Samsung Bioepis Gains European Commission Approval For PYZCHIVA™, a Biosimilar to Stelara (Ustekinumab)
22 avr. 2024 01h00 HE
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Samsung Bioepis
PYZCHIVA becomes Samsung Bioepis’ fourth EC-approved immunology biosimilar Sandoz to commercialize PYZCHIVA in Europe INCHEON, Korea, April 22, 2024 (GLOBE NEWSWIRE) -- Samsung Bioepis Co., Ltd....
Samsung Bioepis Releases Second Quarter 2024 US Biosimilar Market Report
08 avr. 2024 07h00 HE
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Samsung Bioepis
The 5th edition explores some IRA implications on biosimilars along with latest price trends, biosimilars market share Marks one year of providing quarterly updates on US biosimilar market trends ...
Samsung Bioepis Initiates Phase 3 Clinical Trial for SB27, Proposed Biosimilar to Keytruda (Pembrolizumab)
05 avr. 2024 01h00 HE
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Samsung Bioepis
INCHEON, Korea, April 05, 2024 (GLOBE NEWSWIRE) -- Samsung Bioepis Co., Ltd. today announced the initiation of Phase 3 clinical trial for SB27, the company's proposed biosimilar referencing...
Samsung Bioepis Presents Two Abstracts for Its Immunology Portfolio at the 2024 American Academy of Dermatology (AAD) Annual Meeting
09 mars 2024 10h05 HE
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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
17 janv. 2024 02h00 HE
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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®
30 nov. 2023 01h00 HE
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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®
07 nov. 2023 16h15 HE
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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
15 oct. 2023 19h00 HE
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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
11 oct. 2023 03h00 HE
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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
10 oct. 2023 02h00 HE
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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 ...