·          Total expected savings from ustekinumab biosimilars estimated to be €526 million in Germany, the United Kingdom and Sweden over three years; annual saving per patient estimated to be €5,167, €709, and €3,388 in the respective countries
·          The Samsung Bioepis and Sandoz* biosimilar Pyzchiva^® (ustekinumab) has been commercially available in Europe since July 2024
·          Real-world safety and effectiveness of adalimumab biosimilar in Korea based on post-marketing surveillance was also presented at the meeting; Samsung Bioepis’s biosimilar Adalloce has been available in Korea since March 2021
 
[Press Release] INCHEON, Korea – Apr 10, 2025 – Samsung Bioepis Co., Ltd. today presented two sets of data, including the budget impact analysis on ustekinumab biosimilars’ cost savings in Germany, the United Kingdom (UK) and Sweden and the real-world safety and effectiveness of adalimumab biosimilar in South Korea at the 8th International Meeting on Intestinal Diseases in conjunction with the Annual Congress of the Korean Association for the Study of Intestinal Diseases (IMKASID 2025) held in Seoul, Korea.
 
“The two analyses presented at IMKASID 2025 are pivotal for those considering biosimilars. Not only do they support the proven safety and efficacy of biosimilars but also highlight significant economic benefits for payers and patients,” said Jeehoon Ghil, Vice President and Team Leader of Medical & Lifecycle Safety Team at Samsung Bioepis. “We are committed to generating more relevant and meaningful data to continually build confidence in biosimilars and contribute to a sustainable healthcare ecosystem worldwide.”
 
About the Budget lmpact Analysis to Assess Potential Cost Savings from the lntroduction of Ustekinumab Biosimilars in Germany, the UK, and Sweden:

The study, funded by Sandoz, aimed to assess the cost-saving potential from the introduction of ustekinumab biosimilars from a payer perspective in Germany, the UK, and Sweden for adult patients currently treated with reference ustekinumab having Crohn’s disease (CD), psoriasis (PsO), and psoriatic arthritis (PsA).
 
Budget impact model was developed to compare the healthcare costs between the “world without ustekinumab biosimilars” and “world with ustekinumab biosimilars” over a three-year time horizon. The annual share uptake was based on the case history of adalimumab biosimilars. Patient-level annual treatment dose was calculated for the new and maintenance pools using the EMA-approved label for each indication. Treatment costs of reference ustekinumab and biosimilars were based on June 2024 list price and analogue-based discounted prices, respectively.
 
This analysis estimated total savings of €440.0 million in Germany, €49.5 million (approximately £41.7 million) in the UK, and €36.8 million in Sweden over three years. Further, analysis estimated €5,167, €709 (approx. £597), and €3,388 patient-level annual savings in the respective countries.
 
About the Real-world Safety and effectiveness of SB5 (adalimumab biosimilar) in South Korea: A real-world post-marketing surveillance interim analysis data:

The study aimed to assess the safety and effectiveness of adalimumab biosimilar (SB5) in clinical practice for the approved indications of axial spondyloarthritis (axSpA), rheumatoid arthritis (RA), PsA, PsO, Ulcerative colitis (UC), CD, etc. in Korea.
 
238 patients (99 with axSpA, 129 with RA, 7 with CD, 2 with UC and 1 PsA) were enrolled and were monitored from September 2017 to June 2024. Safety was assessed by the incidence of adverse events (AEs), adverse drug reactions (ADRs) and serious adverse events (SAE). Effectiveness was assessed by the change from baseline of investigator-rated Korean Bath Ankylosing Spondylitis Disease Activity Index (KBASDAI) in axSpA patients, disease activity score-28 (DAS28) in patients with RA and Harvey-Bradshaw Index (HBI) in patients with CD.
 
It was concluded that SB5 was effective in Korean patients with axSpA, RA, CD, UC and PsA in real world setting without any new safety signal, which were consistent with those observed in the previous clinical studies.
 
Samsung Bioepis has a total of 11 biosimilars in its portfolio across immunology, oncology, ophthalmology, hematology, nephrology, and endocrinology. Currently, Samsung Bioepis has 11 biosimilars approved in Europe, 10 approved in the US and nine approved in Korea.