Literature DB >> 27990042

Safety considerations of biosimilars.

Ross McKinnon1, Michael Ward2.   

Abstract

Entities:  

Keywords:  bioequivalence; biologic drug; biosimilar drug; generic drug; monoclonal antibody

Year:  2016        PMID： 27990042      PMCID： PMC5155057          DOI： 10.18773/austprescr.2016.084

Source DB:  PubMed          Journal:  Aust Prescr        ISSN： 0312-8008


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  8 in total

1.  Identifying and Quantifying the Accuracy of Product Name Attribution of US-Sourced Adverse Event Reports in MedWatch of Somatropins and Insulins.

Authors:  Stella Stergiopoulos; Carrie A Brown; Gustavo Grampp; Thomas Felix; Kenneth A Getz
Journal:  Ther Innov Regul Sci       Date:  2015-09       Impact factor: 1.778

2.  Viewpoint: knowledge and viewpoints on biosimilar monoclonal antibodies among members of the European Crohn's and Colitis Organization.

Authors:  Silvio Danese; Gionata Fiorino; Pierre Michetti
Journal:  J Crohns Colitis       Date:  2014-07-06       Impact factor: 9.071

3.  Changes in Biosimilar Knowledge among European Crohn's Colitis Organization [ECCO] Members: An Updated Survey.

Authors:  Silvio Danese; Gionata Fiorino; Pierre Michetti
Journal:  J Crohns Colitis       Date:  2016-04-25       Impact factor: 9.071

Review 4.  Clinical experience with infliximab biosimilar Remsima (CT-P13) in inflammatory bowel disease patients.

Authors:  Jørgen Jahnsen
Journal:  Therap Adv Gastroenterol       Date:  2016-03-21       Impact factor: 4.409

5.  Biosimilar recombinant human erythropoietin induces the production of neutralizing antibodies.

Authors:  Kearkiat Praditpornsilpa; Khajohn Tiranathanagul; Pawinee Kupatawintu; Saengsuree Jootar; Tanin Intragumtornchai; Kriang Tungsanga; Tanyarat Teerapornlertratt; Dusit Lumlertkul; Natavudh Townamchai; Paweena Susantitaphong; Pisut Katavetin; Talerngsak Kanjanabuch; Yingyos Avihingsanon; Somchai Eiam-Ong
Journal:  Kidney Int       Date:  2011-03-23       Impact factor: 10.612

6.  Efficacy and safety of CT-P13 (biosimilar infliximab) in patients with rheumatoid arthritis: comparison between switching from reference infliximab to CT-P13 and continuing CT-P13 in the PLANETRA extension study.

Authors:  Dae Hyun Yoo; Nenad Prodanovic; Janusz Jaworski; Pedro Miranda; Edgar Ramiterre; Allan Lanzon; Asta Baranauskaite; Piotr Wiland; Carlos Abud-Mendoza; Boycho Oparanov; Svitlana Smiyan; HoUng Kim; Sang Joon Lee; SuYeon Kim; Won Park
Journal:  Ann Rheum Dis       Date:  2016-04-29       Impact factor: 19.103

7.  Efficacy and safety of switching from reference infliximab to CT-P13 compared with maintenance of CT-P13 in ankylosing spondylitis: 102-week data from the PLANETAS extension study.

Authors:  Won Park; Dae Hyun Yoo; Pedro Miranda; Marek Brzosko; Piotr Wiland; Sergio Gutierrez-Ureña; Helena Mikazane; Yeon-Ah Lee; Svitlana Smiyan; Mie-Jin Lim; Vladimir Kadinov; Carlos Abud-Mendoza; HoUng Kim; Sang Joon Lee; YunJu Bae; SuYeon Kim; Jürgen Braun
Journal:  Ann Rheum Dis       Date:  2016-04-26       Impact factor: 19.103

8.  A phase III randomised, double-blind, parallel-group study comparing SB4 with etanercept reference product in patients with active rheumatoid arthritis despite methotrexate therapy.

Authors:  Paul Emery; Jiří Vencovský; Anna Sylwestrzak; Piotr Leszczyński; Wieslawa Porawska; Asta Baranauskaite; Vira Tseluyko; Vyacheslav M Zhdan; Barbara Stasiuk; Roma Milasiene; Aaron Alejandro Barrera Rodriguez; Soo Yeon Cheong; Jeehoon Ghil
Journal:  Ann Rheum Dis       Date:  2015-07-06       Impact factor: 19.103
  8 in total
  4 in total

Review 1.  Generic Substitution of Orphan Drugs for the Treatment of Rare Diseases: Exploring the Potential Challenges.

Authors:  Antonello Di Paolo; Elena Arrigoni
Journal:  Drugs       Date:  2018-03       Impact factor: 9.546

Review 2.  Pharmacovigilance of biosimilars - Why is it different from generics and innovator biologics?

Authors:  B Oza; S Radhakrishna; P Pipalava; V Jose
Journal:  J Postgrad Med       Date:  2019 Oct-Dec       Impact factor: 1.476

3.  The Economic Impact of Originator-to-Biosimilar Non-medical Switching in the Real-World Setting: A Systematic Literature Review.

Authors:  Erin Hillhouse; Karine Mathurin; Joëlle Bibeau; Diana Parison; Yasmine Rahal; Jean Lachaine; Catherine Beauchemin
Journal:  Adv Ther       Date:  2021-11-15       Impact factor: 3.845

4.  Identifying biosimilar side effects: Infliximab-dyyb-associated subcorneal pustular dermatosis.

Authors:  Maria Amoreth R Gozo; Iviensan F Manalo; Tunisia Cornelius
Journal:  Int J Womens Dermatol       Date:  2020-12-10
  4 in total

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