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Evaluation of the Safety and Efficacy of Trastuzumab Emtansine (T-DM1) Biosimilar in Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer: Findings From a Single-Center Retrospective Analysis in India.
Cureus
December 2024
Medical Affairs, Zydus Lifesciences, Ahmedabad, IND.
Background Human epidermal growth factor receptor 2 (HER2)-positive breast cancer is a highly aggressive subtype characterized by a high recurrence rate. Trastuzumab emtansine (T-DM1), an antibody-drug conjugate targeting HER2, has shown improved outcomes; however, its effectiveness in cases with brain metastases remains unclear. The T-DM1 biosimilar has emerged as a cost-effective treatment option.
View Article and Find Full Text PDFCorrection: Real-World Evidence of Clinical Outcomes of the Use of the Adalimumab Biosimilar SB5 in Rheumatic and Gastrointestinal Immune-Mediated Inflammatory Diseases: 12-Month Data from the PERFUSE Study.
Drugs Real World Outcomes
January 2025
Biogen IDEC, Clinical Research, Biosimilars, Maidenhead, UK.
Characterization for the Similarity Assessment Between the Proposed Biosimilar SB17 and Ustekinumab Reference Product Using State-of-the-Art Analytical Methods.
Drugs R D
January 2025
Quality Evaluation Team, Samsung Bioepis Co., Ltd, Incheon, South Korea.
Background: SB17 is being developed as a biosimilar to ustekinumab reference product (RP), a human monoclonal antibody (IgG1 kappa immunoglobulin) that binds to the common p40 subunit of cytokines interleukin (IL)-23 and IL-12. Binding to this subunit prevents interaction with their receptor, resulting in modulation in the immune system responses that play a key role in inflammatory disease.
Objective: The objective of this study was to demonstrate structural, physicochemical, and biological similarity between ustekinumab RP and SB17 using various state-of-the-art analytical methods.
2024 Update of the Japan College of Rheumatology Clinical Practice Guidelines for the Management of Rheumatoid Arthritis - secondary publication.
Mod Rheumatol
January 2025
Inflammation and Immunology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan. 465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto-shi, Kyoto, 602-8566, Japan.
Objectives: To update the Japan College of Rheumatology Clinical Practice Guidelines for the Management of Rheumatoid Arthritis (CPG for RA).
Methods: The recommendations were developed based on the evidence published until the end of June 2022 using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE). The steering committee, CPG panel, systematic review (SR) group, and SR support team were organised.
Biosimilars in pediatric rheumatology: innovations, challenges, and opportunities.
Expert Opin Biol Ther
January 2025
Department of Pediatric Rheumatology, Kocaeli University, Kocaeli, Turkey.
Article Synopsis
- Biosimilars are biologic drugs that mimic established medications for treating rheumatic diseases and become available as cost-effective alternatives once original patents expire.
- Since their introduction in pediatric rheumatology in 2013, several biosimilars have been launched, offering more treatment options for children with conditions like juvenile idiopathic arthritis.
- The article emphasizes the need for education and effective communication among healthcare providers and patients to enhance understanding and ensure proper use of biosimilars.
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