Samsung Bioepis Presents Two Abstracts for Its Immunology Portfolio at the 2024 American Academy of Dermatology (AAD) Annual Meeting
March 09, 2024 10:05 ET
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Samsung Bioepis
Interchangeability study for HADLIMA (adalimumab-bwwd) was conducted in accordance with the FDA’s Guidance for Industry; primary pharmacokinetics (PK) endpoints as well as efficacy, safety and...
Samsung Bioepis Releases First Quarter 2024 US Biosimilar Market Report
January 17, 2024 02:00 ET
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Samsung Bioepis
Report highlights latest biosimilar pricing and market share status, including state of the adalimumab marketBiosimilar Deep Dive section illustrates patient benefit from lower adalimumab cost options...
Samsung Bioepis Secures US License Date for SB17, a Proposed Biosimilar to Stelara®
November 30, 2023 01:00 ET
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Samsung Bioepis
INCHEON, Korea, Nov. 30, 2023 (GLOBE NEWSWIRE) -- Samsung Bioepis Co., Ltd. has signed a settlement and license agreement with Johnson & Johnson settling all pending US patent litigation between...
Samsung Bioepis & Organon Announce FDA Acceptance of Supplemental Biologics License Application (sBLA) for Interchangeability Designation for HADLIMA™ (adalimumab-bwwd), a Biosimilar to Humira®
November 07, 2023 16:15 ET
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Samsung Bioepis
sBLA based on Phase 4 study which assessed pharmacokinetic similarity between two treatment groups: multi-switching group alternating between Humira and high-concentration HADLIMA vs. Humira-continued...
Samsung Bioepis Presents Phase 1 and 3 Clinical Results for SB16, a Proposed Biosimilar to Proliaⁱ (denosumab), at ASBMR 2023
October 15, 2023 19:00 ET
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Samsung Bioepis
Phase 1 study for SB16, proposed biosimilar to Prolia, demonstrates pharmacokinetic (PK) bioequivalence between SB16, EU-sourced denosumab, and US-sourced denosumab in healthy male study...
Samsung Bioepis Presents Two Abstracts at EADV 2023 Congress, Highlighting Continuous Dedication in Dermatology
October 11, 2023 03:00 ET
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Samsung Bioepis
Phase 3 study for SB17, Samsung Bioepis’ ustekinumab biosimilar candidate, demonstrates biosimilarity with reference ustekinumab through equivalent efficacy and comparable safety and pharmacokinetics...
Samsung Bioepis Releases Fourth Quarter 2023 US Biosimilar Market Report to Provide the Latest US Market Biosimilar Trends
October 10, 2023 02:00 ET
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Samsung Bioepis
Details the latest quarterly information on biosimilar utilization and financial datapoints for the US biosimilar marketExplores key determinants influencing various degrees of biosimilar utilization ...
Samsung Bioepis Presents Post-hoc Analysis of Phase 3 Clinical Trial for SB15, a Proposed Biosimilar to Eyleaⁱ (Aflibercept), at EURETINA 2023
October 07, 2023 11:00 ET
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Samsung Bioepis
Switching study conducted to evaluate whether switching from reference aflibercept to SB15 maintains comparable clinical efficacy and safetyPost-hoc analysis demonstrates biosimilarity between SB15...
Samsung Bioepis Partners with Sandoz to Commercialize Ustekinumab Biosimilar Candidate
September 11, 2023 01:15 ET
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Samsung Bioepis
Enters into a commercialization agreement for SB17, ustekinumab biosimilar candidate, in Europe and North America Partnership to support Samsung Bioepis pipeline expansion and provide increased...
Samsung Bioepis & Organon Announce Topline Results from Interchangeability Study of SB5 Humira Biosimilar
August 01, 2023 07:00 ET
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Samsung Bioepis
INCHEON, South Korea and JERSEY CITY, N.J., Aug. 01, 2023 (GLOBE NEWSWIRE) -- Samsung Bioepis Co., Ltd. and Organon & Co. (NYSE: OGN) today announced topline results from the interchangeability...