Samsung Bioepis announced on Wednesday that it has received approval from the Food and Drug Administration for the pre-filled pen formulation (PFP) of its autoimmune disease treatment, Epyztek (a biosimilar to Stelara, with the active ingredient ustekinumab).

This marks a significant milestone as the first pen formulation to receive regulatory approval in the country, distinguishing it from the existing pre-filled syringe formulation (PFS) of ustekinumab-based medications, including the original drug. The development is noteworthy for its improved ease of administration for patients.

The pen formulation is engineered to allow patients to administer the drug more easily and precisely, offering particular benefits for those who self-administer.

Epyztek is a biosimilar of Stelara, a drug developed by Janssen for the treatment of autoimmune conditions such as plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. Stelara's global annual sales reach approximately 15 trillion KRW (about 11.25 billion USD).

The drug works by inhibiting the activity of interleukin (IL)-12 and IL-23, inflammatory cytokines involved in immune responses.

Jeong Byeong In, head of Samsung Bioepis' Regulatory Affairs team, stated that this FDA approval represents a significant step toward enhancing patient convenience by granting the first pen formulation approval for this medication in the U.S. The company remains committed to expanding access to treatment through patient-centered innovations.

Samsung Bioepis launched EpisTec in the U.S. market in 2024, pricing it about 40% lower than the original drug. The newly approved pen formulation is scheduled for release in the first half of this year.

The company markets the Stelara biosimilar under the name Pyzchiva (Epyztek's international brand) through its partner Sandoz in Europe and the United States. In Europe, it currently holds a leading 35% market share among Stelara biosimilar products.

Samsung Bioepis announced on Wednesday that it has received approval from the Food and Dru …

Samsung Bioepis Secures U.S. Approval for Pen-Style Stelara Biosimilar, Setting a Market First