Biological medicines have become indispensable in the treatment of patients with serious diseases such as cancer and inflammatory diseases. Biosimilars are medicines which are developed to be similar to existing biological medicines (the 'reference product'). For the European market, they are approved by the European Medicines Agency. Owing to the rising importance of biosimilar medicines, the European Association of Hospital Pharmacists (EAHP) decided to set out its position on key issues concerning biosimilar medicines in a position paper. The topics included the role of hospital pharmacists in the uptake of biosimilar medicines in healthcare with regard to selection, procurement, logistics, information, education and collecting real-life experience (eg, in monitoring and pharmacovigilance). In addition, the paper touches on the views of the association for the naming of biosimilar medicines, extrapolation of indications, interchangeability, switching and substitution of biosimilar medicines and the provision of information about biosimilar medicines.
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http://dx.doi.org/10.1136/ejhpharm-2018-001821 | DOI Listing |
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 PDFDrugs Real World Outcomes
January 2025
Biogen IDEC, Clinical Research, Biosimilars, Maidenhead, UK.
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.
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.
Expert Rev Clin Immunol
January 2025
Division of Rheumatology, Department of Medicine III, Medical University of Vienna, Vienna, Austria.
Background: CT-P47 is a candidate tocilizumab biosimilar that is currently in clinical development. We assessed the usability of CT-P47 self-administration via auto-injector (AI) in patients with rheumatoid arthritis (RA).
Research Design And Methods: This was a 12-week, single-arm, open-label, multiple-dose, Phase 3 study.
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