Articles

Original Research

Published on 03 July 2014

Barriers to market uptake of biosimilars in the US

Author byline as per print journal: Joshua P Cohen, PhD; Abigail E Felix, BA; Kim Riggs, MPH; Anumeha Gupta, MD Background: In the US, a new approval pathway for biosimilars has been established...

Author(s): Abigail E Felix, BA, Anumeha Gupta, MD, Joshua P Cohen, PhD, Kim Riggs, MPH

biosimilar, formulary, interchangeability, originator biological, payers, price discount, therapeutic switching

DOI: 10.5639/gabij.2014.0303.028

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Special Report

Published on 23 January 2017

Patent expiry dates for biologicals: 2016 update

Abstract: Biosimilars have been approved in Europe since 2006 and in the US since 2015. With patents on originator biologicals expiring and ever-tightening healthcare budgets, biosimilars are expected to take...

Author(s): GaBI Journal Editor

biological, biosimilar, patent

DOI: 10.5639/gabij.2017.0601.006

27.043 views

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Editorial

Published on 14 February 2012

Generic medicine pricing: on track in Europe?

Abstract: There are many variables responsible for the pricing of generic medicines in Europe. This editorial looks at the many policy initiatives currently being undertaken. Submitted: 3 November 2011; Revised...

Author(s): Associate Professor Marc A Koopmanschap, PhD

DOI: 10.5639/gabij.2012.0101.002

26.762 views

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Review Article

Published on 11 October 2012

Biosimilars in the European market

Author byline as per print journal: Professor Joan Rovira, PhD; Leandro Lindner, BSc; Emmanuel Giménez, BSc; Professor Jaime Espín, PhD; Antonio Olry de Labry, PhD; Leticia García, BSc Introduction and...

Author(s): Antonio Olry de Labry, PhD, Emmanuel Giménez, BSc, Leandro Lindner, BSc, Leticia García, BSc, Professor Jaime Espín, PhD, Professor Joan Rovira, PhD

biosimilars, European Union, market dynamics

DOI: 10.5639/gabij.2013.0201.012

26.669 views

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Original Research

Published on 24 April 2013

Assessing biosimilarity using the method of generalized pivotal quantities

Author byline as per print journal: Shih-Ting Chiu, PhD, Chen Chen, MSc, Professor Shein-Chung Chow, PhD, Eric Chi, PhD Introduction: For generic approval of small-molecule (chemical) drug products, US Food...

Author(s): et al., Shih-Ting Chiu, MSc

extra-reference design, generalized pivotal quantity, individual bioequivalence, replicated crossover design

DOI: 10.5639/gabij.2013.0203.037

26.663 views

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Editorial

Published on 02 August 2012

Generics policies–a globally-relevant implementation challenge

Abstract:  Vogler and Zimmerman, reporting on the 2011 Pharmaceutical Pricing and Reimbursement Information (PPRI) Conference, have noted the incomplete application of generics policies in many settings, and have called for...

Author(s): Andy Gray, MScPharm, FPS, FFIP

generics policies, transparency, WHO policy

DOI: 10.5639/gabij.2012.0103-4.027

26.515 views

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Perspective

Published on 18 November 2013

Role of hospital clinical pharmacist in transplantation, and generic immunosuppressive therapies

Abstract: The pharmacist is an important patient advocate in the transplant multidisciplinary team and can support patients in their medication taking to improve medication adherence. Medicine optimization and patient information...

Author(s): Andrea Devaney

generics substitution, immunosuoppressives, self-medication, tacrolimus, transplantation

DOI: 10.5639/gabij.2014.0302.023

26.178 views

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Review Article

Published on 05 January 2021

Continuous manufacturing versus batch manufacturing: benefits, opportunities and challenges for manufacturers and regulators

Author byline as per print journal: Adjunct Associate Professor Sia Chong Hock, BSc (Pharm), MSc; Teh Kee Siang, BSc (Pharm)(Hon); Associate Professor Chan Lai Wah, BSc (Pharm)(Hon), PhD Continuous manufacturing...

batch manufacturing, challenges, continuous manufacturing, harmonization, opportunity, regulatory

DOI: 10.5639/gabij.2021.1001.004

26.124 views

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Review Article

Published on 22 November 2012

Current status of biopharmaceuticals in Iran’s pharmaceutical market

Abstract: The clinical importance of biopharmaceuticals for the management of life threatening diseases is increasing but costs have become a major obstacle to the administration of these medicines, especially in...

Author(s): Professor Abdol Majid Cheraghali, PharmaD, PhD

biopharmaceuticals, biosimilars, Iran, pharmacovigilance

DOI: 10.5639/gabij.2013.0201.008

26.121 views

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Conference Report

Published on 12 November 2012

Recent trends and special topics in new drug review in PMDA

Abstract: The Pharmaceuticals and Medical Devices Agency (PMDA) is Japan’s regulatory agency, which works together with the Ministry of Health, Labour and Welfare. At the 24th Drug Information Association Annual...

Author(s): Toshiki Sugita, PhD

approval review, global clinical trials, Japanese regulatory authority, PMDA, prior assessment consultation

DOI: 10.5639/gabij.2013.0202.024

26.000 views

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