Samsung Bioepis Initiates Phase 1 Clinical Trial for SB27, Proposed Biosimilar to Keytruda (Pembrolizumab)
22 Feb 2024
Phase 1Phase 3Drug Approval
INCHEON, Korea I February 21, 2024 I Samsung Bioepis Co., Ltd. today announced the initiation of Phase 1 clinical trial for SB27, the company's proposed biosimilar referencing Keytruda (pembrolizumab). The Phase 1 clinical trial for SB27 is a randomized, double-blind, three-arm, parallel group, multicenter study to compare the pharmacokinetics, efficacy, safety, and immunogenicity of pembrolizumab (SB27, EU-sourced Keytruda, and US-sourced Keytruda) in patients with stage II-IIIA non-small cell lung cancer following complete resection and adjuvant platinum-based chemotherapy. More information on this study is available at clinicaltrials.gov (NCT06268613).
As of February 2024, Samsung Bioepis has seven biosimilars approved and available around the worldi –SB4 (etanercept), SB2 (infliximab), SB5 (adalimumab), SB3 (trastuzumab), SB8 (bevacizumab), SB11 (ranibizumab), and SB12 (eculizumab) – along with four other biosimilar candidates in pipeline – SB15 (aflibercept), SB16 (denosumab), and SB17 (ustekinumab) all of which have completed Phase 3 clinical trial and SB27 (pembrolizumab) in Phase 1 clinical trial.
Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biosimilar candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, and endocrinology. For more information, please visit: www.samsungbioepis.com and follow us on social media – X (Twitter), LinkedIn.
SOURCE: Samsung Bioepis
For more details,please visit the original website
The content of the article does not represent any opinions of Synapse and its affiliated companies. If there is any copyright infringement or error, please contact us, and we will deal with it within 24 hours.
Organizations
Indications
Targets
-Drugs
Hot reports
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Leverages most recent intelligence information, enabling fullest potential.