Literature DB >> 28230453

Letter--Draft FDA Guidance "Considerations in Demonstrating Interchangeability with a Reference Product": Overview and Presentation-Related Concerns.

Elan Rubinstein1.   

Abstract

DISCLOSURES: Rubinstein provides consulting services to the pharmaceutical industry, health plans, employers, and specialty pharmacies, and is a member of the editorial advisory board of Specialty Pharmacy News. He was a participant on the Amgen Biosimilar Report Advisory Board and reports consulting fees from Amgen.

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Year:  2017        PMID： 28230453     DOI： 10.18553/jmcp.2017.23.3.266

Source DB:  PubMed          Journal:  J Manag Care Spec Pharm


  10 in total

1.  Pharmacotherapy: Biosimilar switching - "To set a form upon desired change".

Authors:  Jonathan Kay; Kevin L Winthrop
Journal:  Nat Rev Rheumatol       Date:  2017-06-01       Impact factor: 20.543

2.  Therapy: Biosimilars in rheumatology - why, how and when in 2017.

Authors:  Roy Fleischmann
Journal:  Nat Rev Rheumatol       Date:  2017-11-03       Impact factor: 20.543

3.  Biosimilars for the treatment of patients with psoriasis: A consensus statement from the Biosimilar Working Group of the International Psoriasis Council.

Authors:  Arnon D Cohen; Ronald Vender; Luigi Naldi; Robert E Kalb; Tiago Torres; Murlidhar Rajagopalan; Joelle van der Walt; Lluís Puig; Helen S Young
Journal:  JAAD Int       Date:  2020-11-23

4.  [Revised version of the statement by the DGRh on biosimilars-update 2017].

Authors:  J Braun; H M Lorenz; U Müller-Ladner; M Schneider; H Schulze-Koops; Ch Specker; A Strangfeld; U Wagner; T Dörner
Journal:  Z Rheumatol       Date:  2018-02       Impact factor: 1.372

Review 5.  Novel Therapies and Treatment Strategies for Patients with Inflammatory Bowel Disease.

Authors:  Marjolijn Duijvestein; Robert Battat; Niels Vande Casteele; Geert R D'Haens; William J Sandborn; Reena Khanna; Vipul Jairath; Brian G Feagan
Journal:  Curr Treat Options Gastroenterol       Date:  2018-03

6.  Switching from originator biological agents to biosimilars: what is the evidence and what are the issues?

Authors:  Eric Toussirot; Hubert Marotte
Journal:  RMD Open       Date:  2017-09-12

Review 7.  Biosimilar switching - current state of knowledge.

Authors:  Piotr Wiland; Bogdan Batko; Marek Brzosko; Eugeniusz J Kucharz; Włodzimierz Samborski; Jerzy Świerkot; Ewa Więsik-Szewczyk; Julia Feldman
Journal:  Reumatologia       Date:  2018-08-31

8.  Insulins as Drugs or Biologics in the USA: What Difference Does it Make and Why Does it Matter?

Authors:  Kelly George; Gillian Woollett
Journal:  BioDrugs       Date:  2019-10       Impact factor: 5.807

Review 9.  Quality, Non-clinical and Clinical Considerations for Biosimilar Monoclonal Antibody Development: EU, WHO, USA, Canada, and BRICS-TM Regulatory Guidelines.

Authors:  Hasumati Rahalkar; Hacer Coskun Cetintas; Sam Salek
Journal:  Front Pharmacol       Date:  2018-09-28       Impact factor: 5.810

Review 10.  The biosimilars journey: current status and ongoing challenges.

Authors:  Igor Age Kos; Valderílio Feijó Azevedo; Daniel Egg Neto; Sérgio Cândido Kowalski
Journal:  Drugs Context       Date:  2018-10-01
  10 in total

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