Literature DB >> 23222784

Interchangeability, immunogenicity and biosimilars.

Hans C Ebbers1, Stacy A Crow, Arnold G Vulto, Huub Schellekens.   

Abstract

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Year:  2012        PMID： 23222784     DOI： 10.1038/nbt.2438

Source DB:  PubMed          Journal:  Nat Biotechnol        ISSN： 1087-0156            Impact factor:   54.908


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  24 in total

Review 1.  Biosimilars and regulatory authorities.

Authors:  Paola Minghetti; Paolo Rocco; Lucia Del Vecchio; Francesco Locatelli
Journal:  Nephron Clin Pract       Date:  2010-08-03

2.  Risk Management Plans: are they a tool for improving drug safety?

Authors:  Serena Frau; Maria Font Pous; Maria Rosa Luppino; Anita Conforti
Journal:  Eur J Clin Pharmacol       Date:  2010-06-25       Impact factor: 2.953

3.  Acceptable changes in quality attributes of glycosylated biopharmaceuticals.

Authors:  Martin Schiestl; Thomas Stangler; Claudia Torella; Tadej Cepeljnik; Hansjörg Toll; Roger Grau
Journal:  Nat Biotechnol       Date:  2011-04       Impact factor: 54.908

Review 4.  The safety of switching between therapeutic proteins.

Authors:  Hans C Ebbers; Michael Muenzberg; Huub Schellekens
Journal:  Expert Opin Biol Ther       Date:  2012-07-31       Impact factor: 4.388

5.  Randomized trial of darbepoetin alfa for treatment of renal anemia at a reduced dose frequency compared with rHuEPO in dialysis patients.

Authors:  Yves Vanrenterghem; Peter Bárány; Johannes F E Mann; Peter G Kerr; Janet Wilson; Nigel F Baker; Stephen J Gray
Journal:  Kidney Int       Date:  2002-12       Impact factor: 10.612

6.  Epoetin alfa and beta differ in their erythropoietin isoform compositions and biological properties.

Authors:  P L Storring; R J Tiplady; R E Gaines Das; B E Stenning; A Lamikanra; B Rafferty; J Lee
Journal:  Br J Haematol       Date:  1998-01       Impact factor: 6.998

7.  Tungsten-induced denaturation and aggregation of epoetin alfa during primary packaging as a cause of immunogenicity.

Authors:  Andreas Seidl; Otmar Hainzl; Marleen Richter; Robert Fischer; Stephan Böhm; Britta Deutel; Martin Hartinger; Jörg Windisch; Nicole Casadevall; Gerard Michel London; Iain Macdougall
Journal:  Pharm Res       Date:  2011-11-18       Impact factor: 4.200

8.  Generic and therapeutic substitutions in the UK: are they a good thing?

Authors:  Martin G Duerden; Dyfrig A Hughes
Journal:  Br J Clin Pharmacol       Date:  2010-09       Impact factor: 4.335

9.  A peptide-based erythropoietin-receptor agonist for pure red-cell aplasia.

Authors:  Iain C Macdougall; Jerome Rossert; Nicole Casadevall; Richard B Stead; Anne-Marie Duliege; Marc Froissart; Kai-Uwe Eckardt
Journal:  N Engl J Med       Date:  2009-11-05       Impact factor: 91.245

Review 10.  Biosimilar agents in oncology/haematology: from approval to practice.

Authors:  Dietger Niederwieser; Stephan Schmitz
Journal:  Eur J Haematol       Date:  2011-01-25       Impact factor: 2.997
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  19 in total

1.  [Regulatory aspects of biosimilars. Myths and facts].

Authors:  C K Schneider; M Weise
Journal:  Z Rheumatol       Date:  2015-10       Impact factor: 1.372

2.  The constrained prescription, interchangeability and substitution of biosimilars.

Authors:  Paola Minghetti; Paolo Rocco; Huub Schellekens
Journal:  Nat Biotechnol       Date:  2015-07       Impact factor: 54.908

Review 3.  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

Review 4.  Biosimilars in IBD: from theory to practice.

Authors:  Silvio Danese; Stefanos Bonovas; Laurent Peyrin-Biroulet
Journal:  Nat Rev Gastroenterol Hepatol       Date:  2016-10-12       Impact factor: 46.802

Review 5.  Monitoring Quality of Biotherapeutic Products Using Multivariate Data Analysis.

