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Effectiveness and safety of biosimilars in pediatric inflammatory bowel diseases: an observational longitudinal study on the French National Health Data System.
World J Pediatr
January 2025
EPI-PHARE, French National Agency for Medicines and Health Products Safety (ANSM) and French National Health Insurance (CNAM), 143-147 Boulevard Anatole France, 93285, Saint-Denis, France.
Background: Data on biosimilar use in pediatric inflammatory bowel diseases (IBD) are scarce compared to the status of studies in adults, resulting in limitations in its treatment. We compared effectiveness and safety of biosimilars versus originators in this population.
Methods: We used data from the French National Health Data System to identify children (less than 18 years old at treatment initiation) initiating treatment with a biosimilar or the originator infliximab or adalimumab for Crohn's disease (CD) or ulcerative colitis (UC), from first biosimilar launch (January 2015 and October 2018, respectively) to 31 December 2022.
Global Harmonization of Biosimilar Development by Overcoming Existing Differences in Regional Regulatory Requirements - Outcomes of a Descriptive Review.
Ther Innov Regul Sci
January 2025
, Highland Park, NJ, USA.
Global harmonization of biosimilar developmental requirements will facilitate development leading to increased patient and societal benefits. However, there are several technical and regulatory hurdles that must be addressed to harmonize the regulatory requirements in different countries and regions. At times, there is a requirement for use of locally sourced reference product, forcing biosimilar developers to repeat analytical or clinical comparability studies against reference product batches sourced from within a given country.
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.
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.
Cross-sectional patient survey of biological medicine users in Finland to investigate the types of guidance needed by patients in order to carry out their treatment successfully.
BMJ Open
January 2025
Oriola Finland Oy, Espoo, Uusimaa, Finland
Background: The use of new biological medicines as standard treatment is expected to increase substantially and cover new therapeutic indications in the near future. Interchange of biological medicines in pharmacies increases the need for patient guidance.
Objectives: The study aims to gain a patient perspective on biological medicine users' needs and wishes regarding patient guidance by exploring what kind of information patients wish to receive and to further investigate the potential differences in needs between originator biological medicine users and biosimilar users.
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