Adalimumab-adbm (Cyltezo) has been approved as an interchangeable biosimilar product to adalimumab (Humira). This means it can be substituted at the pharmacy for Humira without being specified in the prescription.Nurses should inform patients who have been receiving Humira that they may receive Cyltezo instead, and that this is not a pharmacy error.
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http://dx.doi.org/10.1097/01.NAJ.0000820544.63258.6b | DOI Listing |
AAPS PharmSciTech
January 2025
School of Pharmaceutical Sciences, Delhi Pharmaceutical Sciences and Research University, New Delhi, India, 110017.
The biopharmaceutical industry has witnessed significant growth in the development and approval of biosimilars. These biosimilars aim to provide cost-effective alternatives to expensive originator biosimilars, alleviating financial pressures within healthcare. The manufacturing of biosimilars is a highly complex process that involves several stages, each of which must meet strict regulatory standards to ensure that the final product is highly similar to the reference biologic.
View Article and Find Full Text PDFInt J Pharm
January 2025
Department of Pharmaceutics, College of Pharmacy, University of Minnesota, Minneapolis, MN 55455, United States. Electronic address:
For monoclonal antibody drug products as for other biologics, while the innovator drug products first becomes commercially available, they are often followed by one or more biosimilar products. These biosimilars often differ from the innovator product, as well as from each other, in their formulation composition. However, the impact of the formulation composition on the stability of the active pharmaceutical ingredient subjected to different 'stresses' is still not understood.
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 PDFWorld 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.
J Chromatogr A
January 2025
Center of Molecular Immunology, 216 Street and 15th Avenue Atabey-Siboney Playa P.O. Box 16040, Havana, 11600, Cuba. Electronic address:
Protein A chromatography represents the most prevalent methodology for the capture of monoclonal antibodies. The use of a low pH elution buffer from Protein A has been observed to contribute to product aggregation, particularly in the case of IgG4 antibodies, such as nivolumab. This paper presents a well-defined strategy for addressing this issue.
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