SB2

Samsung Bioepis Presents Two Abstracts at EADV 2023 Congress, Highlighting Continuous Dedication in Dermatology

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Wednesday, October 11, 2023
Congress, Partnership, SB5, Physician, PASI, European Academies' Science Advisory Council, Pharmacokinetics, Ustekinumab, Abstract, Medicine, Novartis, PK, Week, European Commission, Safety, Psoriasis, Biosimilar, Adalimumab, Samsung, UST, EC, SB2, Journal of the European Academy of Dermatology and Venereology, Infliximab, United Kingdom membership of the European Economic Area, Biogen, Civil service commission, Etanercept, Patient, Generic drug, Medical device, Dermatology, Venereology, EEA

The study demonstrated biosimilarity of SB17 to UST through equivalent efficacy and comparable safety and PK up to Week 28.

Key Points: 
  • The study demonstrated biosimilarity of SB17 to UST through equivalent efficacy and comparable safety and PK up to Week 28.
  • SB17 is Samsung Bioepis’ fourth candidate in immunology pipeline, following SB4 (etanercept), SB2 (infliximab) and SB5 (adalimumab).
  • Samsung Bioepis’ and Biogen’s anti-TNF treatment products have helped nearly 256,0003 patients in Europe.
  • Details of the Samsung Bioepis’ abstracts are as follows:

Samsung Bioepis Partners with Sandoz to Commercialize Ustekinumab Biosimilar Candidate

Retrieved on: 
Monday, September 11, 2023
SB5, European Economic Area, Etanercept, SB2, Adalimumab, Pharmacokinetics, Samsung, American Academy, Novartis, Trial of the century, Infliximab, AAD, American Academy of Dermatology, Congress, Safety, Generic drug, Mobile phone, EEA, Ustekinumab

Enters into a commercialization agreement for SB17, ustekinumab biosimilar candidate, in Europe and North America

Key Points: 
  • Enters into a commercialization agreement for SB17, ustekinumab biosimilar candidate, in Europe and North America
    INCHEON, Korea, Sept. 11, 2023 (GLOBE NEWSWIRE) -- Samsung Bioepis Co., Ltd. today announced that it has entered into a commercialization agreement with Sandoz for SB17, a proposed biosimilar to Stelarai (ustekinumab), marking a step forward in strengthening access to Samsung Bioepis’ immunology portfolio in the United States (US), Canada, European Economic Area (EEA), Switzerland and United Kingdom (UK).
  • “This agreement is a testament to Samsung Bioepis’ strong track record in the field of immunology, demonstrating a potential value that our biosimilars could deliver for widening access to biologic medicines.” said Sang-Jin Pak, Executive Vice President and Head of Commercial Division, at Samsung Bioepis.
  • SB17, a proposed biosimilar to Stelara (ustekinumab), is Samsung Bioepis’ fourth candidate in its immunology pipeline, following SB4 (etanercept), SB2 (infliximab) and SB5 (adalimumab).
  • Samsung Bioepis has a more than 5-year track record of supplying over 48 million units of immunology biosimilars in nearly 40 markets across the world.

Samsung Bioepis Presents Phase 1 Study Results of SB17 (Ustekinumab), A Proposed Biosimilar to Stelara, at 2023 AAD Annual Meeting

Retrieved on: 
Friday, March 17, 2023
SB5, PK, EU, Etanercept, Cis, SB2, Adalimumab, Pharmacokinetics, American Academy, Trial of the century, Infliximab, AAD, American Academy of Dermatology, Biosimilar, Ustekinumab, Interval (mathematics), Safety, Generic drug, Cmax

These results will be presented at the 2023 American Academy of Dermatology (AAD) Annual Meeting held in New Orleans, Louisiana, from March 17 to 21, 2023.

Key Points: 
  • These results will be presented at the 2023 American Academy of Dermatology (AAD) Annual Meeting held in New Orleans, Louisiana, from March 17 to 21, 2023.
  • In this Phase 1, randomized, double-blind, single-dose comparative pharmacokinetic study, a total of 201 subjects were randomized 1:1:1 to receive a single dose 45 mg of either SB17, EU-sourced reference ustekinumab, or US-sourced reference ustekinumab via subcutaneous injection.
  • The primary objective of this study was to demonstrate PK similarity by assessing area under the concentration-time curve from time zero to infinity (AUCinf) and maximum serum concentration (Cmax).
  • The secondary objectives were to investigate and compare the safety, tolerability, and immunogenicity between three treatment groups.

