Most Read Articles

National and regional activities by sickness funds in Austria to encourage the rational use of medicines

Abstract: Dr Brian Godman reviews the paper by Vogler and Zimmermann on sickness fund activity in Austria to preferentially encourage the prescribing of generics. This is particularly important given the… Read More »

The generic pharmaceutical industry: moving beyond incremental innovation towards re-innovation

Background: Due to the declining innovativeness of the classic R & D model in the original pharmaceutical industry, the generic pharmaceutical industry is aiming to become an innovation generator itself.… Read More »

A review of generic medicine pricing in Europe

Introduction: Switching from originator products to generic equivalents is a key method used by governments to reduce costs and keep their healthcare systems sustainable. The aim of this article is… Read More »

Biosimilars patent litigation in the EU and the US: a comparative strategic overview

Abstract: Biosimilars are highly similar versions of reference biological products, some with the potential to be deemed ‘interchangeable’ by regulatory bodies, such as the US Food and Drug Administration. Biosimilar… Read More »

Myths, questions, facts about generic drugs in the EU

Abstract: Many generic drugs are now being prescribed and the trend is increasing. For example, in Austria, the number of all generics prescriptions has more than doubled from 11% in… Read More »

Reference pricing systems in Europe: characteristics and consequences

Author byline as per print journal: Pieter Dylst, PharmD; Professor Steven Simoens, MSc, PhD; Professor Arnold G Vulto, PharmD, PhD Introduction: A reference pricing system is a system that establishes a common reimbursement level… Read More »

The refinement of the super generic concept: semantic challenge for product re-innovation?

Background: Uptake of super generic or hybrid pharmaceuticals has decelerated despite their important economic potential for the generic pharmaceutical industry. The aim of switching to these product portfolios was to… Read More »

What lessons can be learned from the launch of generic clopidogrel?

Author byline as per print journal: Christoph Baumgärtel1, MD; Brian Godman2,3,4, BSc, PhD; Rickard E Malmstrom5, MD, PhD; Morten Andersen6, MD, PhD; Mohammed Abuelkhair7, PharmD; Shajahan Abdu7, MD; Marion Bennie8,9, MSc;… Read More »

Where does the value of ‘value-added’ pharmaceuticals come from?

Abstract: The role of sound science, discovery, and innovation in value-added pharmaceuticals has not been sufficiently considered. This term is mainly used to define improved version of generic drugs. The… Read More »

European payer initiatives to reduce prescribing costs through use of generics

Author byline as per print journal:  Brian Godman1,2,3, BSc, PhD; Bjorn Wettermark1,4, MSc, PhD; Iain Bishop5, BSc; Thomas Burkhardt6, MSc; Jurij Fürst7, PhD; Kristina Garuoliene8, MD; Ott Laius9, MScPharm; Jaana E Martikainen10,… Read More »

Biologicals and biosimilars: a review of the science and its implications

Abstract: Biopharmaceuticals are medicines whose active drug substance is made by living cells. Copies of these drugs, called biosimilars, are not identical to their reference drug and therefore specific regulatory… Read More »

The impact of pharmaceutical pricing and reimbursement policies on generics uptake: implementation of policy options on generics in 29 European countries─an overview

Introduction: To describe pharmaceutical pricing and reimbursement systems in 29 European countries with regard to medicines, particularly generics, and their possible impact on generics uptake. Method: Data collection on pharmaceutical pricing and… Read More »

Biosimilars versus ‘biobetters’—a regulator’s perspective

Abstract: The attractiveness of the biosimilar regulatory pathway is threatened by so-called biobetters. This paper provides definitions and an overview of recent developments. Submitted: 27 October 2014; Revised: 7 November… Read More »

Regulations for biotherapeutics approval in Colombia

Author byline as per print journal: Johanna Andrea García Cortes, MSc; Francisco Javier Sierra Esteban, MSc Abstract: Colombia is in the process of implementing legislation to allow for the approval… Read More »

A patient-centred paradigm for the biosimilars market

Abstract: The advent of similar biological medicinal products or ‘biosimilars’ in Europe in the 2000s has led to development of a global biosimilars market and regulatory frameworks designed specifically for… Read More »

Understanding the components of pharmaceutical expenditure—overview of pharmaceutical policies influencing expenditure across European countries

Aim: To explain the components of pharmaceutical expenditure and illustrate the strengths and limitations of this indicator. In particular, we explore policies applied in European countries that affect the price… Read More »

Generic clopidogrel–the medicines agency’s perspective

Abstract:  A number of generic products containing clopidogrel as the active substance have been marketed in Austria and the EU for some time. Due to different clopidogrel salt preparations and different indications, doubts… Read More »

Equal protection under the law: Children and the Best Pharmaceuticals for Children Act

Abstract:  Four changes to the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act will markedly improve these programmes: expanded attention paid to neonatal studies, support for the… Read More »

Immunogenicity of biosimilar monoclonal antibodies

Abstract: Biosimilar monoclonal antibodies (mAbs) are making their way onto the drug market. Because these are complex molecules in terms of structure and function, assessing similarity between originator and biosimilar… Read More »

Saving money in the European healthcare systems with biosimilars

Introduction: The use of biotechnological manufactured drugs, or biologicals, has increased massively over the past few years. Used especially in the treatment of cancer and other severe diseases, biologicals incur high… Read More »

