Celltrion Healthcare introduces a biosimilar version of Humira called Yuflyma, in the US

Celltrion Healthcare, a biopharmaceutical company based in South Korea, has announced the introduction of Yuflyma, a biosimilar product, in the United States. Yuflyma is a citrate-free and high-concentration formulation of Humira, a widely used treatment for autoimmune diseases like rheumatoid arthritis, psoriasis, Crohn’s disease, and ulcerative colitis. This new biosimilar provides patients with an alternative option for managing their conditions effectively.

Following its approval by the Food and Drug Administration (FDA) on May 23, 2023, Yuflyma has become commercially available in the U.S. through major distributors starting from July 2nd. It is offered at a monthly price of $6,576.50 and is available in two convenient forms: auto-injectors and pre-filled syringes. Since over 80% of Humira patients in the U.S. rely on a high-concentration and citrate-free formulation, Yuflyma serves as a suitable alternative for them.

One notable advantage of Yuflyma is its citrate-free formulation, which reduces discomfort during injections, leading to improved treatment adherence, especially for individuals with chronic conditions like rheumatoid arthritis. Furthermore, Yuflyma has a longer shelf life compared to Humira, remaining stable at 25℃ (77°F) for 30 days. Its administration is facilitated by a latex-free device, prioritizing patient safety and convenience.

Tom Nusbickel, the Chief Commercial Officer at Celltrion USA, emphasized the company’s commitment to increasing access to innovative and high-quality biologics within the United States. With a successful track record globally, including the launch of the first monoclonal antibody biosimilar infliximab, Celltrion is confident in the successful introduction of Yuflyma to the U.S. market. Professor Jonathan Kay of UMass Chan Medical School acknowledged the significance of Yuflyma’s launch, highlighting the benefits it brings to patients with its high-concentration and citrate-free formulation.

To enhance the experience of patients and healthcare providers using Yuflyma, Celltrion USA has introduced two support programs: the Celltrion CONNECT Patient Support Program and the Celltrion CARES Co-pay Assistance Program, starting from July 10th. These programs aim to facilitate benefits verification, prior authorization assistance, and co-pay assistance, ensuring that eligible patients can access Yuflyma at an affordable cost. The Celltrion CONNECT Patient Assistance Program (PAP) provides support for uninsured or underinsured patients, while nurses will be available to address patient inquiries and provide training.

Looking ahead, Celltrion is actively seeking an interchangeability designation from the U.S. FDA for Yuflyma, which is tentatively expected to be granted in the fourth quarter of 2024. The company is also conducting Phase 3 clinical trials globally to establish Yuflyma’s interchangeability with the original treatments in the United States and Europe. Completion of these trials is scheduled for the end of the following year. Additionally, Celltrion Healthcare plans to expand the prescription of Yuflyma by enhancing its competitiveness in the market.

The launch of Yuflyma by Celltrion in the United States signifies a significant milestone for the company and offers patients and healthcare providers a valuable biosimilar option for the treatment of autoimmune diseases. Yuflyma’s high-concentration, citrate-free formulation, combined with the patient support programs, aims to improve patient experiences and contribute to better treatment outcomes.

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