Biosimilars Development Check-in: New Data for Celltrion, Samsung Bioepis Candidates

Celltrion Healthcare released positive data for an ustekinumab biosimilar referencing Stelara and Samsung Bioepis announced long-term safety and efficacy results for its biosimilar referencing Humira (adalimumab). Both sets of data will be presented at the European Academy of Dermatology and Venereology Congress 2022 in Milan, Italy.

Long-term Data for Adalimumab Biosimilar

Samsung Bioepis shared data from a 3-year follow-up analysis of its adalimumab biosmilar (SB5; Hadlima) in patients with moderate to severe psoriasis.

The data was compiled from the British Association of Dermatologists Biologics and Immunomodulators Register, which is a registry for the United Kingdom and Ireland that assesses the long-term safety of biologics used to treat psoriasis. Samsung Bioepis has been participating in the registry since May 2016.

The study featured 1059 patients with psoriasis who were treated with SB5 between June 1, 2019 and August 31, 2021. After 3 years of therapy, the persistence rate for the cohort was 72.1%.

Therapy was discontinued for 275 out of 1096 treatments (25.1%). The mean (SD) duration of time that patients were on therapy was 19.3 (9.1) months. The cumulative persistence rate of SB5 at 1-year was 79.7%. At year 2, it was 73.5% and at year 3, it was 72.1%.

Jin Ah Jung, director of Medical Affairs Group at Samsung Bioepis commented on the results in a statement, saying, “Long-term real-world data on the effectiveness and safety of adalimumab biosimilars in psoriasis is limited, and study results from BADBIR demonstrate that SB5 is just as safe and effective as its reference adalimumab…. We hope that our continued efforts in providing real-world data help physicians and patients gain confidence in biosimilars.”

SB5 was granted marketing authorization in the European Union in August 2017, where it is marketed as Imraldi. Samsung Bioepis has a commercialization agreement with Biogen for the biosimilar, which gives Biogen the exclusive marketing rights to Imraldi along with Benepali (etanercept biosimilar; SB4) and Flixabi (infliximab biosimilar; SB2) throughout the European Union.

The low-concentration formulation of Hadlima was approved by the FDA in July 2019 and the high-concentration version (Hadlima HCF) was approved in August 2022. Both formulations of the biosimilar will launch in July 2023 along with 5 or 6 others, depending on if the FDA also approves Alvotech’s candidate (AVT02) and Celltrion’s biosimilar (Yuflyma). Although the low-concentration Hadlima will have citrate, Hadlima HCF will be citrate-free.

Samsung Bioepis is currently testing Hadlima in switching studies so that it can apply for an interchangeability designation in the United States. However, the approval for interchangeability is expected after the products launches on the market.

Celltrion Results for Ustekinumab Biosimilar

According to a report from Yonhap News Agency, Celltrion verified the safety and efficacy of its ustekinumab candidate (CT-P43) compared to the reference product in a global phase 3 trial. The trial took place over 28 weeks and included 509 patients with plaque psoriasis.

The results come after Formycon announced comparable safety and efficacy findings between its ustekinumab candidate (FYB202) and Stelara. Alvotech, Amgen, and BioFactura are also in the process of developing and testing their respective ustekinumab biosimilars (AVT04, ABP 654, and BFI-751, respectively).

Additionally, Bio-Thera Solutions and Hikma Pharmaceuticals have entered a partnership to develop and commercialize an ustekinumab biosimilar, and Samsung Bioepis is conducting a phase 3 trial for its candidate (SB17). Other candidates in development include NeuClone’s Neulara and Meiji Seika Pharma and Dong-A Socio Holdings’ DMB-3115.

Ustekinumab is used to treat several autoimmune conditions, including psoriasis, Crohn disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis.