Search results for Original Research

Local policies on biosimilars: are they designed to optimize use of liberated resources?

Author byline as per print journal: Arianna Bertolani, PhD; Claudio Jommi, MS Study Objectives: Different policies have been implemented to enhance uptake of biosimilars. Regarding policies focussing on the demand-side, the literature has mainly concentrated on interchangeability and substitutability recommendations, issued by national or regional policymakers. Information on actions taken by healthcare organisations (HCOs) regarding […]

Read more →

Systematic analysis of injection-site pain and reactions caused by subcutaneous administration of the adalimumab biosimilar FKB327 versus the adalimumab reference product via different delivery methods

Author byline as per print journal: Rieke Alten1, MD, PhD; Herbert Kellner2, MD; Malcolm Boyce3, MD; Takuma Yonemura4, MD; Takahiro Ito5, MSc; Mark C Genovese6, MD Introduction/Study objectives: FKB327 is a biosimilar of the adalimumab reference product. Studies in healthy subjects and patients with rheumatoid arthritis demonstrated biosimilarity between FKB327 and the reference product in […]

Read more →

European prescribers’ attitudes and beliefs on biologicals prescribing and automatic substitution

Introduction: The European Union (EU) and the European Medicines Agency (EMA) have led the development of a regulatory framework for biosimilars since 2004. By end of December 2019, 64 biosimilars of 15 originator biological medicines have a marketing authorization in Europe. Now, for the second time, the Alliance for Safe Biologic Medicines (ASBM) asked European […]

Read more →

Qualitative survey-based evaluation of operability and convenience for the etanercept biosimilar YLB113 in a unique injection pen in patients with rheumatoid arthritis

Author byline as per print journal: Toshihiko Hibino1, MD; Tomohiko Yoshida2, MD, PhD; Akira Sagawa3, MD, PhD; Ikuko Masuda4, MD, PhD; Takaaki Fukuda5, MD Introduction/Study objective: Needle fear is common among patients with rheumatoid arthritis (RA) who require subcutaneous (SC) injections. The convenience, usability and safety of the etanercept biosimilar YLB113 in an injection pen […]

Read more →

Pharmaceutical pricing policy in Saudi Arabia: findings and implications

Introduction: Many countries have introduced policies and strategies to limit pharmaceutical expenditures. These include pharmaceutical pricing policies and related strategies to control medicine prices and to ensure appropriate and stable prices. The aim of this study was to provide an overview of the current pharmaceutical pricing policy for medicines in Saudi Arabia and to provide […]

Read more →

Implementing a treatment registry for a biosimilar: continuous safety surveillance of the biosimilar Bevax® (bevacizumab) in Argentina

Introduction and study objectives: Benefit-risk evaluations are essential throughout the life cycle of a drug to guarantee therapeutic efficacy for the authorized indications without an unacceptable incidence of adverse effects. To achieve this, a registry, assessment of adverse drug reactions (ADRs) and other pharmacovigilance (PhV) procedures are mandatory. Due to the inherent variability of bioproduction, […]

Read more →

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 […]

Read more →

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 […]

Read more →

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 […]

Read more →

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), […]

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 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 […]

Read more →

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 […]

Read more →