SB5

Samsung Bioepis Presents Two Abstracts for Its Immunology Portfolio at the 2024 American Academy of Dermatology (AAD) Annual Meeting

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土曜日, 3月 9, 2024
EMA, Week, Psoriasis, Committee, SB5, Political moderate, Ustekinumab, Organon, FDA, Food, Samsung, BLA, Trial of the century, AAD, Safety, CHMP, Pharmacokinetics, Abstract, Biologics license application, American Academy, Novartis, Interchangeability

“We are excited to present new clinical data for our immunology portfolio at AAD Annual Meeting.

Key Points: 
  • “We are excited to present new clinical data for our immunology portfolio at AAD Annual Meeting.
  • The high-concentration (40 mg/0.4 mL) formulation of prefilled syringe and prefilled autoinjector of HADLIMA was approved in August 2022.
  • The study showed that efficacy, safety, and immunogenicity between the three arms were comparable up to Week 52.
  • Details of the Samsung Bioepis’ abstracts are as follows:
    Clinical Similarity of SB17 (Proposed Ustekinumab Biosimilar) to Reference Ustekinumab in Patients with Moderate to Severe Plaque Psoriasis: Randomized, Double-blind, Phase III, 52-Week Results

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

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水曜日, 10月 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

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月曜日, 9月 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 & Organon Announce Topline Results from Interchangeability Study of SB5 Humira Biosimilar

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火曜日, 8月 1, 2023
SB5, Psoriasis Area and Severity Index, Week, OGN, ADL, Psoriasis, Patient, Organon, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Interval (mathematics), NYSE, Food, Pharmaceutical industry, Generic drug, Cmax, Adalimumab

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 study for SB5, a biosimilar to Humira® (adalimumab).

Key Points: 
  • 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 study for SB5, a biosimilar to Humira® (adalimumab).
  • The primary objective of the study was to assess the pharmacokinetic similarity between two treatment groups: patients with moderate to severe plaque psoriasis who switched multiple times between Humira (ADL) and high-concentration SB5 versus patients receiving ADL continuously.
  • All 371 patients who were enrolled in the study had no prior treatment with ADL and were treated in this study with ADL during a lead-in period of 13 weeks.
  • HADLIMA was introduced into the U.S. commercial market on July 1, 2023 and is marketed by Organon.

REPEAT/Organon & Samsung Bioepis Announce US Launch of HUMIRA Biosimilar HADLIMA™ (adalimumab-bwwd) in Multiple Presentations Consistent with Originator

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水曜日, 7月 5, 2023
Medical Supplies, Medical Devices, Health, Clinical Trials, Pharmaceutical, Biotechnology, SB5, Infection, TNF, Arthritis, Hospital, TB, Organon & Co., Lymphoma, Intuition, Ankylosing spondylitis, Multimedia, Medicine, HCP, Ulcerative colitis, Psoriasis, Sepsis, Malignancy, Juvenile idiopathic arthritis, End-use certificate, Acquisition, Patient, Tuberculosis, Risk, Adolescence, Certification, Death, NYSE, Rheumatoid arthritis, Syringe, Pharmaceutical industry, Generic drug, Adalimumab, Organon

Organon & Co. (NYSE: OGN) & Samsung Bioepis Co., Ltd. announced that HADLIMA™ (adalimumab-bwwd), a biosimilar referencing Humira (adalimumab), is now available to patients in the United States.

Key Points: 
  • Organon & Co. (NYSE: OGN) & Samsung Bioepis Co., Ltd. announced that HADLIMA™ (adalimumab-bwwd), a biosimilar referencing Humira (adalimumab), is now available to patients in the United States.
  • Consistent with Humira, HADLIMA is available in both citrate-free high concentration (100 mg/mL) and citrate-containing low concentration (50 mg/mL) to provide patients with seamless continuity of care.
  • “We are thrilled to now provide HADLIMA in the US at a more affordable cost and expand much-needed access to adalimumab.
  • Each registered nurse will also be certified as a health coach to provide an experience tailored to fit the unique needs of each patient.

Organon & Samsung Bioepis Announce US Launch of HUMIRA Biosimilar HADLIMA™ (adalimumab-bwwd) in Multiple Presentations Consistent with Originator

Retrieved on: 
土曜日, 7月 1, 2023
Medical Supplies, Medical Devices, Health, Clinical Trials, Pharmaceutical, Biotechnology, SB5, Infection, TNF, Arthritis, Hospital, TB, Organon & Co., Lymphoma, Intuition, Ankylosing spondylitis, Multimedia, Medicine, HCP, Ulcerative colitis, Psoriasis, Sepsis, Malignancy, Juvenile idiopathic arthritis, End-use certificate, Acquisition, Patient, Tuberculosis, Risk, Adolescence, Certification, Death, NYSE, Rheumatoid arthritis, Syringe, Pharmaceutical industry, Generic drug, Adalimumab, Organon

Organon & Co. (NYSE: OGN) & Samsung Bioepis Co., Ltd. today announced that HADLIMA™ (adalimumab-bwwd), a biosimilar referencing Humira (adalimumab), is now available to patients in the United States.

Key Points: 
  • Organon & Co. (NYSE: OGN) & Samsung Bioepis Co., Ltd. today announced that HADLIMA™ (adalimumab-bwwd), a biosimilar referencing Humira (adalimumab), is now available to patients in the United States.
  • Consistent with Humira, HADLIMA is available in both citrate-free high concentration (100 mg/mL) and citrate-containing low concentration (50 mg/mL) to provide patients with seamless continuity of care.
  • “We are thrilled to now provide HADLIMA in the US at a more affordable cost and expand much-needed access to adalimumab.
  • Each registered nurse will also be certified as a health coach to provide an experience tailored to fit the unique needs of each patient.

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

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金曜日, 3月 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 Announces Health Canada Approval of Citrate-Free High-Concentration of HUMIRA®¹ Biosimilar (adalimumab; SB5)

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火曜日, 1月 3, 2023
Partnership, Psoriatic arthritis, Hidradenitis suppurativa, Health Canada, Rheumatoid arthritis, Adalimumab, Organon, Adolescence, SB5, Male, Ankylosing spondylitis, Patient, Uveitis, RA, Safety, Regulatory affairs, Psoriasis, Ulcerative colitis, Generic drug

INCHEON, Korea, Jan. 03, 2023 (GLOBE NEWSWIRE) -- Samsung Bioepis Co., Ltd. today announced that Health Canada has approved HADLIMA™ (also known as SB5) - a citrate-free, high concentration (40 mg/0.4 ML) formulation of biosimilar referencing HUMIRA® (adalimumab).

Key Points: 
  • INCHEON, Korea, Jan. 03, 2023 (GLOBE NEWSWIRE) -- Samsung Bioepis Co., Ltd. today announced that Health Canada has approved HADLIMA™ (also known as SB5) - a citrate-free, high concentration (40 mg/0.4 ML) formulation of biosimilar referencing HUMIRA® (adalimumab).
  • “We are pleased to receive Health Canada approval of our high concentration adalimumab biosimilar, marking a key milestone for us now to have both a low and high concentration adalimumab biosimilar approved in Canada,” said Byoungin Jung, Vice President and Regulatory Affairs Team Leader at Samsung Bioepis.
  • The study demonstrated PK equivalence between new SB5 formulation and prior SB5 formulation in healthy subjects.
  • HADLIMA was previously approved by Health Canada as a low-concentration (40mg/0.8mL) formulation in May 2018.

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

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水曜日, 9月 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)

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火曜日, 5月 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.