Fast Facts: Biosimilars in Hematology and Oncology

A. Mcbride, P. Cornes

Description

Biologics have revolutionized – and are revolutionizing – the treatment of many serious disorders. The evidence acquired from more than 10 years of clinical experience, with more than 50 biosimilar drugs and more than 700 million patient-days' exposure in Europe, shows that approved biosimilars can be used as safely and effectively as originator biologics. Yet concerns persist about biosimilars – particularly in curative cancer treatment, where they are relatively recent therapeutic options. 'Fast Facts: Biosimilars in Hematology and Oncology' provides a concise overview of emerging global practice in this fast-moving area together with practical information on adding biosimilars to a formulary and switching patients. Contents: • Biologics and the need for biosimilars • Why do we need biosimilars? • How is the quality of biosimilar medicines assured? • Legal issues • Switching, interchangeability and extrapolation • Safety and pharmacovigilant • Global issues • Formulary considerations: pharmacy issues • Formulary considerations: supportive care biosimilars • Formulary considerations: therapeutic anti-cancer biosimilars • Communication and awareness

Informations

• Publié par: S. Karger AG
• Date de parution: 24 janvier 2020
• Nombre de lectures: 0
• EAN13: 9781912776221
• Langue: English
• Poids de l'ouvrage: 1 Mo

Extrait

Biosimilars in Hematology and Oncology

Paul Cornes BM BCH MA MRCP FRCR
Consultant Oncologist
Comparative Outcomes Group
Bristol, UK

