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Background: With increasing numbers of oncology biosimilars in the approval pipeline, it is important to investigate oncology clinicians' understanding of biosimilars and what information they need prior to adoption.
Methods: Between January and May 2018, 77 oncology clinicians (52 physicians, 16 pharmacists, and 9 advanced practice providers) completed a survey covering three domains: clinician understanding, prescription preferences, and patient involvement. An in-depth interview was designed based on themes identified in the first 50 surveys: cost, safety and efficacy, patient preference, and disease stage. Participants were chosen to participate in the interview based on outlying responses to survey questions.
Results: When asked to define a biosimilar, 74% (57/77) of respondents could not give a satisfactory definition, and 40.3% (31/77) considered a biosimilar the same as a generic drug. The most important factor in biosimilar prescription was safety and efficacy (4.51 out of 5) followed closely by cost differences (4.34 out of 5). A 40% increase (53.2-94.8%) in clinicians' prescribing likelihood was seen after a biosimilar is designated as interchangeable. Participants in this study were split regarding the importance of shared decision-making with patients [50.7% (39/77) important or extremely important, 39.0% (30/77) somewhat or not at all important]. Clinicians were also split concerning the role that pharmacists should play in the decision to prescribe or substitute biosimilars.
Conclusion: Understanding of biosimilars is low, and educational needs are high. The information that clinicians deem important to assess, such as safety, efficacy and cost, will need to be provided before they are comfortable prescribing biosimilars.
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http://dx.doi.org/10.1177/1758835918818335 | DOI Listing |
Dermatol Ther (Heidelb)
September 2025
Dermatology Clinic, University Hospital Company Polyclinic "G. Rodolico, San Marco", Catania, Italy.
Introduction: Psoriasis (PsO) is a common inflammatory dermatological condition with a substantial negative impact on patient quality of life. Several biological agents are available for the treatment of PsO, and clinicians and patients must consider various factors when deciding on the most appropriate biological agent.
Methods: Here, we report a set of consensus statements developed by an Italian PsO advisory board on use of the anti-interleukin-17A biological secukinumab in routine clinical practice.
J Oncol Pharm Pract
August 2025
College of Medicine & Health Sciences, Sultan Qaboos University, Al-Seeb, Oman.
IntroductionThe rising costs, complexity, and ethical challenges of anticancer therapies have created an urgent need for structured frameworks to ensure clinical efficacy, cost-effectiveness, and equitable access. Oncology stewardship (OS) has emerged as a promising model to optimize oncology pharmacotherapy and resource allocation. However, the lack of a unified model for OS implementation and evaluation represents a critical gap.
View Article and Find Full Text PDFJ Pharm Biomed Anal
December 2025
Pharmaceutical Sciences, Pfizer Inc, 375 N Field Drive, Lake Forest, IL, USA.
To evaluate the impact of glycosylation of Chinese Hamster Ovary (CHO) cell produced erythropoiesis-stimulating agents (ESAs) on in vivo efficacy, epoetin glycoforms were fractionated and characterized. A comprehensive series of biochemical, in vitro bio-functional analyses and in vivo potency assays were conducted to better understand the relationship of structure to function of epoetin glycoforms. The hyper-glycosylated ESA darbepoetin alfa was also assessed to understand the range of in vivo potency response.
View Article and Find Full Text PDFNaunyn Schmiedebergs Arch Pharmacol
August 2025
Office of Cellular and Tissue-Based Products, Pharmaceuticals and Medical Devices Agency, 3-3-2, Kasumigaseki, Chiyoda-ku, Tokyo, 100-0013, Japan.
The first biosimilar was approved in April 2006 in the EU, June 2009 in Japan, and March 2015 in the USA. However, a detailed comparison and trend analysis of the biosimilar approvals by the three agencies has not been reported. It is important to understand current biosimilar approval status, biosimilar drug lag, and drug loss (i.
View Article and Find Full Text PDFSaudi J Gastroenterol
July 2025
Department of Gastroenterology, King Fahad Specialist Hospital, Dammam, Saudi Arabia.
With a rising prevalence of inflammatory bowel disease (IBD) in Saudi Arabia, understanding national trends in biologic utilization is essential for optimizing clinical care and healthcare resource allocation. However, available data from the region remain very limited, and no prior comprehensive synthesis has been conducted to evaluate utilization patterns, outcomes, or cost implications. A comprehensive literature search was performed across PubMed, Cochrane Library, Google Scholar, and local Saudi medical journals up to April 2025.
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