Celltrion said it launched the 80mg/0.8mL dosage form of Yuflyma, a biosimilar referencing Abbvie's Humira (ingredient: adalimumab), in the U.S.

Humira, the original medicine, is prescribed primarily for autoimmune diseases such as rheumatoid arthritis, inflammatory bowel disease, and psoriasis. Yuflyma is FDA-approved to treat eight conditions, including Crohn's disease and ulcerative colitis.

Yuflyma 80mg is a high-concentration formulation identical to the 40mg version that started selling last year.

The company provides the formula in two product types -- an autoinjector (AI) and a prefilled syringe with a safety guard (PFS-S), and the company has set the price for the 80mg the same as the 40mg, reflecting the needs of various stakeholders, including patients and doctors.

Celltrion stressed that the newly launched Yuflyma 80mg is intended to be used primarily by patients who are diagnosed with autoimmune diseases and are receiving their first prescription.

The company expects that the increased dosage will significantly improve patient convenience in treatment and increase product preference as it reduces the number of doses for patients who would need more than two injections of 40mg, those who need to increase their dosage due to decreased treatment efficacy, and those suffering from fear of injection.

Yuflyma 80mg has also eliminated citrate, which can cause the patient pain, and substances that can trigger allergies, like the 40mg version. It maintains its safety at room temperature (25 Celcius) for up to 31 days, demonstrating Yuflyma's competitive product strength.

The company stressed that considering that over 80 percent of patients in the U.S. who are treated with Humira (the original product) use a high-concentration formulation without citrate, this launch of the 80mg dosage form is expected to increase the preference for Yuflyma significantly.

Notably, the ongoing application for a change permit to secure interchangeability with the original pharmaceutical in the U.S. is anticipated to strengthen Yuflyma's competitiveness further.

If interchangeability status is obtained, it will be possible to prescribe Yuflyma with the same efficacy and safety as the original medicine without a doctor's intervention, which the company expects will allow Celltrion USA to pursue more aggressive marketing strategies.

In addition to enhancing product competitiveness, the company is also conducting various marketing activities to expand the sales of Yuflyma, including the patient support program (Celltrion CONNECT), which provides support for prior authorization and co-pays for patients, and offers Yuflyma to insurance patients who meet certain conditions, uninsured patients, and patients whose insurance support is insufficient.

The company believes that these marketing activities will lead to increased awareness and preference for Yuflyma in the U.S., ultimately resulting in an actual expansion of prescriptions.

Celltrion is also seeking to introduce a 20mg dosage form of Yuflyma for pediatric patients in the first quarter of this year.

Yuflyma's original pharmaceutical, Humira, is a global blockbuster autoimmune disease treatment, recording sales of about $21.2 billion in 2022. The drug recorded sales of about $18.6 billion in the U.S. alone, accounting for more than 87 percent of its total sales.

"Yuflyma has demonstrated the same therapeutic efficacy, safety, pharmacokinetics and immunogenicity as the original, and the addition of the 80 mg dosage form provides physicians and patients with more flexible options and convenient self-administration," Celltrion USA CCO Thomas Nusbickel said. "We will actively continue our marketing activities based on product competitiveness through dosage diversification to deliver the treatment benefits of Yuflyma to more patients."