{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,7]],"date-time":"2026-09-07T04:07:46Z","timestamp":1788754066098,"version":"build-2803163510"},"reference-count":27,"publisher":"Wiley","license":[{"start":{"date-parts":[[2026,9,6]],"date-time":"2026-09-06T00:00:00Z","timestamp":1788652800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2026,9,6]],"date-time":"2026-09-06T00:00:00Z","timestamp":1788652800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["ascpt.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clin Pharma and Therapeutics"],"abstract":"<jats:p>\n                    Accurate identification of medicines used in adverse event reports is crucial for effective postmarketing safety surveillance. The US Food and Drug Administration's (FDA) four\u2010letter suffix naming convention was designed to facilitate accurate biological product identification, but the extent to which these suffixes have been incorporated into biosimilar reporting remains unclear. We conducted a cross\u2010sectional analysis of US adverse event reports for all 72 FDA\u2010approved biosimilar products in the FDA Adverse Event Monitoring System (AEMS) received through August 31, 2025, evaluating the proportion of reports containing a four\u2010letter suffix, proprietary name, or other manufacturer identifiers. Of 24,711 reports analyzed, 12.7% (\n                    <jats:italic>n<\/jats:italic>\n                    \u2009=\u20093126) contained a biosimilar suffix, whereas 98.2% (\n                    <jats:italic>n<\/jats:italic>\n                    \u2009=\u200924,264) contained a proprietary name and 82% reported the manufacturer name. Suffixes served as the sole product identifier in only 1.7% (\n                    <jats:italic>n<\/jats:italic>\n                    \u2009=\u2009413). These suffix\u2010only reports were distinct: more frequently submitted directly to FDA (86.2% vs. 15.0%), by healthcare professionals (73.3% vs. 59.0%), commonly originated from Veterans Affairs Medical Centers and specialty pharmacies and involved more serious outcomes (47.7% vs. 27.9%), suggesting certain organizational preferences favoring nonproprietary name reporting. The product distribution also differed, with adalimumab\u2010aacf most common in suffix\u2010only reports (18.9%) vs. infliximab\u2010dyyb overall (21.1%). Manufacturer information was present in 42.6% of suffix\u2010only reports. These results suggest FDA's nonproprietary naming convention has achieved limited implementation for biosimilars in AEMS reporting practices, and other information present in AEMS reports may be sufficient for accurately identifying biosimilar products.\n                  <\/jats:p>","DOI":"10.1002\/cpt.70478","type":"journal-article","created":{"date-parts":[[2026,9,7]],"date-time":"2026-09-07T03:19:11Z","timestamp":1788751151000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Analysis of Suffix Use for Biosimilar Product Identification in Postmarketing Adverse Event Reporting"],"prefix":"10.1002","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7814-7625","authenticated-orcid":false,"given":"Danijela","family":"Stojanovic","sequence":"first","affiliation":[{"name":"Office of Therapeutic Biologics and Biosimilars, Office of New Drugs, Center for Drug Evaluation and Research U.S. Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7372-6051","authenticated-orcid":false,"given":"Lisa","family":"Wolf","sequence":"additional","affiliation":[{"name":"Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research US Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M. Stacey","family":"Ricci","sequence":"additional","affiliation":[{"name":"Office of Therapeutic Biologics and Biosimilars, Office of New Drugs, Center for Drug Evaluation and Research U.S. Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9754-1986","authenticated-orcid":false,"given":"Monica A.","family":"Mu\u00f1oz","sequence":"additional","affiliation":[{"name":"Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research US Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,9,6]]},"reference":[{"key":"e_1_2_11_1_1","unstructured":"Food and Drug Administration.Biosimilars Action Plan: Balancing Innovation and Competition<https:\/\/www.fda.gov\/media\/114574\/download> (2018). Accessed February 13 2026."