Literature DB >> 28781504

FDA Guidance on Biosimilar Interchangeability Elicits Diverse Views: Current and Potential Marketers Complain About Too-High Hurdles.

Stephen Barlas.   

Abstract

Pharmaceutical industry sectors are at odds as the Food and Drug Administration seeks to define "interchangeability" for biosimilars. The battle lines vary by topic, but biosimilar marketers, health plans, and drugstores are generally urging lower hurdles.

Year:  2017        PMID: 28781504      PMCID: PMC5521299     

Source DB:  PubMed          Journal:  P T        ISSN: 1052-1372


  3 in total

1.  Long-term efficacy, safety and immunogenicity in patients with rheumatoid arthritis continuing on an etanercept biosimilar (LBEC0101) or switching from reference etanercept to LBEC0101: an open-label extension of a phase III multicentre, randomised, double-blind, parallel-group study.

Authors:  Min-Chan Park; Hiroaki Matsuno; Jinseok Kim; Sung-Hwan Park; Sang-Heon Lee; Yong-Beom Park; Yun Jong Lee; Sang-Il Lee; Won Park; Dong Hyuk Sheen; Jung-Yoon Choe; Chan-Bum Choi; Seung-Jae Hong; Chang-Hee Suh; Shin-Seok Lee; Hoon-Suk Cha; Bin Yoo; Jin-Wuk Hur; Geun-Tae Kim; Wan-Hee Yoo; Han Joo Baek; Kichul Shin; Seung Cheol Shim; Hyung-In Yang; Hyun Ah Kim; Kyung-Su Park; In Ah Choi; Jisoo Lee; Masato Tomomitsu; Seonghye Shin; Jiyoon Lee; Yeong Wook Song
Journal:  Arthritis Res Ther       Date:  2019-05-21       Impact factor: 5.156

2.  Effectiveness and Safety of Switching Originator and Biosimilar Epoetins in Patients with Chronic Kidney Disease in a Large-Scale Italian Cohort Study.

Authors:  Valeria Belleudi; Francesco Trotta; Antonio Addis; Ylenia Ingrasciotta; Valentina Ientile; Michele Tari; Rosa Gini; Maurizio Pastorello; Salvatore Scondotto; Pasquale Cananzi; Giuseppe Traversa; Marina Davoli; Gianluca Trifirò
Journal:  Drug Saf       Date:  2019-12       Impact factor: 5.606

Review 3.  Interchangeability of Biosimilars: What Level of Clinical Evidence is Needed to Support the Interchangeability Designation in the United States?

Authors:  Daniel F Alvarez; Gertjan Wolbink; Carol Cronenberger; John Orazem; Jonathan Kay
Journal:  BioDrugs       Date:  2020-12       Impact factor: 5.807

  3 in total

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