Search results for Original Research

In vitro analytical and antibiotic comparison of generic moxifloxacin against E. coli and S. aureus bacteria strains

Author byline as per print journal: Auxiliary Professor Antistio Alviz-Amador1, MSc, Pharmaceutical Chemist; Jairo E Mercado Camargo2, MSc; Marlene Duran-Lengua3, MSc, PhD, Bacteriologist Introduction: Moxifloxacin is a quinolone antibiotic often used to treat infections caused by Gram-positive bacteria that have developed resistance in Colombia in recent years. Objective: To evaluate the concentration of active ingredient and the antibacterial […]

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Analysis of Drug Master Files registered in Japan: aiming for a stable supply of active pharmaceutical ingredients

Introduction/Study objectives: A stable supply of active pharmaceutical ingredients (APIs) is indispensable for a stable supply of finished pharmaceutical products (FPPs). API manufacturers generally register API information as a Drug Master File (DMF) directly to the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. Because DMFs require appropriate management by their registrants, it is important […]

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Extended stability of a biosimilar of trastuzumab (CT-P6) after reconstitution in vials, dilution in polyolefin bags and storage at various temperatures

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 […]

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Patient-reported outcome measures in phase III trials of LY2963016 insulin glargine and reference insulin glargine products: ELEMENT 1 and ELEMENT 2

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), […]

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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 regulatory and corporate affairs colleagues completed a survey: Are pharmacists in your country able to substitute a biological with a biosimilar without the physician being […]

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A survey of Australian prescribers’ views on the naming and substitution of biologicals

Author byline as per print journal: Stephen P Murby, FRSA; Michael S Reilly, Esq Introduction: As the number of biosimilar approvals in Australia increases, it is important to build on the existing regulatory framework to continue to bring high quality, safe and efficacious biosimilars to the widest number of patients most cost-effectively. As new policies regarding […]

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Do pricing and usage-enhancing policies differ between biosimilars and generics? Findings from an international survey

Introduction/Study objective: This paper aims to survey the policies implemented by European countries for pricing and promoting the use of biosimilar medicines and to explore similarities and differences with policies for generic medicines. Methods: A literature review was supplemented by primary data collection with policymakers. Members of the Pharmaceutical Pricing and Reimbursement Information (PPRI) network, […]

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What pricing and reimbursement policies to use for off-patent biologicals in Europe? – results from the second EBE biological medicines policy survey

Author byline as per print journal: Jean-Baptiste Reiland, MSc; Barbara Freischem; Alexander Roediger, MA Introduction/Study objective Biosimilar policies with a focus on uptake have received a lot of attention at national and regional level in the last few years. It is now 10 years since the first biosimilar was approved in the European Union (EU), but […]

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Naming and labelling of biologicals – a survey of US physicians’ perspectives

Introduction: The US Food and Drug Association (FDA) released its requirements for the non-proprietary naming of biological products in January 2017. Before the FDA’s release, the Alliance for Safe Biologic Medicines (ASBM) asked physicians for their views on the labelling and naming of biosimilar medicines. Study objectives: To determine the opinions of physicians who prescribe […]

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Naming and labelling of biologicals – the perspective of hospital and retail pharmacists

Author byline as per print journal: Professor Philip J Schneider, MS, FASHP; Michael S Reilly, Esq Introduction: To date, the US Food and Drug Administration (FDA) has offered only draft guidance on the naming of biosimilar medicines. The Alliance for Safe Biologic Medicines (ASBM) has asked pharmacists for their views on the labelling and naming of […]

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Assessment of active pharmaceutical ingredients in drug registration procedures in Pakistan: implications for the future

Author byline as per print journal: Babar Khan, BPharm, MPH, PhD; Brian Godman, BSc, PhD; Ayesha Babar, BPharm, MPhil; Shahzad Hussain, BPharm, MPhil; Sidra Mahmood, PharmD, MSc; Tahir Aqeel, BPharm, MPhil Introduction: There are concerns over the quality of generic medicines in Pakistan. This is due to perceived non-compliance with good manufacturing practice (GMP), whereby the […]

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Views of physicians and patients with chronic conditions on generic medicines in Greece after the introduction of measures to promote their consumption: findings from a qualitative study

Author byline as per print journal: Eleftheria Karampli, MSc; Estathia Triga, MSc; Vasiliki Tsiantou, MSc; Kostas Athanasakis, PhD; John Kyriopoulos, PhD Introduction/Study objectives: Generic medicines uptake is widely acknowledged as a key pharmaceutical policy measure towards cost containment and rational resource allocation. In Greece, due to the persistently low penetration of generics in the pharmaceutical […]

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