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Assessing the safety and comparative effectiveness of follow-on biologics (biosimilars) in the United States.
Clin Pharmacol Ther. 2010 Feb; 87(2):157-9.CP

Abstract

As Congress begins drafting legislation concerning the US Food and Drug Administration (FDA) regulation of biosimilars, it is critical to keep in mind that these agents may differ from their innovator compounds. Therefore, it is of the utmost importance to be able to differentiate among innovators and biosimilars in administrative data in order to facilitate the conduct of population-based safety and comparative effectiveness studies. This Commentary proposes methods that would allow these agents to be distinguished in such data.

Authors+Show Affiliations

University of Pennsylvania Center for Education and Research on Therapeutics and Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania, USA. hennessy@upenn.eduNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

20107450

Citation

Hennessy, S, et al. "Assessing the Safety and Comparative Effectiveness of Follow-on Biologics (biosimilars) in the United States." Clinical Pharmacology and Therapeutics, vol. 87, no. 2, 2010, pp. 157-9.
Hennessy S, Leonard CE, Platt R. Assessing the safety and comparative effectiveness of follow-on biologics (biosimilars) in the United States. Clin Pharmacol Ther. 2010;87(2):157-9.
Hennessy, S., Leonard, C. E., & Platt, R. (2010). Assessing the safety and comparative effectiveness of follow-on biologics (biosimilars) in the United States. Clinical Pharmacology and Therapeutics, 87(2), 157-9. https://doi.org/10.1038/clpt.2009.249
Hennessy S, Leonard CE, Platt R. Assessing the Safety and Comparative Effectiveness of Follow-on Biologics (biosimilars) in the United States. Clin Pharmacol Ther. 2010;87(2):157-9. PubMed PMID: 20107450.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Assessing the safety and comparative effectiveness of follow-on biologics (biosimilars) in the United States. AU - Hennessy,S, AU - Leonard,C E, AU - Platt,R, PY - 2010/1/29/entrez PY - 2010/1/29/pubmed PY - 2010/2/19/medline SP - 157 EP - 9 JF - Clinical pharmacology and therapeutics JO - Clin. Pharmacol. Ther. VL - 87 IS - 2 N2 - As Congress begins drafting legislation concerning the US Food and Drug Administration (FDA) regulation of biosimilars, it is critical to keep in mind that these agents may differ from their innovator compounds. Therefore, it is of the utmost importance to be able to differentiate among innovators and biosimilars in administrative data in order to facilitate the conduct of population-based safety and comparative effectiveness studies. This Commentary proposes methods that would allow these agents to be distinguished in such data. SN - 1532-6535 UR - https://www.unboundmedicine.com/medline/citation/20107450/Assessing_the_safety_and_comparative_effectiveness_of_follow_on_biologics__biosimilars__in_the_United_States_ L2 - https://doi.org/10.1038/clpt.2009.249 DB - PRIME DP - Unbound Medicine ER -