Importance: Biosimilar drugs provide cost-effective yet clinically indistinguishable replications of target drugs. During initial development, this class of biologic medicines was expected to revolutionize pharmaceutical markets; however, following US Food and Drug Administration approval of the first biosimilar drug in 2015, the commercialization of biosimilars has been limited. The lack of biosimilar use may be especially salient in oncology, given that biosimilar distribution in this particularly high-cost area of medicine would bring savings on the order of many billions of dollars.
Observations: While researchers have focused on salient economic barriers to biosimilar uptake in the US, the present review provides insight regarding noneconomic barriers. This review discusses psychological, attitudinal, and educational factors among both health care professionals and payers in the US that may play a role in slowing biosimilar uptake. More specifically, these factors include a lack of health care professional education, concerns of safety and efficacy, and overly complex product naming systems.
Conclusions And Relevance: The pathway to biosimilar use has been obstructed by economic elements as well as attitudinal and psychological factors. For biosimilar drugs to achieve their potential in decreasing treatment costs and thus increasing patient access, it will be essential for both economic and noneconomic factors to be identified and systematically addressed.
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http://dx.doi.org/10.1001/jamaoncol.2024.1447 | DOI Listing |
Zhonghua Nei Ke Za Zhi
February 2025
Department of Interventional Radiology, the First Affiliated Hospital of Soochow University, Suzhou215000, China.
To investigate the efficacy and safety of transarterial chemoembolization (TACE) combined with sintilimab and bevacizumab biosimilar in the treatment of unresectable hepatocellular careinoma (uHCC). The clinical data of 64 patients with unresectable HCC, who were admitted to the First Affiliated Hospital of Soochow University between January 2021 and December 2023, were retrospectively analyzed. The patients were divided into a combination group (=43, receiving TACE combined with sintilimab and bevacizumab biosimilar) and control group (=21, receiving only sintilimab and bevacizumab biosimilar).
View Article and Find Full Text PDFBiomedicines
January 2025
College of Pharmacy, University of Illinois, Chicago, IL 60612, USA.
mRNA technology can replace the expensive recombinant technology for every type of protein, making biological drugs more affordable. It can also expedite the entry of new biological drugs, and copies of approved mRNA products can be treated as generic or biosimilar products due to their chemical nature. The introduction of hundreds of new protein drugs have been blocked due to the high cost of recombinant development.
View Article and Find Full Text PDFBiomedicines
December 2024
National Institute of Biologicals, Ministry of Health & Family Welfare, Govt. of India, A-32, Sector-62, Noida 201309, UP, India.
Trastuzumab is an effective therapeutic intervention for treating HER2-positive breast cancers. The cost-effectiveness, global demand, and patent expiration of trastuzumab have led to the inflow of its biosimilars in the global market. With the rise of biosimilars in the biopharmaceutical market, it has become crucial to ensure that the biosimilar is at par with the original monoclonal antibody (mAb)in terms of efficacy, safety, and quality.
View Article and Find Full Text PDFBMC Ophthalmol
January 2025
Department of Vitreoretina, Akhand Jyoti Eye Hospital, Mastichak, Saran, Bihar, India.
Purpose: To compare the anatomical and visual outcomes in eyes with submacular hemorrhage (SMH) treated with a combination of ranibizumab (RBZ) either innovator or biosimilar (Razumab) and intravitreal perfluoropropane gas (CF).
Methods: Treatment naïve neovascular age related macular degeneration (n-AMD) patients with SMH were retrospectively analyzed. Patients received either innovator or biosimilar RBZ (3 loading doses followed by pro re nata regimen) and single injection of intravitreal CF.
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.
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