Skip to content

What Type of Drug Is Yuflyma? A Guide to the Humira Biosimilar

2 min read

As of 2024, Humira® biosimilars have captured approximately 23% of the adalimumab market. An important drug in this class is Yuflyma. So, what type of drug is Yuflyma? It is an interchangeable biosimilar to Humira and belongs to a class of drugs called Tumor Necrosis Factor (TNF) alfa inhibitors.

Quick Summary

Yuflyma (adalimumab-aaty) is an injectable prescription medicine classified as a TNF blocker. It's an FDA-approved interchangeable biosimilar to Humira, used to treat various inflammatory autoimmune conditions.

Key Points

  • Drug Class: Yuflyma is a Tumor Necrosis Factor (TNF) alfa inhibitor, a type of biologic drug.

  • Biosimilar to Humira: It is an FDA-approved interchangeable biosimilar for the reference product, Humira (adalimumab).

  • Mechanism of Action: It works by blocking TNF, a protein that causes inflammation in various autoimmune diseases.

  • Indications: Yuflyma treats multiple conditions. See {Link: Drugs.com https://www.drugs.com/yuflyma.html} for a list of conditions.

  • Formulation: It is a high-concentration, citrate-free formula, designed to reduce injection volume and pain.

  • Administration: The drug is self-administered as a subcutaneous injection via a prefilled syringe or auto-injector.

  • Important Warnings: Yuflyma has a boxed warning for increased risk of serious infections and malignancies.

In This Article

Understanding Yuflyma (adalimumab-aaty)

Yuflyma, with the generic name adalimumab-aaty, is an FDA-approved biologic medication in the class of Tumor Necrosis Factor (TNF) alfa inhibitors. It is used to reduce pain, inflammation, and skin symptoms associated with various autoimmune conditions. It is given as a subcutaneous injection and patients can learn to self-inject.

Yuflyma is an "interchangeable biosimilar" to Humira (adalimumab). This means it is highly similar to Humira with no clinically meaningful differences and, depending on state law, may be substituted by a pharmacist for a Humira prescription without a doctor's approval.

How Yuflyma Works

Yuflyma targets and blocks TNF-alpha, a protein that promotes inflammation in autoimmune disorders where the immune system attacks the body's tissues. By neutralizing TNF, Yuflyma helps reduce inflammation and symptoms.

Approved Uses for Yuflyma

Yuflyma is FDA-approved for several inflammatory conditions in specific patient groups. A comprehensive list of approved uses can be found on {Link: Drugs.com https://www.drugs.com/yuflyma.html}.

Key Features of Yuflyma

Yuflyma is a high-concentration (100mg/mL), citrate-free formulation. It can be stored at room temperature (up to 77°F or 25°C) for up to 30 days.

Comparison: Yuflyma vs. Humira

Yuflyma is designed to have the same clinical outcome as Humira. Key differences and similarities include:

Feature Yuflyma (adalimumab-aaty) Humira (adalimumab)
Drug Class TNF alfa inhibitor TNF alfa inhibitor
Active Ingredient Adalimumab-aaty Adalimumab
FDA Approval (Initial) May 23, 2023 December 31, 2002
Interchangeable? Yes, for all approved dosage forms and strengths Reference Product
Formulation High-concentration (100mg/mL), citrate-free Available in both original and high-concentration, citrate-free forms.
Administration Subcutaneous injection (prefilled syringe & auto-injector) Subcutaneous injection (prefilled syringe & auto-injector)
Indications Approved for 9 inflammatory conditions Approved for the same core inflammatory conditions

Important Safety Information and Side Effects

BOXED WARNING: SERIOUS INFECTIONS AND MALIGNANCY Like other TNF blockers, Yuflyma carries a boxed warning about increased risk of serious infections and malignancies. Patients should be tested for latent TB before starting treatment.

Common Side Effects

Common side effects (over 10% of users) include infections (like upper respiratory infections), injection site reactions, headache, and rash.

Serious Side Effects

Seek immediate medical attention for signs of serious infection, lymphoma, heart failure, liver problems, or nerve issues. Discuss medical history, including cancer, heart failure, hepatitis B, or upcoming surgery/vaccines, with a healthcare provider.

Conclusion

Yuflyma (adalimumab-aaty), a TNF blocker and interchangeable biosimilar to Humira, offers a clinically equivalent treatment option for various autoimmune diseases. Its high-concentration, citrate-free formulation aims to improve the patient experience. Patients should discuss the benefits and risks with their doctor before starting Yuflyma.


Authoritative Link: For more detailed prescribing information, you can visit the {Link: FDA's drug database entry for Yuflyma https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761219s000lbl.pdf}.

Frequently Asked Questions

Yuflyma (adalimumab-aaty) is a biologic medication that belongs to the drug class of TNF alfa inhibitors. It is also an FDA-approved interchangeable biosimilar to Humira.

An interchangeable biosimilar is a biologic product that is not only highly similar to an existing FDA-approved biologic (the 'reference product') but is also expected to produce the same clinical result. This means a pharmacist may substitute it for the reference product without needing to consult the prescriber, state laws permitting.

Yuflyma is FDA-approved to treat several inflammatory conditions. A full list can be found at {Link: Drugs.com https://www.drugs.com/yuflyma.html}.

Yuflyma is administered as an injection under the skin (subcutaneous), typically in the thigh or abdomen. It is available in a prefilled auto-injector and prefilled syringe for patients to use at home after proper training.

Yuflyma is an interchangeable biosimilar to Humira, meaning no clinically meaningful differences exist in safety and effectiveness. Yuflyma's high-concentration, citrate-free formula may lead to less injection pain, and it can be substituted by a pharmacist.

Common side effects include infections (like upper respiratory), injection site reactions, headache, and rash.

Yuflyma should be refrigerated, but can be stored at room temperature (up to 77°F or 25°C) for up to 30 days, protected from light. It must be discarded if not used within 30 days.

References

  1. 1
  2. 2
  3. 3
  4. 4
  5. 5
  6. 6
  7. 7
  8. 8
  9. 9
  10. 10

Medical Disclaimer

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