{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,20]],"date-time":"2026-09-20T11:03:13Z","timestamp":1789902193124,"version":"4.0.1"},"reference-count":19,"publisher":"SAGE Publications","issue":"5","license":[{"start":{"date-parts":[[2026,3,28]],"date-time":"2026-03-28T00:00:00Z","timestamp":1774656000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"funder":[{"DOI":"10.13039\/100002429","name":"Amgen","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100002429","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Hosp Pharm"],"published-print":{"date-parts":[[2026,10]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction:<\/jats:title>\n                    <jats:p>\n                      ABP 798 (rituximab-arrx, RIABNI\n                      <jats:sup>\u00ae<\/jats:sup>\n                      ) is a biosimilar to rituximab available as a sterile, preservative-free solution (10\u2009mg\/mL) in a single-use vial for intravenous (IV) infusion. The purpose of this study was to assess the physicochemical stability of ABP 798 after dilution with 0.9% (w\/v) saline or 5% (w\/v) dextrose.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>Two experimental arms designated \u201cpreliminary hold\u201d and \u201coptimized storage condition\u201d were assessed. For both arms, ABP 798 was diluted to 1 and 4\u2009mg\/mL with sterile 0.9% (w\/v) saline or 5% (w\/v) dextrose in IV bags. For the preliminary hold assessment, the IV bags were kept at 2\u00b0C to 8\u00b0C for up to 30\u2009days, followed by storage at 30\u00b0C for 24\u2009hours (h), and then infusion at ambient temperature. For the optimized storage condition assessment, the IV bags were kept at 2\u00b0C to 8\u00b0C for up to 30\u2009days (saline-diluted) or up to 24\u2009hours (dextrose-diluted), followed by storage at 30\u00b0C (saline-diluted) or 25\u00b0C (dextrose-diluted) for 24\u2009hours and infusion at two different infusion rates. Samples collected at different time points were evaluated for various product quality attributes.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>Saline-diluted ABP 798 was physicochemically stable after 30\u2009days of storage at 2\u00b0C to 8\u00b0C followed by storage at 30\u00b0C for 24\u2009hours, and then infusion, as determined by the absence of changes to quality attributes. Degradation was observed in dextrose-diluted ABP 798 after 30\u2009days of storage at 2\u00b0C to 8\u00b0C followed by 24\u2009hours storage at 30\u00b0C. Dextrose-diluted ABP 798 remained physicochemically stable after 24\u2009hours storage at 2\u00b0C to 8\u00b0C followed by 24\u2009hours at 25\u00b0C.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions:<\/jats:title>\n                    <jats:p>These results indicate that ABP 798 remains chemically and physically stable when diluted in IV bags with 0.9% (w\/v) saline stored at 2\u00b0C to 8\u00b0C for 30\u2009days or 5% (w\/v) dextrose stored at 2\u00b0C to 8\u00b0C for 1\u2009day. Overall, these findings provide strong evidence supporting the chemical and physical stability of ABP 798 under the tested conditions. It is essential for the end-user to ensure the overall quality of the prepared admixture by strictly adhering to the product\u2019s packaging insert instructions.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/00185787261424835","type":"journal-article","created":{"date-parts":[[2026,3,29]],"date-time":"2026-03-29T05:44:41Z","timestamp":1774763081000},"page":"493-503","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":0,"title":["Physicochemical Stability of the Rituximab Biosimilar ABP 798 in Intravenous Bags Following Preparation and Storage"],"prefix":"10.1177","volume":"61","author":[{"ORCID":"https:\/\/orcid.org\/0009-0007-7364-2601","authenticated-orcid":false,"given":"Jeremy","family":"Gastwirt","sequence":"first","affiliation":[{"name":"Amgen Inc., Thousand Oaks, CA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeff","family":"Brown","sequence":"additional","affiliation":[{"name":"Amgen Inc., Thousand Oaks, CA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Lai","sequence":"additional","affiliation":[{"name":"Amgen Inc., Thousand Oaks, CA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Golnaz","family":"Kamalinia","sequence":"additional","affiliation":[{"name":"Amgen Inc., Thousand Oaks, CA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Monica","family":"Goss","sequence":"additional","affiliation":[{"name":"Amgen Inc., Thousand Oaks, CA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2026,3,28]]},"reference":[{"key":"e_1_3_3_2_2","unstructured":"RIABNI\u2122 (Rituximab-Arrx) Prescribing Information. Amgen Inc.; February 2023."},{"key":"e_1_3_3_3_2","unstructured":"RITUXAN\u00ae (Rituximab) Injection Prescribing Information. Genentech Inc.; December 2021."},{"key":"e_1_3_3_4_2","doi-asserted-by":"publisher","DOI":"10.1007\/s12325-017-0612-x"},{"key":"e_1_3_3_5_2","unstructured":"European Medicines Agency. Committee for Medicinal Products for Human Use. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues. 2014. Accessed June 25 2024. https:\/\/www.ema.europa.eu\/en\/documents\/scientific-guideline\/guideline-similar-biological-medicinal-products-containing-biotechnology-derived-proteins-active_en-2.pdf"},{"key":"e_1_3_3_6_2","unstructured":"US Food and Drug Administration. Guidance for Industry: Scientific Considerations in Demonstrating Biosimilarity to a Reference Product. Published April 2015. Accessed June 25 2024. https:\/\/www.fda.gov\/media\/82647\/download"},{"key":"e_1_3_3_7_2","doi-asserted-by":"publisher","DOI":"10.1007\/s40259-017-0218-5"},{"key":"e_1_3_3_8_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.biologicals.2020.08.002"},{"key":"e_1_3_3_9_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.biologicals.2021.05.002"},{"key":"e_1_3_3_10_2","doi-asserted-by":"publisher","DOI":"10.1002\/cpdd.845"},{"key":"e_1_3_3_11_2","doi-asserted-by":"publisher","DOI":"10.1007\/s11523-020-00748-4"},{"key":"e_1_3_3_12_2","doi-asserted-by":"publisher","DOI":"10.1007\/s10067-020-05305-y"},{"key":"e_1_3_3_13_2","unstructured":"United States Pharmacopeia. General Chapter \u3008787\u3009 Subvisible Particulate Matter in Therapeutic Protein Injections. USP-NF Online. United States Pharmacopeia; 2021. Accessed December 9 2025. https:\/\/doi.usp.org\/USPNF\/USPNF_M6497_02_01.html"},{"key":"e_1_3_3_14_2","unstructured":"European Medicines Agency. 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