Ali McBride PharmD MS BCOP FAzPA FASHP
Clinical Coordinator Hematology/Oncology
The University of Arizona Cancer Center
Tucson, Arizona, USA
Declaration of Independence
This book is as balanced and as practical as we can make it.
Ideas for improvement are always welcome: [e-mail]
Fast Facts: Biosimilars in Hematology and Oncology
First published 2020
Text 2020 Paul Cornes, Ali McBride
2020 in this edition S. Karger Publishers Limited
S. Karger Publishers Limited, Elizabeth House, Queen Street, Abingdon, Oxford OX14 3LN, UK Tel: [phone]
Book orders can be placed by telephone [phone]), email ( [e-mail] ) or via the website at: karger.com
Fast Facts is a trademark of S. Karger Publishers Limited.
All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form or by any means, electronic, mechanical, photocopying, recording or otherwise, without the express permission of the publisher.
The rights of Paul Cornes and Ali McBride to be identified as the authors of this work have been asserted in accordance with the Copyright, Designs Patents Act 1988 Sections 77 and 78.
The publisher and the authors have made every effort to ensure the accuracy of this book, but cannot accept responsibility for any errors or omissions. For all drugs, please consult the product labeling approved in your country for prescribing information.
Registered names, trademarks, etc. used in this book, even when not marked as such, are not to be considered unprotected by law.
A CIP record for this title is available from the British Library.
ISBN 978-1-912776-21-4 eISBN: 978-1-912776-23-8
Cornes P (Paul)
Fast Facts: Biosimilars in Hematology and Oncology/Paul Cornes, Ali McBride
Typesetting by Thomas Bohm, User Design, Illustration and Typesetting, UK.
Printed in the UK with Xpedient Print.
Made possible by a contribution from Sandoz. Sandoz did not have any influence on the content and all items were subject to independent peer and editorial review.
Glossary
Introduction
Biologics and the need for biosimilars
Why do we need biosimilars?
How is the quality of biosimilar medicines assured?
Legal issues
Switching, interchangeability and extrapolation
Safety and pharmacovigilance
Global issues
Formulary considerations: pharmacy issues
Formulary considerations: supportive care biosimilars
Formulary considerations: therapeutic anti-cancer biosimilars
Communication and awareness
Useful resources
Index
Glossary
Active pharmaceutical ingredient (API): The chemical substance responsible for a product s effect; WHO calls this the drug substance
Antibody-dependent cellular cytotoxicity (ADCC): Immune reaction in which the immune target becomes covered with antibodies and is killed by white blood cells that bind via the antibody
Batches and variability: A batch is a complete production run of the drug. Relevant properties may vary between batches but must be within the limits agreed with the regulator ( release specification )
Bioequivalence: Two drugs are considered bioequivalent if the rate and extent of release (i.e. the peak concentration, half-life and area under the plasma concentration-time curve) are the same. For small molecule drugs this pharmacokinetic endpoint may be sufficient to predict clinical equivalence. In contrast, due to inherent variability, biological drugs need further stepwise assessments of potency, safety and effectiveness to demonstrate equivalence
Bioidentical: Bioidentical products are the same molecule but have different brand names
Biologic/biological drug: Drug derived from a living system, usually modified bacteria, fungi or animal cells
Biosimilar: A copy of a biologic that is highly similar, but not identical, to the originator (reference) brand
Critical quality attribute (CQA): A chemical, physical, biological or microbiological attribute that can predict the quality, safety and efficacy (QSE) of a biological drug. Biosimilar manufacturers aim to develop a version of the drug that matches as closely as possible the CQAs of the original reference medicine. Not all variation between drugs will risk changes to a drug s QSE. Biosimilars with the highest level of match of CQA are described by the US regulator as being highly similar with fingerprint-like similarity
Dosage form: The final form of the completed pharmaceutical product, e.g. tablet, capsule, suspension, injection. Also called dose form or dosing unit
Drift: An unintended, unexplained or unexpected trend of measured process parameter(s) and/or resulting product attribute(s) away from its intended target value in a time-ordered analysis over the lifetime of a process or product
EPAR: The European Public Assessment Report contains scientific and technical information for a product relating to the development of the medicine - including efficacy, pharmacokinetics, safety and immunogenicity. Biosimilars and originators have different EPARs; in contrast to European Summaries of Product Characteristics (SPC) and package inserts where the texts are usually the same
Excipient: Any component of a finished medicine other than the claimed active therapeutic ingredient or ingredients
Extrapolation: Approval of an indication for a biosimilar for which it has not been clinically tested, based on the indications of the reference/originator product
Finished product: A product that has undergone all stages of production, including packaging in its final container and labeling
Formulation: The composition of a final dosage form, including the characteristics of its raw materials and the operations required to process it
Immunogenicity: The propensity of a therapeutic protein product to generate immune responses to itself and to related proteins or to induce immunologically related adverse clinical events
INN: International non-proprietary name - the name determined by WHO which indicates the active drug ingredient; sometimes referred to as the generic name
Intended-copy biologic: Copies of biologics manufactured in countries with less stringent regulatory pathways than the EU and USA; these are not biosimilars and may differ in structure from the reference biologic such that efficacy and safety are different
Interchangeable: A scientific and medical term that means changing one brand of a medicine for another that is expected to achieve the same clinical effect in a given clinical setting and in any patient on the initiative or with the agreement of the prescriber (note that this term has different legal interpretations in the USA and Europe; see chapter 5 )
Microheterogeneity: Minor variability in the molecular profile of a biological agent that results from the production of complex molecules using living cells
Pharmacovigilance: The practice of monitoring the effects of medical drugs after they have been licensed for use, especially in order to detect previously unreported adverse effects
Proposed biosimilar: A biosimilar that is in development but has yet to be reviewed or approved by regulatory authorities
Reference medicine/originator product: An already approved biologic selected by the manufacturer of a biosimilar as the comparator for biosimilarity analyses. The reference medicine will have been approved based on full preclinical data and clinical studies in each of the authorized indications; the aim of the final clinical pivotal trial is to show that the new medicine offers a clinical difference over existing products. In contrast, the biosimilar drug application is based on the demonstration of similarity to the reference/originator product
Release specification: Quality specification of a finished pharmaceutical product at manufacture
Risk minimization plan (RMP): A risk management system is a set of pharmacovigilance activities and interventions designed to identify, characterize, prevent or minimize risks relating to medicinal products including the assessment of the effectiveness of those interventions
Substitution: Dispensing by a pharmacist of the same drug (with the same INN) but of a different brand without the requirement to consult with the prescriber. Automatic substitution is accepted and promoted in many countries for small molecule generic medicines. Automatic substitution of biosimilars is not permitted in most nations of the EU or USA
Switching: Changing a patient from one treatment (biologic/biosimilar) to another; this is a clinical decision (in contrast to substitution, which is at the pharmacy level)
A note from the authors
We thank you for giving up your precious time to think about biosimilars and their use in hematology and oncology. We hope Fast Facts: Biosimilars in Hematology and Oncology enables you to take a greater part in debates and discussions at formulary committees and in clinics and pharmacies, professional societies, payer organizations and the companies that develop these medicines.
We are very grateful for the significant time given up by many colleagues in hospitals, universities, regulatory agencies and pharmaceutical companies who have reviewed this book. Great care has been taken to avoid errors or significant omissions, but no individuals are perfect. Where we have succeeded, we want to share credit; where we have failed, please offer feedback to us to improve the next edition at fastfacts@karger