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Samsung Bioepis Releases First Quarter 2024 US Biosimilar Market Report
January 17, 2024 02:00 ET | 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...
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Samsung Bioepis Secures US License Date for SB17, a Proposed Biosimilar to Stelara®
November 30, 2023 01:00 ET | 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...
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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 | 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...
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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 | 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...
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Samsung Bioepis Presents Two Abstracts at EADV 2023 Congress, Highlighting Continuous Dedication in Dermatology
October 11, 2023 03:00 ET | 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...
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Samsung Bioepis Releases Fourth Quarter 2023 US Biosimilar Market Report to Provide the Latest US Market Biosimilar Trends
October 10, 2023 02:00 ET | 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 ...
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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 | 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...
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Samsung Bioepis Partners with Sandoz to Commercialize Ustekinumab Biosimilar Candidate
September 11, 2023 01:15 ET | 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...
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Samsung Bioepis & Organon Announce Topline Results from Interchangeability Study of SB5 Humira Biosimilar
August 01, 2023 07:00 ET | 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...
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Samsung Bioepis Releases its Second US Biosimilar Market Report
July 11, 2023 07:00 ET | Samsung Bioepis
Details updated average sales price (ASP) trends and market share across all molecules for which biosimilars are availableIncludes Wholesale Acquisition Cost (WAC) trends of recently launched...