Literature DB >> 21812668

Developing the nation's biosimilars program.

Steven Kozlowski1, Janet Woodcock, Karen Midthun, Rachel Behrman Sherman.   

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Year:  2011        PMID： 21812668     DOI： 10.1056/NEJMp1107285

Source DB:  PubMed          Journal:  N Engl J Med        ISSN： 0028-4793            Impact factor:   91.245


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  46 in total

1.  What's fueling the biotech engine--2010 to 2011.

Authors:  Saurabh Aggarwal
Journal:  Nat Biotechnol       Date:  2011-12-08       Impact factor: 54.908

Review 2.  The cost-effectiveness of biopharmaceuticals: a look at the evidence.

Authors:  Andrew W Wilson; Peter J Neumann
Journal:  MAbs       Date:  2012-03-01       Impact factor: 5.857

Review 3.  The advent of biosimilar therapies in rheumatology--"O brave new world".

Authors:  Morton A Scheinberg; Jonathan Kay
Journal:  Nat Rev Rheumatol       Date:  2012-06-05       Impact factor: 20.543

4.  Innovation and Competition: Will Biosimilars Succeed?: The creation of an FDA approval pathway for biosimilars is complex and fraught with hazard. Yes, innovation and market competition are at stake. But so are efficacy and patient safety.

Authors:  Erwin A Blackstone; Joseph P Fuhr
Journal:  Biotechnol Healthc       Date:  2012

5.  Safety Profile of Biosimilar Filgrastim (Zarzio/Zarxio): A Combined Analysis of Phase III Studies.

Authors:  Nadia Harbeck; Pere Gascón; Andriy Krendyukov; Nadja Hoebel; Sreekanth Gattu; Kimberly Blackwell
Journal:  Oncologist       Date:  2018-01-09

Review 6.  Generics, chemisimilars and biosimilars: is clinical testing fit for purpose?

Authors:  John B Warren
Journal:  Br J Clin Pharmacol       Date:  2013-01       Impact factor: 4.335

7.  Pharmacokinetics and toxicology of therapeutic proteins: Advances and challenges.

Authors:  Yulia Vugmeyster; Xin Xu; Frank-Peter Theil; Leslie A Khawli; Michael W Leach
Journal:  World J Biol Chem       Date:  2012-04-26

8.  Why an abbreviated FDA pathway for biosimilars is overhyped.

Authors:  Henry I Miller
Journal:  Nat Biotechnol       Date:  2011-09-08       Impact factor: 54.908

Review 9.  Regulatory and clinical considerations for biosimilar oncology drugs.

Authors:  Charles L Bennett; Brian Chen; Terhi Hermanson; Michael D Wyatt; Richard M Schulz; Peter Georgantopoulos; Samuel Kessler; Dennis W Raisch; Zaina P Qureshi; Z Kevin Lu; Bryan L Love; Virginia Noxon; Laura Bobolts; Melissa Armitage; John Bian; Paul Ray; Richard J Ablin; William J Hrushesky; Iain C Macdougall; Oliver Sartor; James O Armitage
Journal:  Lancet Oncol       Date:  2014-11-24       Impact factor: 41.316

10.  Formulary Selection Criteria for Biosimilars: Considerations for US Health-System Pharmacists.

Authors:  Niesha Griffith; Ali McBride; James G Stevenson; Larry Green
Journal:  Hosp Pharm       Date:  2014-10
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