Authors:  Anurag S Rathore; Mili Pathak; Renu Jain; Gaurav Pratap Singh Jadaun
Journal:  AAPS J       Date:  2016-04-04       Impact factor: 4.009

6.  Safety, efficacy and immunogenicity of switching from innovator to biosimilar infliximab in patients with spondyloarthritis: a 6-month real-life observational study.

Authors:  Maurizio Benucci; Francesca Li Gobbi; Francesca Bandinelli; Arianna Damiani; Maria Infantino; Valentina Grossi; Mariangela Manfredi; Simone Parisi; Enrico Fusaro; Alberto Batticciotto; Piercarlo Sarzi-Puttini; Fabiola Atzeni; Francesca Meacci
Journal:  Immunol Res       Date:  2017-02       Impact factor: 2.829

7.  Statistical and regulatory considerations in assessments of interchangeability of biological drug products.

Authors:  Lászlo Tóthfalusi; László Endrényi; Shein-Chung Chow
Journal:  Eur J Health Econ       Date:  2014-05-16

Review 8.  Standardizing terms, definitions and concepts for describing and interpreting unwanted immunogenicity of biopharmaceuticals: recommendations of the Innovative Medicines Initiative ABIRISK consortium.

Authors:  B Rup; M Pallardy; D Sikkema; T Albert; M Allez; P Broet; C Carini; P Creeke; J Davidson; N De Vries; D Finco; A Fogdell-Hahn; E Havrdova; A Hincelin-Mery; M C Holland; P E H Jensen; E C Jury; H Kirby; D Kramer; S Lacroix-Desmazes; J Legrand; E Maggi; B Maillère; X Mariette; C Mauri; V Mikol; D Mulleman; J Oldenburg; G Paintaud; C R Pedersen; N Ruperto; R Seitz; S Spindeldreher; F Deisenhammer
Journal:  Clin Exp Immunol       Date:  2015-07-02       Impact factor: 4.330

9.  Interlaboratory Study for Characterizing Monoclonal Antibodies by Top-Down and Middle-Down Mass Spectrometry.

Authors:  Kristina Srzentić; Luca Fornelli; Yury O Tsybin; Joseph A Loo; Henrique Seckler; Jeffrey N Agar; Lissa C Anderson; Dina L Bai; Alain Beck; Jennifer S Brodbelt; Yuri E M van der Burgt; Julia Chamot-Rooke; Sneha Chatterjee; Yunqiu Chen; David J Clarke; Paul O Danis; Jolene K Diedrich; Robert A D'Ippolito; Mathieu Dupré; Natalia Gasilova; Ying Ge; Young Ah Goo; David R Goodlett; Sylvester Greer; Kim F Haselmann; Lidong He; Christopher L Hendrickson; Joshua D Hinkle; Matthew V Holt; Sam Hughes; Donald F Hunt; Neil L Kelleher; Anton N Kozhinov; Ziqing Lin; Christian Malosse; Alan G Marshall; Laure Menin; Robert J Millikin; Konstantin O Nagornov; Simone Nicolardi; Ljiljana Paša-Tolić; Stuart Pengelley; Neil R Quebbemann; Anja Resemann; Wendy Sandoval; Richa Sarin; Nicholas D Schmitt; Jeffrey Shabanowitz; Jared B Shaw; Michael R Shortreed; Lloyd M Smith; Frank Sobott; Detlev Suckau; Timothy Toby; Chad R Weisbrod; Norelle C Wildburger; John R Yates; Sung Hwan Yoon; Nicolas L Young; Mowei Zhou
Journal:  J Am Soc Mass Spectrom       Date:  2020-08-19       Impact factor: 3.109

10.  Comparing the biological impact of glatiramer acetate with the biological impact of a generic.

Authors:  Fadi Towfic; Jason M Funt; Kevin D Fowler; Shlomo Bakshi; Eran Blaugrund; Maxim N Artyomov; Michael R Hayden; David Ladkani; Rivka Schwartz; Benjamin Zeskind
Journal:  PLoS One       Date:  2014-01-08       Impact factor: 3.240
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