Samsung Bioepis Begins Phase 3 Clinical Trial For Stellara Biosimilar (SB17)

• Comparative study with original drugs for 464 plaque psoriasis patients in 8 countries
• Four biosimilar pipelines under development (SB12, SB15, SB16, SB17) All entered phase 3 clinical trials
• Samsung Bioepis (CEO Hanseung Koh) has started phase 3 clinical trials for its 10th biosimilar pipeline, SB17 (Stellara biosimilar, ingredient name: Ustekinumab).

According to the information published on the global clinical trial information website 'clinicaltrials.gov' on the 19th, Samsung Bioepis has been offering 464 patients with moderate and high severity levels in 8 countries, including Poland, the Czech Republic, and Korea, since July this year.  Initiated a phase 3 clinical trial of SB17 to conduct comparative studies on efficacy, safety, and immunogenicity compared to the original drug for patients with moderate to severe plaque psoriasis ^1) .
* Note (Web Link): https: // www.clinicaltrials.gov/ct2/show/NCT04967508

Stella d (Stelara) is a self-developed by Janssen, such as psoriasis (Janssen), psoriatic arthritis, Crohn's disease, ulcerative colitis As an immune disease treatment, the annual global sales amounted to about KRW 8.4 trillion ($7.77B)²⁾ last year.

Samsung Bioepis has been conducting phase 1 clinical trials of SB17 in France on 201 healthy adults since February this year, and phase 3 clinical trials on actual patients from July, enabling accelerated development.

An official from Samsung Bioepis said, “We will do our best to further expand the access to treatment for many patients around the world by developing SB17 in addition to the autoimmune disease treatment that is actively sold in Europe.

Meanwhile, Samsung Bioepis has a total of 10 biosimilar products and pipelines this year, celebrating its 10th anniversary, and has three autoimmune disease treatments (SB2: Remicade biosimilar, SB4: Enbrel biosimilar, SB5: Humira biosimilar) and two anticancer drugs (SB3: Herceptin biosimilar, SB8: Avastin biosimilar) are being sold in global markets including Europe.

In addition, SB11 (Lucentis biosimilar), an ophthalmic disease treatment, received a recommendation for approval from the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency in June.

In addition, we are expanding our pipeline to various areas such as blood disease and skeletal disease treatment. With the entry into phase 3 clinical trial of SB17, we expanded the development pipeline for autoimmune disease treatment and 4 follow-up biosimilars under development ( SB12: Soliris biosimilar, SB15: Eylea biosimilar, SB16: Prolia biosimilar, SB17: Stellara biosimilar) have all entered phase 3 clinical trials.

¹⁾ Plaque Psoriasis: The most common type of psoriasis classified into five categories, accounting for 8-90% of all psoriasis, a disease in which silvery-white scales cover the skin in the form of red plaques with clear boundaries (source: The Korean Society for Psoriasis  https://kspder.or.kr/type )

²⁾ Revenue Source: Johnson & Johnson 2020 annual report ( https://www.investor.jnj.com/annual-meeting-materials/2020-annual-report ) 
Exchange rate: Apply the trading standard rate (1,087 won) as of the end of 2020