Celltrion, a Korean biopharmaceutical giant, said it has launched a 20-mg dosage formulation of its biosimilar Yuflyma (adalimumab) to treat autoimmune diseases in pediatric patients in the U.S.

Yuflyma 20mg is the same high-concentration (100mg/mL) formulation as the 40mg and 80 mg, which were launched in the U.S. last year and this past January. It is available in a prefilled syringe (PFS), Celltrion said Thursday. The price of 20mg is the same as the previous dose formulation, considering Yuflyma's competitiveness and its needs in medical fields, the company said. 

Expanding Yuflyma's lineup aims to cater to individual patient needs, including pediatric cases and those requiring higher doses. This move strengthens Celltrion's autoimmune disease treatment portfolio, alongside Inflectra and Zymfentra, the company said.

In addition to Inflectra (Remsima’s U.S. name), currently available in the U.S., the launch of Zymfentra (Remsima SC’s U.S. name), the world's only subcutaneous (SC) formulation of infliximab, brings the total number of Celltrion's autoimmune disease treatments to three.

“As a company that provides physicians with a wide range of prescribing options in the autoimmune disease space, we expect to accelerate prescribing expansion through portfolio synergies,” Celltrion said.

In addition, the company said the ongoing approval of changes to secure interchangeability with the original product is expected to strengthen Yuflyma's competitiveness. Securing interchangeability status will allow pharmacies to prescribe Yuflyma with the same efficacy and safety as the original product without physician intervention, enabling more aggressive marketing strategies.

Yuflyma's original drug, Humira, is a global blockbuster with sales of about $21.23 billion (27.6 trillion won) in 2022. Of this, the U.S., the world's largest pharmaceutical market, accounted for about $18.69 billion, more than 87 percent of the total sales.

"The launch of Yuflyma 20mg will provide pediatric patients with autoimmune diseases in the U.S. with more flexible options and convenient self-administration," a Celltrion official said. "The availability of three dosage forms allows for customized prescribing based on the patient's case, which is expected to increase physician prescribing preference for Yuflyma. We will continue to leverage these product strengths in our marketing efforts to expand U.S. sales of Yuflyma."