Samsung Bioepis Presents Three-year Follow-up Data of Adalimumab Biosimilar SB5 in Patients with Psoriasis at European Academy of Dermatology and Venereology (EADV) Congress

Retrieved on: 
Wednesday, September 7, 2022
Safety, Ophthalmology, Biogen, Hematology, Samsung, Endocrinology, Physician, LinkedIn, Royal commission, SD, Infliximab, Psoriasis, GLOBE, European Academy of Management, SB2, Adalimumab, Social media, Twitter, EC, Congress, Gastroenterology, European Commission, SB5, Patient, Pharmaceutical industry, Venereology, Dermatology

We hope that our continued efforts in providing real-world data help physicians and patients gain confidence in biosimilars.

Key Points: 
  • We hope that our continued efforts in providing real-world data help physicians and patients gain confidence in biosimilars.
  • The study included 1,059 patients with psoriasis registered in BADBIR from June 01, 2019 to August 31, 2021 who were treated with SB5.
  • SB5 was approved by the European Commission (EC) in August 2017, under the brand name IMRALDI as a biosimilar to HUMIRA2.
  • Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company.

Samsung Bioepis Announces New Data on Adalimumab Biosimilar, SB5 at the Annual European Congress of Rheumatology (EULAR 2022)

Retrieved on: 
Tuesday, May 31, 2022
Royal commission, Psoriatic arthritis, Social media, Medicine, Global Medical Device Nomenclature, Ulcerative colitis, European Commission, News, Patient, Poster, Samsung, SB5, EULAR, Ankylosing spondylitis, European, EC, Gastroenterology, Infliximab, Biogen, Hematology, Axial spondyloarthritis, RA, Congress, Safety, Rheumatoid arthritis, Endocrinology, SB2, LinkedIn, Inflammation, Twitter, Ophthalmology, Biosimilar, Male, Diagnosis, Adalimumab, GLOBE, Generic drug, Pharmaceutical industry, Rheumatology

The addition of new data to our adalimumab biosimilar, SB5 is great news for patients with rheumatic and other inflammatory diseases, said Donghoon Shin, Vice President and Medical & Lifecycle Safety Team Leader at Samsung Bioepis.

Key Points: 
  • The addition of new data to our adalimumab biosimilar, SB5 is great news for patients with rheumatic and other inflammatory diseases, said Donghoon Shin, Vice President and Medical & Lifecycle Safety Team Leader at Samsung Bioepis.
  • This real-world study, sponsored by Biogen GmbH, is designed to provide insights into outcomes of the transition from reference adalimumab to adalimumab biosimilar (SB5).
  • SB5 was approved by the European Commission (EC) in August 2017, under the brand name IMRALDI as a biosimilar to HUMIRA3.
  • Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company.

The Institute for Criminal Justice Training Reform Available for Comment on California’s Historic Passage of Criminal Justice Legislation

Retrieved on: 
Friday, October 1, 2021
Courts, Law Enforcement, Emergency Services, State, Local, Public Policy, Government, Other Policy Issues, SB2, Arrest, Police, Chief justice, Institute, Comment, Decision-making, Legislation, Employment Act of 1946, California Community Colleges, Peace, Accident, State, Private investigator

Randy Shrewsberry, Executive Director for the ICJTR, www.trainingreform.org , is available to comment on the new pieces of legislation.

Key Points: 
  • Randy Shrewsberry, Executive Director for the ICJTR, www.trainingreform.org , is available to comment on the new pieces of legislation.
  • The first piece of legislation, the Peace Officers Education and Age Conditions for Employment Act (AB89), is designed to increase the training standards of California Police Officers.
  • For too long we have treated the profession of policing with the training of a vocation, said Randy Shrewsberry, Executive Director of the Institute.
  • The Institute for Criminal Justice Training Reform exists to save lives and reduce injury among the public and the police.