Samsung Bioepis Reveals Humira and Stelara Biosimilar Research Results at US Dermatology Conference

Samsung Bioepis announced on the 10th that it presented the clinical trial results of SB5 and SB17, biosimilars developed respectively for Humira and Stelara, autoimmune disease treatments, at the American Academy of Dermatology (AAD) Annual Meeting held from the 8th to the 12th (local time) in San Diego, California, USA.

Exterior view of Samsung Bioepis building in Songdo, Incheon [Photo by Samsung Bioepis]

SB5 is currently marketed in the United States under the product name Hadlima. A Phase 4 clinical trial to confirm interchangeability with the original drug was conducted, and the results were disclosed at this conference. The Phase 4 interchangeability clinical trial targeted patients with moderate to severe plaque psoriasis and evaluated pharmacokinetics, efficacy, safety, and immunogenicity between the original drug administration group and the switch administration group that switched from the original drug to SB5. Through this, biological equivalence between the administration groups was confirmed, fulfilling interchangeability requirements.

Hadlima received approval from the U.S. Food and Drug Administration (FDA) for low concentration (50 mg/mL) and high concentration (100 mg/mL) formulations in 2019 and 2022, respectively, and was launched in the U.S. in July last year. Sales are handled by partner Organon.

At this conference, the final 52-week results of the Phase 3 clinical trial for SB17 were also presented. The clinical trial compared long-term efficacy, safety, and immunogenicity among the SB17 administration group, the original drug administration group, and the switch administration group that switched from the original drug to SB17. All three groups showed similar results, confirming equivalence with the original drug.

Last month, SB17 received a positive opinion for marketing authorization under the product name Fiztiva from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). The FDA’s marketing authorization review is also underway in the United States. After approval, partner Sandoz plans to handle sales in Europe and the U.S.

Hong Ilseon, Head of the Product Evaluation (PE) Team at Samsung Bioepis, who presented the research results, said, "We will continue to research and provide scientific evidence on the clinical equivalence in terms of efficacy and safety of biosimilar products in the field of immunology compared to the original drugs."

This content was produced with the assistance of AI translation services.