},{"key":"e_1_2_11_2_1","first-page":"6437","article-title":"Lowering Drug Prices by Once Again Putting Americans First, Exec Order No 14190","volume":"90","author":"Executive Office of the President","year":"2025","journal-title":"Fed. Regist."},{"key":"e_1_2_11_3_1","first-page":"30448","article-title":"Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Program for Contract Year 2024\u2010Remaining Provisions and Contract Year 2025 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, and Programs of All\u2010Inclusive Care for the Elderly (PACE)","volume":"89","author":"Centers for Medicare & Medicaid Services","year":"2024","journal-title":"Fed. Regist."},{"key":"e_1_2_11_4_1","doi-asserted-by":"crossref","first-page":"1473","DOI":"10.1001\/jama.2026.3088","article-title":"FDA's regulatory reforms to unlock competition and lower drug costs: breaking the biosimilar bottleneck","volume":"335","author":"Makary M.A.","year":"2026","journal-title":"JAMA"},{"key":"e_1_2_11_5_1","unstructured":"US Food and Drug Administration.Nonproprietary naming of biological products: guidance for industry<https:\/\/www.fda.gov\/regulatory\u2010information\/search\u2010fda\u2010guidance\u2010documents\/nonproprietary\u2010naming\u2010biological\u2010products\u2010guidance\u2010industry>. (2017). Accessed February 13 2026."},{"key":"e_1_2_11_6_1","unstructured":"US Food and Drug Administration.FDA Adverse Event Monitoring System (AEMS). US Food and Drug Administration <https:\/\/www.fda.gov\/safety\/fda\u2010adverse\u2010event\u2010monitoring\u2010system\u2010aems>. Accessed March 11."},{"key":"e_1_2_11_7_1","first-page":"927","article-title":"Biologics, pharmacovigilance, and patient safety: it's all in the name","volume":"22","author":"Stevenson J.G.","year":"2016","journal-title":"J. Manag. Care Spec. Pharm."},{"key":"e_1_2_11_8_1","first-page":"919","article-title":"Biosimilar naming conventions: pharmacist perceptions and impact on confidence in dispensing biologics","volume":"22","author":"Tomaszewski D.","year":"2016","journal-title":"J. Manag. Care Spec. Pharm."},{"key":"e_1_2_11_9_1","doi-asserted-by":"crossref","first-page":"338","DOI":"10.1007\/s40267-021-00844-z","article-title":"Knowledge of biosimilars and perceptions of the naming conventions for biosimilar products in clinical practice in the United States","volume":"37","author":"Olave M.","year":"2021","journal-title":"Drugs Ther. Perspect."},{"key":"e_1_2_11_10_1","doi-asserted-by":"crossref","first-page":"687","DOI":"10.1007\/s40264-015-0310-z","article-title":"Evaluating AE reporting of two off\u2010patent biologics to inform future biosimilar naming and reporting practices","volume":"38","author":"Stergiopoulos S.","year":"2015","journal-title":"Drug Saf."},{"key":"e_1_2_11_11_1","doi-asserted-by":"crossref","first-page":"225","DOI":"10.1001\/jama.2015.6170","article-title":"Competition in the age of biosimilars","volume":"314","author":"Chandra A.","year":"2015","journal-title":"JAMA"},{"key":"e_1_2_11_12_1","first-page":"188","article-title":"Assessment of pharmacists' views on biosimilar naming conventions","volume":"21","author":"Fernandez\u2010Lopez S.","year":"2015","journal-title":"J. Manag. Care Spec. Pharm."},{"key":"e_1_2_11_13_1","first-page":"8748","article-title":"Nonproprietary naming of biological products: update; draft guidance for industry; availability","volume":"84","author":"US Food and Drug Administration","year":"2019","journal-title":"Fed. Regist."},{"key":"e_1_2_11_14_1","doi-asserted-by":"crossref","first-page":"567","DOI":"10.1002\/cpt.3701","article-title":"FDA adverse event reporting system (FAERS) essentials: a guide to understanding, applying, and interpreting adverse event data reported to FAERS","volume":"118","author":"Potter E.","year":"2025","journal-title":"Clin. Pharmacol. Ther."},{"key":"e_1_2_11_15_1","unstructured":"US Food and Drug Administration.Biosimilar product information<https:\/\/www.fda.gov\/drugs\/biosimilars\/biosimilar\u2010product\u2010information>. Accessed August 31."