Abstract: Current regulations do not require a given biosimilar to remain similar to its reference biological over time. However, two products that were initially deemed biosimilar or interchangeable could each undergo unique patterns of drift and evolution in their manufacturing processes (divergence), ultimately resulting in two products that would be no longer biosimilar. In cases […]
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, […]
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, […]
Author byline as per print journal: Adjunct Professor Valderilio Feijó Azevedo, MD, PhD, MBA; Associate Professor Brian Bressler, MD, MS, FRCPC; Madelaine A Feldman, MD, FACR; Professor Alejandro Mercedes, MD Abstract: As more biological medicines and biosimilars become increasingly available worldwide, clear product identification is critical for accurate pharmacovigilance. Submitted: 25 September 2017; Revised: 25 September […]
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 […]
Author byline as per print journal: Stuart Bloom, DM, FRCP; Keith Bodger, MBChB(Honours), MD, FRCP; Fraser Cummings, BMSc(Hons), MBChB, MRCP(UK), DPhil, FRCP; Professor Sarah Garner, BPharm, PhD; Professor Kimme Hyrich, MD, PhD, FRCPC; Clare Jacklin; Professor John G Williams, CBE, FRCP Introduction: Registries collect clinical data to evaluate specified outcomes for a population defined by a particular disease, condition […]
Author byline as per print journal: Professor Francisco José de Abajo, MD, MPH, PhD; Professor Joan Albanell, MD; Olga Delgado Sanchez, PharmD; Kevin Klein, MSc; José Vicente Moreno-Muelas, MD; Sol Ruiz, PhD; Professor Maria Jesús Sanz Ferrando, PhD; Robin Thorpe, PhD, FRCPath; Professor Francisco Zaragozá, PhD Introduction: Biosimilars can offer a lower-cost alternative to current biological therapies and could […]
Author byline as per print journal: Barbara OM Claus, PharmD, PhD; Tiene Bauters, PharmD, PhD; Annemie Somers, PharmD, PhD Abstract: In the coming decade, many patents for biological pharmaceuticals will expire. Consequently, the market for biosimilars has the potential to grow rapidly. For safety reasons, the more extensive use of a greater variety of biologicals increases […]
Abstract: The development of biological medicinal products is in rapid growth and as patents for reference products expire, new biosimilar products become available. This has a marked impact on several stakeholders; from patients and physicians to decision-makers, and on activities; from treatment of patients to the conduct of pharmacovigilance. The Danish Medicines Agency (Laegemiddelstyrelsen, DKMA) […]
Abstract: Clinical safety is important during the development of a biosimilar. This paper provides an overview of the main aspects related to the safety assessment of biosimilars. The European Medicines Agency’s ‘Guideline for similar biological medicinal products containing biotechnology-derived proteins as active substances: non-clinical and clinical issues’, which is currently under revision, forms the basis […]
Abstract: With the advent of complex therapies in the form of biologicals, emerging biosimilars and non-biological complex drugs, monitoring for treatment related benefit and the potential for adverse effects is as critical as monitoring for signs and symptoms of rheumatoid arthritis disease progression. With a focus on strengthening patient and provider education and engagement, patients […]
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 to expire, the need for scientific guidance on biosimilar drugs grows increasingly important. The European Medicines Agency provided the first guidelines to cover the approval […]