Assessing biosimilarity and interchangeability of biosimilar products under the Biologics Price Competition and Innovation Act

Abstract: Biological (large molecule) drug products are made via living systems and are complex and variable in nature. As a result, generic forms of biological products, also termed biosimilars in… Read More »

How do regional sickness funds encourage more rational use of medicines, including the increase of generic uptake? A case study from Austria

Objective: To analyse similarities and differences between activities carried out by Austrian sickness funds to encourage more rational use of medicines, including increasing generics uptake. Methods: Semi-structured interviews with pharmacoeconomic… Read More »

Pharmacy-mediated substitution of biosimilars – a global survey benchmarking country substitution policies

Introduction/Study objectives: Between March and May 2017, Pfizer conducted an internal global survey of 82 countries examining biosimilar pharmacy-mediated substitution to understand and benchmark the global policy landscape. Methods: Pfizer… Read More »

Access to liposomal generic formulations: beyond AmBisome and Doxil/Caelyx

Abstract: The lack of clear regulatory guidance remains a key bottleneck for securing a second quality-assured source of liposomal amphotericin B (LAmB), the WHO-recommended drug for visceral leishmaniasis. The approval… Read More »

Pathway to affordable, quality-assured sources of pegylated interferon alpha for treating hepatitis C

Author byline as per print journal: Barbara Milan, Sara Gaspani Introduction: The current pipeline of promising oral hepatitis C drugs could lead to a revolution in treatment for this disease… Read More »

A review of patient perspectives on generics substitution: what are the challenges for optimal drug use

Author byline as per print journal: Helle Håkonsen, MScPharm, PhD; Else-Lydia Toverud, MScPharm, PhD Introduction: With a few exceptions, generic drug use has been promoted in western countries by allowing pharmacists to… Read More »

Overview of the patent expiry of (non-)tyrosine kinase inhibitors approved for clinical use in the EU and the US

Author byline as per print journal: Subramanian Venkatesan, MSc; Associate Professor Martine Lamfers, PhD; Professor Sieger Leenstra, MD, PhD; Professor Arnold G Vulto, PharmD, PhD, FCP Abstract: Kinase inhibitors form the… Read More »

Payers endorse generics to enhance prescribing efficiency: impact and future implications, a case history approach

Author byline as per print journal: Brian Godman1,2,3, BSc, PhD; Mohammed Abuelkhair4, PharmD; Agnes Vitry5, PharmD, PhD; Shajahan Abdu4, MD; Marion Bennie6,7, MSc; Iain Bishop7, BSc; Sahar Fahmy4, PhD; Kristina Garuoliene8,… Read More »

Differences in pharmacokinetic behaviour of branded enoxaparin and a US generic version in a non-human primate model

Author byline as per print journal: Professor Walter P Jeske, PhD; Jeanine M Walenga, PhD; Nicolas Simon, MD, PhD; Debra Hoppensteadt, PhD; Josephine Cunanan, MD; Vicki Escalante, BS; Jawed Fareed, PhD;… Read More »

Safety and toxicity of biosimilars—EU versus US regulation

Author byline as per print journal: Tobias Blank, PhD, Tilo Netzer, PhD, Wolfram Hildebrandt, MSc, MA, Angela Vogt-Eisele, PhD, Professor Marietta Kaszkin-Bettag, PhD Background: As patents for biological drugs begin… Read More »

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… Read More »

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… Read More »

Recommendations for the regulation of biosimilars and their implementation in Latin America

Author byline as per print journal: Valderilio Feijó Azevedo, MD, PhD; Eduardo Mysler, MD; Alexis Aceituno Álvarez, PharmD, PhD; Juana Hughes, MSc; Francisco Javier Flores-Murrieta, PhD, FCP; Eva Maria Ruiz de Castilla, MS, MAA, PhD… Read More »

ICH Q11: development and manufacture of drug substances–chemical and biotechnological/biological entities

Abstract:  The International Conference on Harmonisation (ICH) has endorsed a new guideline concerning the development and manufacture of chemical and biotechnological/biological drug substances. The guideline harmonises the scientific and technical… Read More »

The MEDICRIME Convention: criminalising the falsification of medicines and similar crimes

Abstract:  Trade in falsified/counterfeit medical products is a growing global criminal industry, posing a major threat to patients and healthcare systems. Falsified/Counterfeit medical products circulate via unregulated channels, especially the… Read More »

Establishment of reference standards in biosimilar studies

Abstract: When an innovative biological product goes off-patent, biopharmaceutical or biotechnological companies may file an application for regulatory approval of biosimilar products. In practice, however, important information on the innovative… Read More »

Biosimilars in oncology: current and future perspectives

Abstract: Cancer represents a significant, and growing, burden on healthcare systems. This is driven, at least in part, by escalating cancer drug budgets. Loss of patent protection on biopharmaceuticals enables… Read More »

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… Read More »

Comparison of biosimilars guidelines

Abstract: This paper provides a detailed comparison of biosimilars guidelines issued in Canada, the European Union, Japan and Korea; and by the World Health Organization (WHO). This comparison highlights the… Read More »

GnRH agonists and antagonists in prostate cancer

Author byline as per print journal: Robert Janknegt, PharmD, PhD, Niels Boone, PharmD, Frans Erdkamp, MD, PhD, Victor Zambon, MD Abstract: This manuscript describes the System of Objectified Judgement Analysis… Read More »

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