

  • Active Ingredient: Both use infliximab.
  • Mechanism of Action: Both block TNF-alpha to reduce inflammation.
  • Approved Indications: Avsola is approved for the same conditions as Remicade, including various forms of arthritis, Crohn's, and ulcerative colitis.
  • Efficacy and Safety: Clinical trials show Avsola is as safe and effective as Remicade, with similar side effects and boxed warnings.
  • Dosage and Administration: Both are given via IV infusion, with dosing based on weight and condition.

The Main Differences

  1. Cost: Avsola is generally less expensive than Remicade, offering potential savings. One source noted Avsola's price as more than 50% cheaper.
  2. Manufacturer: Remicade is made by Janssen Biotech, while Avsola is by Amgen.
  3. Naming: Avsola is infliximab-axxq to distinguish it from Remicade (infliximab) and other biosimilars like Inflectra (infliximab-dyyb).
  4. Interchangeability: Avsola is a biosimilar but not designated as "interchangeable," meaning a specific prescription is required; a pharmacist cannot substitute it for Remicade without a doctor's order.

Comparison Table: Avsola vs. Remicade

Feature Avsola (infliximab-axxq) Remicade (infliximab)
Product Type Biosimilar Reference Biologic
Manufacturer Amgen Janssen Biotech, Inc.
FDA Approval Year 2019 1998
Active Ingredient infliximab infliximab
Mechanism of Action TNF-alpha inhibitor TNF-alpha inhibitor
Indications Same as Remicade RA, Crohn's, UC, PsA, AS, Plaque Psoriasis
Efficacy & Safety No clinically meaningful differences from Remicade Established through decades of use
Cost Generally lower Higher
Interchangeable No Not Applicable

Conclusion: Choosing Between Avsola and Remicade

Biosimilars like Avsola increase access to biologic treatments. The main practical differences for patients and providers are cost and insurance coverage. Since they are clinically similar, the choice often depends on financial factors and insurance plan preferences. Patients considering a switch should consult their healthcare provider for a specific prescription. Avsola offers a safe, effective, and lower-cost option with the same benefits as Remicade for chronic autoimmune diseases.

For more information from the manufacturer, visit https://www.avsola.com.

Frequently Asked Questions

No, Avsola is not a generic. It is a 'biosimilar.' Biologic drugs are too complex to be copied exactly like chemical drugs. A biosimilar is a highly similar version with no clinically meaningful differences in safety or effectiveness from the original biologic (Remicade).

The main difference is cost. As a biosimilar, Avsola is generally offered at a lower price than Remicade. Clinically, the FDA has determined there are no meaningful differences in their safety or efficacy.

Yes, because they are clinically equivalent and share the same active ingredient, Avsola and Remicade have similar side effect profiles and carry the same boxed warnings from the FDA.

Yes, but you must consult your healthcare provider. Because Avsola is not designated as 'interchangeable,' your doctor must write a new prescription specifically for Avsola. A pharmacist cannot automatically substitute it for a Remicade prescription.

Yes. To gain FDA approval, Avsola underwent rigorous testing and clinical trials to prove it is as safe and effective as Remicade, with no clinically meaningful differences in outcomes.

The four-letter suffix, like '-axxq', is required by the FDA for biosimilars to distinguish them from the reference product and other biosimilars. This system helps with accurate tracking and pharmacovigilance.

Insurance coverage for Avsola can vary. Many insurance plans cover biosimilars and may even prefer them due to the lower cost. It is best to contact your health insurance plan directly for specific coverage details.

References

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Medical Disclaimer

This content is for informational purposes only and should not replace professional medical advice.