Author byline as per print journal: Rana Musa Ali Al-ali “Malkawi”, MSc; Wesal Salem Al Haqaish, BPharm; Hayel Obeidat, MD Abstract: The regulatory oversight of medicinal products in Jordan is the responsibility of the Jordan Food and Drug Administration (JFDA). In 2015, JFDA adopted biosimilar guidelines, which are similar to those used by the European […]
Author byline as per print journal: Peter J Pitts, BA; Michael S Reilly, Esq Abstract: The World Health Organization should finalize its Biological Qualifier guidance. Distinguishable naming will allow quick and accurate tracing of the manufacturer, should adverse events occur and improve patient safety by reducing confusion and mishaps. This will ensure that developing nations, including […]
Abstract: Although small molecule drugs still dominate the global pharmaceutical market in terms of numbers, biologicals are making a significant dent. However, the high cost of biologicals is putting increasing pressure on healthcare budgets, thus opening the door to biosimilars. With patents on originator biologicals expiring, biosimilars are expected to take an increasing share of […]
Author byline as per print journal: Victoire Vieillard, PharmD; Professor Alain Astier, PharmD, PhD; Muriel Paul, PharmD Objectives: This study assessed the long-term stability of the trastuzumab biosimilar CT-P6 (Herzuma®, Biogaran) in vials under various storage conditions; after reconstitution of the lyophilized powder (21 mg/mL) and after dilution for final concentrations of 0.8 mg/mL and 2.4 […]
Author byline as per print journal: Magaly Perez-Nieves1, MPH, PhD; Robyn K Pollom1, ANP; Ran Duan1, PhD; Samaneh Kabul1, PharmD; Amy M DeLozier1, MPH; Puneet Kaushik2, MPharm; Liza L Ilag1, MD Background: This analysis evaluates the patient-reported outcomes (PROs) in two randomized studies of biosimilar LY2963016 insulin glargine (LY IGlar) and Lantus® insulin glargine (IGlar), […]
Abstract: This paper highlights differences between USA and Europe when it comes to the interchangeability of biosimilars. The lack of harmonization between USA and Europe may introduce confusion for stakeholders and biosimilars makers and could be delaying access to life-saving treatments. Submitted: 5 December 2017; Revised: 7 December 2017; Accepted: 8 December 2017; Published online […]
Abstract: An extensive overview of policies related to pharmacy-mediated substitution of biosimilars across the world was carried out by Larkin et al. in 2017. The details of this are discussed in this commentary. Submitted: 17 November 2017; Revised: 28 November 2017; Accepted: 4 December 2017; Published online first: 15 December 2017 Introduction An extensive overview […]
Introduction: Launched in 2015, Zarxio™ (filgrastim-sndz) was the first biosimilar to gain US Food and Drug Administration (FDA) approval. In contrast, the first biosimilar was launched in Europe in 2006. Objective: To identify key biosimilar sales and marketing trends and their drivers, this will enable best practices to be outlined for manufacturers looking to enter […]
Abstract: The European Commission held a stakeholder event to discuss biosimilar medicinal products in May 2017. A session on building stakeholder confidence in biosimilar medicines provided an update of the latest available clinical experiences with biosimilar medicines, focusing on switching between biological medicines and interchangeability. Assistant Professor Gianluca Trifirò from the University of Messina, Italy, […]
Abstract: Comments from physician associations on the US Food and Drug Administration’s draft guidance on interchangeability of biosimilars are presented in this paper. Various issues were discussed; this paper highlights the comments on extrapolation, interchangeability, switching, labelling and naming, post-marketing and disease experts. Submitted: 2 June 2017; Revised: 13 June 2017; Accepted: 13 June 2017; […]
Author byline as per print journal: Professor Teun van Gelder, MD, PhD; Benedicte Lunddahl, DVM; Professor Barbara OM Claus, PharmD, PhD Abstract: The Medicines for Europe’s Biosimilar Medicines Group met at the 2017 European Association of Hospital Pharmacists conference in France to discuss pharmacovigilance, traceability and building trust in biosimilar medicines. Submitted: 22 May 2017; Revised: 21 […]
Abstract: In this paper, differences across the world are highlighted when it comes to the interchangeability of biosimilars. The lack of harmonization makes it difficult for biosimilars makers and could possibly delay access to life-saving treatments. Submitted: 6 April 2017; Revised: 14 April 2017; Accepted: 14 April 2017; Published online first: 28 April 2017 There […]
