The Biosimilarity Concept: Toward an Integrated Framework for Evidence Assessment
Authors: Issam Zineh, Leah A. Christl
Journal: Annals of Internal Medicine (2016)

Editorials18 October 2016The Biosimilarity Concept: Toward an Integrated Framework for Evidence AssessmentIssam Zineh, PharmD, MPH and Leah A. Christl, PhDIssam Zineh, PharmD, MPHFrom U.S. Food and Drug Administration, Silver Spring, Maryland.Search for more papers by this author and Leah A. Christl, PhDFrom U.S. Food and Drug Administration, Silver Spring, Maryland.Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/M16-1559 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail Development of innovative biological products (or “biologics”) over the past several decades has had a profound effect on public health. Proliferation of biologics for the treatment of chronic, severe, or life-threatening diseases has improved patient quality of life, modified the course of several diseases, and led to reductions in disease-associated morbidity and mortality. Although biologics represent important therapies for many debilitating diseases, they also constitute a significant proportion of drug expenditures in health care systems. The U.S. Congress, recognizing the need for more affordable versions of biologics, passed the Biologics Price Competition and Innovation Act of 2009 (1). This act ...References1. Biologics Price Competition and Innovation Act in the Patient Protection and Affordable Care Act, PL 111-148 (2010). Google Scholar2. Chingcuanco F, Segal JB, Kim SC, Alexander GC. Bioequivalence of biosimilar tumor necrosis factor-α inhibitors compared with their reference biologics. A systematic review. Ann Intern Med. 2016;165:565-74. doi:10.7326/M16-1559 LinkGoogle Scholar3. AMCP Partnership Forum: biosimilars-ready, set, launch. J Manag Care Spec Pharm. 2016;22:434-40. [PMID: 27023697] doi:10.18553/jmcp.2016.22.4.434 CrossrefMedlineGoogle Scholar4. Khraishi M, Stead D, Lukas M, Scotte F, Schmid H. Biosimilars: a multidisciplinary perspective. Clin Ther. 2016;38:1238-49. [PMID: 26988243] doi:10.1016/j.clinthera.2016.02.023 CrossrefMedlineGoogle Scholar5. European Medicines Agency. Scientific guidelines: multidisciplinary: biosimilar. Accessed at www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000408.jsp on 10 July 2016. Google Scholar6. U.S. Food and Drug Administration. Biosimilars. Accessed at www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm290967.htm on 10 July 2016. Google Scholar Author, Article, and Disclosure InformationAffiliations: From U.S. Food and Drug Administration, Silver Spring, Maryland.Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M16-1559.Corresponding Author: Issam Zineh, PharmD, MPH, U.S. Food and Drug Administration, Office of Translational Sciences, Center for Drug Evaluation and Research, White Oak Building 51, Room 3177, 10903 New Hampshire Avenue, Silver Spring, MD 20993; e-mail, issam.[email protected]hhs.gov.Current Author Addresses: Dr. Zineh: U.S. Food and Drug Administration, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, White Oak Building 51, Room 3177, 10903 New Hampshire Avenue, Silver Spring, MD 20993.Dr. Christl: U.S. Food and Drug Administration, Office of New Drugs, Center for Drug Evaluation and Research, White Oak Building 22, Room 6426, New Hampshire Avenue, Silver Spring, MD 20993.This article was published at www.annals.org on 2 August 2016. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetailsSee AlsoBioequivalence of Biosimilar Tumor Necrosis Factor-α Inhibitors Compared With Their Reference Biologics Francine Chingcuanco , Jodi B. Segal , Seoyoung C. Kim , and G. Caleb Alexander Metrics Cited byBiosimilar medicines: Impact, opportunities and strategies. Twelve years of experience in EuropeMedicamentos biosimilares: impacto, oportunidades y estrategias. Doce años de experiencia en Europa 18 October 2016Volume 165, Issue 8Page: 595-596KeywordsBiologicsClinical pharmacologyDisclosureDrug administrationDrug research and developmentDrugsFood and Drug AdministrationPharmacokineticsSafetySystematic reviews ePublished: 2 August 2016 Issue Published: 18 October 2016 PDF downloadLoading ...