Literature DB >> 19286455

Biosimilars--science, status, and strategic perspective.

Georg-Burkhard Kresse1.   

Abstract

Biopharmaceuticals based on recombinant proteins have started to go off-patent, opening the way for other manufacturers to place follow-on products to the market. Meanwhile it has been recognized by all stakeholders that there are fundamental differences between conventional small-molecule based drugs and biopharmaceuticals. This has led to the adoption of distinct legal and regulatory frameworks for biosimilars (follow-on products to biopharmaceuticals) in various parts of the world. This review gives an overview on the scientific basis for the approval requirements, the regulatory and market status, open issues, and the strategic perspective.

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Year:  2009        PMID： 19286455     DOI： 10.1016/j.ejpb.2009.02.014

Source DB:  PubMed          Journal:  Eur J Pharm Biopharm        ISSN： 0939-6411            Impact factor:   5.571


  9 in total

1.  Interchangeability, immunogenicity and biosimilars.

Authors:  Hans C Ebbers; Stacy A Crow; Arnold G Vulto; Huub Schellekens
Journal:  Nat Biotechnol       Date:  2012-12       Impact factor: 54.908

2.  Nucleic acid aptamers as stabilizers of proteins: the stability of tetanus toxoid.

Authors:  Nishant Kumar Jain; Hardik C Jetani; Ipsita Roy
Journal:  Pharm Res       Date:  2013-04-09       Impact factor: 4.200

Review 3.  The Concept of Biosimilars: From Characterization to Evolution-A Narrative Review.

Authors:  Fadi Farhat; Alfredo Torres; Wungki Park; Gilberto de Lima Lopes; Raja Mudad; Chukwuemeka Ikpeazu; Simon Abi Aad
Journal:  Oncologist       Date:  2017-12-28

Review 4.  Emerging Strategies for Developing Next-Generation Protein Therapeutics for Cancer Treatment.

Authors:  James R Kintzing; Maria V Filsinger Interrante; Jennifer R Cochran
Journal:  Trends Pharmacol Sci       Date:  2016-11-09       Impact factor: 14.819

5.  The emerging process of Top Down mass spectrometry for protein analysis: biomarkers, protein-therapeutics, and achieving high throughput.

Authors:  John F Kellie; John C Tran; Ji Eun Lee; Dorothy R Ahlf; Haylee M Thomas; Ioanna Ntai; Adam D Catherman; Kenneth R Durbin; Leonid Zamdborg; Adaikkalam Vellaichamy; Paul M Thomas; Neil L Kelleher
Journal:  Mol Biosyst       Date:  2010-03-29

6.  Biosimilar Insulins: Basic Considerations.

Authors:  Lutz Heinemann; Marcus Hompesch
Journal:  J Diabetes Sci Technol       Date:  2014-01-01

Review 7.  Biopharmaceuticals from microorganisms: from production to purification.

Authors:  Angela Faustino Jozala; Danilo Costa Geraldes; Louise Lacalendola Tundisi; Valker de Araújo Feitosa; Carlos Alexandre Breyer; Samuel Leite Cardoso; Priscila Gava Mazzola; Laura de Oliveira-Nascimento; Carlota de Oliveira Rangel-Yagui; Pérola de Oliveira Magalhães; Marcos Antonio de Oliveira; Adalberto Pessoa
Journal:  Braz J Microbiol       Date:  2016-10-26       Impact factor: 2.476

8.  Review and results of a survey about biosimilars prescription and challenges in the Middle East and North Africa region.

Authors:  Fadi Farhat; Ahmad Othman; Fadi El Karak; Joseph Kattan
Journal:  Springerplus       Date:  2016-12-30

Review 9.  Biosimilars: Key regulatory considerations and similarity assessment tools.

Authors:  Carol F Kirchhoff; Xiao-Zhuo Michelle Wang; Hugh D Conlon; Scott Anderson; Anne M Ryan; Arindam Bose
Journal:  Biotechnol Bioeng       Date:  2017-09-19       Impact factor: 4.530
  9 in total

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