Abstract: Biosimilar products confront novel market authorization and post-marketing use hurdles. Existing evidence is insufficient to fully address physician and payer acceptability thresholds. Submitted: 4 March 2015; Revised: 5 March 2015; Accepted: 9 March 2015; Published online first: 20 March 2015 In this issue of GaBI Journal, Sandorff et al. [1] investigate payer and physician […]
Abstract: Biosimilars are copies of original biological medicines. Biosimilarity is a new concept in drug development. Physicians prescribing biologicals need more neutral information on the quality, safety and efficacy of biosimilars. Submitted: 27 November 2014; Revised: 15 December 2014; Accepted: 18 December 2014; Published online first: 19 December 2014 Introduction The European Union (EU) was […]
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 2014; Accepted: 12 November 2014; Published online first: 25 November 2014 Concerning the biosimilar landscape, the European Medicines Agency (EMA) was among the first institutions […]
Author byline as per print journal: Gianluca Trifirò, MD, PhD; Meteb Al-Foheidi, MD, FRCPC; Ali M Alhomaidan, PhD; Ahmed H Aljedai, PharmD, MBA, BCPS, FCCP, FAST; Musaed Abdullah Alkholief, PhD; Mohammad A Alsenaidy, MSc, PhD; Aws Alshamsan, BPharm, RPh, PhD; Tore Kristian Kvien, MD, PhD Introduction: A meeting was organized by the Generics and Biosimilars […]
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 as part of the Affordable Care Act. Biosimilars are anticipated to increase treatment options and lower the growth in spending on biologicals. How the commercial […]
Abstract: The arrival of biosimilars has led to considerable debate on how they can be used in clinical practice. A particular concern is related to the question of whether a biosimilar can be safely interchanged with the originator product or other biosimilars. Here we will discuss challenges to the regulatory approach for establishing interchangeability, in […]
Author byline as per print journal: Professor Jacques Rottembourg, MD; Corinne Emery, MSc; Alessandra Moglia, PhD Study objective: To describe and compare the haematological parameters and the anaemia medication use in haemodialysis patients who were switched from the originator iron sucrose (IS) to an iron sucrose similar (ISS). Methods: A retrospective observational single-centre study describing chronic […]
Abstract: As the patents of a growing number of biological medicines have already expired or are due to expire, it has led to an increased interest from both the biopharmaceutical industry and the regulatory agencies in the development and approval of biosimilars. With the high urgency, European Medicines Agency released the first general guideline on […]
Author byline as per print journal: Professor Shein-Chung Chow, PhD, Christine Ju, MSc 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 the EU or follow-on biologics by the US Food and Drug Administration, can […]
Abstract: Marketed medicines that have passed bioequivalence testing should in general be substitutable. However, for a variety of reasons, caution may be warranted, particularly with regard to narrow therapeutic index drugs and the indiscriminate use of biosimilars. The Royal Dutch Pharmacists Association (KNMP) has published professional guidelines for community pharmacies concerning generic substitution. The guidelines […]
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 requirements for registration apply. Whereas pharmaceutical quality evaluation requires a full dossier and a detailed comparative analysis to the reference drug, non-clinical and clinical requirements […]