},{"key":"e_1_2_11_16_1","doi-asserted-by":"crossref","first-page":"508","DOI":"10.1002\/cpt.81","article-title":"Patterns in spontaneous adverse event reporting among branded and generic antiepileptic drugs","volume":"97","author":"Bohn J.","year":"2015","journal-title":"Clin. Pharmacol. Ther."},{"key":"e_1_2_11_17_1","doi-asserted-by":"crossref","first-page":"812","DOI":"10.1002\/jhm.13170","article-title":"Off\u2010brand: a 6\u2010year study of medication brand and generic name usage in a multifacility academic healthcare system","volume":"18","author":"Steinkamp J.","year":"2023","journal-title":"J. Hosp. Med."},{"key":"e_1_2_11_18_1","doi-asserted-by":"crossref","first-page":"645","DOI":"10.1007\/s11606-006-0074-3","article-title":"What's in a name? Use of brand versus generic drug names in United States outpatient practice","volume":"22","author":"Steinman M.A.","year":"2007","journal-title":"J. Gen. Intern. Med."},{"key":"e_1_2_11_19_1","unstructured":"US Food and Drug Administration.Purple Book: Database of Licensed Biological Products<https:\/\/purplebooksearch.fda.gov\/>. Accessed February 26."},{"key":"e_1_2_11_20_1","volume-title":"Biosimilars in the United States 2023\u20102027: Competition S, and Sustainability","author":"IQVIA Institute for Human Data Science"},{"key":"e_1_2_11_21_1","doi-asserted-by":"crossref","first-page":"713","DOI":"10.1002\/pds.3979","article-title":"Completeness of serious adverse drug event reports received by the US Food and Drug Administration in 2014","volume":"25","author":"Moore T.J.","year":"2016","journal-title":"Pharmacoepidemiol. Drug Saf."},{"key":"e_1_2_11_22_1","doi-asserted-by":"crossref","first-page":"1042","DOI":"10.1002\/phar.2325","article-title":"Impact of a new consumer form on the quantity and quality of adverse event reports submitted to the United States Food and Drug Administration","volume":"39","author":"Mu\u00f1oz M.A.","year":"2019","journal-title":"Pharmacotherapy"},{"key":"e_1_2_11_23_1","doi-asserted-by":"crossref","first-page":"799","DOI":"10.1007\/s40264-017-0550-1","article-title":"An algorithm to identify generic drugs in the FDA adverse event reporting system","volume":"40","author":"Iyer G.","year":"2017","journal-title":"Drug Saf."},{"key":"e_1_2_11_24_1","doi-asserted-by":"crossref","first-page":"565","DOI":"10.1002\/pds.3223","article-title":"Quality assessment of spontaneous triggered adverse event reports received by the Food and Drug Administration","volume":"21","author":"Brajovic S.","year":"2012","journal-title":"Pharmacoepidemiol. Drug Saf."},{"key":"e_1_2_11_25_1","doi-asserted-by":"crossref","DOI":"10.3389\/fpubh.2024.1379973","article-title":"Data quality and timeliness analysis for post\u2010vaccination adverse event cases reported through healthcare data exchange to FDA BEST pilot platform","volume":"12","author":"Deady M.","year":"2024","journal-title":"Front. 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Sci."}],"container-title":["Clinical Pharmacology &amp; Therapeutics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpt.70478","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/cpt.70478","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpt.70478","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,9,7]],"date-time":"2026-09-07T03:19:19Z","timestamp":1788751159000},"score":1,"resource":{"primary":{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/10.1002\/cpt.70478"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,9,6]]},"references-count":27,"alternative-id":["10.1002\/cpt.70478"],"URL":"https:\/\/doi.org\/10.1002\/cpt.70478","archive":["Portico"],"relation":{},"ISSN":["0009-9236","1532-6535"],"issn-type":[{"value":"0009-9236","type":"print"},{"value":"1532-6535","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,9,6]]},"assertion":[{"value":"2026-04-14","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-08-24","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-09-06","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"cpt.70478"}}