Celltrion has launched an 80-mg dosage form of its biosimilar Yuflyma (adalimumab) for the treatment of autoimmune diseases in the United States.
Celltrion said on Jan. 17 that 80 mg is the same high-concentration (100 mg/ml) formulation as the 40 mg version that became available in the United States last year. It came in two products: an autoinjector and a prefilled syringe.
The price is the same as its 40 mg version to reflect the needs of patients, doctors, and other stakeholders. In the first quarter of this year, a 20 mg dose of Yuflyma for pediatric patients will also be introduced to the market.
The 80 mg dose will be focused on patients who are diagnosed with an autoimmune disease and are receiving their first prescription. The 80 mg version will provide first-time prescribers who need to take more than two 40-mg doses, patients who need to increase their dose due to a decrease in treatment effectiveness, and patients who suffer from injection phobia with greater convenience as it reduces the time needed to take the drug.
Like the 40-mg version, citrate, which can cause pain in patients, and substances that can cause allergies have been removed. Yuflyma has its own product competitiveness, such as maintaining safety for 31 days at room temperature (25℃).
Celltrion is also in the process of applying for an amendment to secure interchangeability with the original drug in the United States. Interchangeability status will allow pharmacies to prescribe Yuflyma with the same efficacy and safety as the original drug without a need for doctors’ intervention.
“This additional dose formulation will provide doctors and patients with more flexible options and convenient self-administration,” said Tom Nusbickel, chief commercial officer at Celltrion USA.