Celltrion Expands YUFLYMA® Availability with New Interchangeability Status

Celltrion's YUFLYMA® Achieves FDA Interchangeability Designation

YUFLYMA (adalimumab-aaty) is an innovative biosimilar developed by Celltrion, renowned for its high-concentration (100mg/mL) and citrate-free formulation designed to mirror the original Humira (adalimumab).

Expanded Interchangeability for YUFLYMA®

Celltrion has been granted an expanded interchangeability designation for YUFLYMA (adalimumab-aaty) by the U.S. Food and Drug Administration (FDA). This notable advancement now includes the prefilled syringe (40mg) and autoinjector presentations (40mg and 80mg) along with the existing prefilled syringe options of 20mg and 80mg.

What This Means for Patients

With this new designation, YUFLYMA is recognized as fully interchangeable with Humira across all marketed dosage forms and strengths, enhancing treatment accessibility for patients needing adalimumab-based therapies.

Increased Accessibility and Pricing Strategy

To support patient access and affordability, Celltrion has also implemented a strategic price reduction for YUFLYMA. The wholesale acquisition cost (WAC) has been lowered to $948 per syringe, effective immediately. This aligns with governmental initiatives to reduce drug costs, ensuring patients receive high-quality treatment at more manageable prices.

Clinical Efficacy and Safety

The interchangeability of YUFLYMA is backed by results from a Phase III interchangeability study involving patients with moderate to severe plaque psoriasis. The study assessed the pharmacokinetics, efficacy, safety, and immunogenicity of patients receiving either the reference adalimumab or alternating between YUFLYMA and the reference product. These outcomes demonstrated similar performance across treatment groups.

Broad Range of Indications

YUFLYMA is approved for the treatment of several inflammatory conditions, including rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), ulcerative colitis (UC), plaque psoriasis (Ps), hidradenitis suppurativa, and uveitis. It is also effective for treating Crohn's disease in adults and pediatric patients aged six and older, as well as juvenile idiopathic arthritis (JIA) in patients aged two and older.

About Celltrion

Celltrion, Inc. is a leading biopharmaceutical company engaged in the research, development, manufacturing, and marketing of innovative therapeutics worldwide. As a pioneer in the biosimilar field, Celltrion has launched the first monoclonal antibody biosimilar, emphasizing its commitment to enhancing patient care in multiple therapeutic areas, including immunology, oncology, and endocrinology.

Ongoing Commitment to Innovation

Celltrion remains dedicated to advancing its pipeline of novel drugs while ensuring broad accessibility for patients. The company’s robust portfolio of biologics and competitive pricing strategies reflects its aim to meet diverse patient needs while continuing to push the limits of scientific innovation.

Frequently Asked Questions

What is YUFLYMA®?

YUFLYMA® (adalimumab-aaty) is a biosimilar to Humira, used for treating inflammatory conditions such as RA, psoriasis, and Crohn's disease.

Why is the interchangeability designation important?

The interchangeability designation allows pharmacists to substitute YUFLYMA for Humira, improving patient access to treatment options without compromising quality.

How has pricing changed for YUFLYMA®?

The wholesale acquisition cost for YUFLYMA has been reduced to $948 per syringe, promoting affordability and patient access.

What are the indications for YUFLYMA?

YUFLYMA is indicated for several inflammatory diseases, including RA, JIA, PsA, and ulcerative colitis, among others.

Who is Celltrion?

Celltrion, Inc. is a biopharmaceutical company specializing in developing and producing innovative biological treatments, focusing on biosimilars and novel therapeutics.

About The Author

Hi there, As a writer and financial specialist, Henry Turner is passionate about guiding people through the complex world of finance. Having worked in finance for many years, I am an expert at simplifying difficult financial ideas into understandable, useful insights for my blog and articles. My goal is to arm you with the confidence and information you need to make wise financial choices.

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