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Expert Opinion on Biological Therapy Volume 13, 2013 - Issue 7
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Reviews

Pharmacovigilance and biosimilars: considerations, needs and challenges

Nicole CasadevallProfessor, Hôpital Saint Antoine, Paris, France
, MD,
I Ralph EdwardsSenior Advisor, Uppsala Monitoring Centre, Uppsala, Sweden
, MD FRCP,
Thomas FelixDirector, Regulatory Policy, Amgen Inc., Thousand Oaks, CA, USA
, MD,
Peter R GrazeMedical Oncologist, DeCesaris Cancer Institute, Annapolis, MD, USA
, MD FACP,
Jason B LittenClinical Research Medical Director, Amgen Inc., One Amgen Center Drive, 38-B-A, Thousand Oaks, CA 91320, USA+1 805 447 4543; +1 805 376 8522; [email protected]
, MD,
Bruce E StroberAssociate Professor and Director of Clinical Trials, University of Connecticut School of Medicine, Department of Dermatology, Farmington, CT, USA
, MD PhD &
David G WarnockProfessor, University of Alabama at Birmingham, Birmingham, AL, USA
, MD show all
Pages 1039-1047 | Published online: 26 Mar 2013

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Sadia Shakeel, Mohamed Azmi Hassali, Hina Rehman, Anees ur Rehman & Jaya Muneswarao. (2020) Knowledge, Attitude, and Practice Towards Biosimilars and Interchangeable Products: A Prescriptive Insight by the Pharmacists. International Journal of General Medicine 13, pages 1075-1082.
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Thomas Felix, John B. Jordan, Catherine Akers, Bina Patel & Daniela Drago. (2019) Current state of biologic pharmacovigilance in the European Union: improvements are needed. Expert Opinion on Drug Safety 18:3, pages 231-240.
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Maria da Conceição Constantino Portela, Carlos Sinogas, Fernando Albuquerque de Almeida, Ricardo Baptista-Leite & Alexandre Castro-Caldas. (2017) Biologicals and biosimilars: safety issues in Europe. Expert Opinion on Biological Therapy 17:7, pages 871-877.
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Paul Declerck, Håkan Mellstedt & Silvio Danese. (2015) Biosimilars – terms of use. Current Medical Research and Opinion 31:12, pages 2325-2330.
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Judith C Macdonald, Helen Hartman & Ira A Jacobs. (2015) Regulatory considerations in oncologic biosimilar drug development. mAbs 7:4, pages 653-661.
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Mark A Socinski, Giuseppe Curigliano, Ira Jacobs, Barry Gumbiner, Judith MacDonald & Dolca Thomas. (2015) Clinical considerations for the development of biosimilars in oncology. mAbs 7:2, pages 286-293.
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Mary Lynn Davis-Ajami, Jun Wu, Katherine Downton, Emilie Ludeman & Virginia Noxon. (2014) Epoetin zeta in the management of anemia associated with chronic kidney disease, differential pharmacology and clinical utility. Biologics: Targets and Therapy 8, pages 155-167.
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Martin K Kuhlmann & Andrea Schmidt. (2014) Production and manufacturing of biosimilar insulins: implications for patients, physicians, and health care systems. Biosimilars 4, pages 45-58.
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Muna Oqal, Bushra Hijazi, Abdelrahim Alqudah, Ahmad Al-Smadi, Basima A Almomani, Roaa Alnajjar, Majd Abu Ghunaim, Mohammad Irshaid & Aroob Husam. (2022) Awareness and Knowledge of Pharmacists toward Biosimilar Medicines: A Survey in Jordan. International Journal of Clinical Practice 2022, pages 1-10.
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Luis Correia Pinheiro, Thijs J. Giezen, Elena Wolff‐Holz, Martina Weise, Andrea Laslop & Ana Hidalgo‐Simon. (2021) Identifiability of Biologicals: An Analysis Using EudraVigilance, the European Union's Database of Reports of Suspected Adverse Drug Reactions. Clinical Pharmacology & Therapeutics 110:5, pages 1311-1317.
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Aayushi S. Ditani, Pragyan Paramita Mallick, Neelima Anup, Vishakha Tambe, Suryanarayana Polaka, Pinaki Sengupta, Kuldeep Rajpoot & Rakesh K. Tekade. (2021) Biosimilars accessible in the market for the treatment of cancer. Journal of Controlled Release 336, pages 112-129.
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Charles L. Bennett, Sumimasa Nagai, Andrew C. Bennett, Shamia Hoque, Chadi Nabhan, Martin W. Schoen, William J. Hrushesky, Stefano Luminari, Paul Ray, Paul R. Yarnold, Bart Witherspoon, Josh Riente, Laura Bobolts, John Brusk, Rebecca Tombleson, Kevin Knopf, Marc Fishman, Y. Tony Yang, Kenneth R. Carson, Benjamin Djulbegovic, John Restaino, James O. Armitage & Oliver A. Sartor. (2021) The First 2 Years of Biosimilar Epoetin for Cancer and Chemotherapy-Induced Anemia in the U.S.: A Review from the Southern Network on Adverse Reactions. The Oncologist 26:8, pages e1418-e1426.
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Catherine A. Panozzo, Kevin Huang & Christine Y. Lu. 2020. Biologics, Biosimilars, and Biobetters. Biologics, Biosimilars, and Biobetters 177 194 .
Khalid K. Al-Kinani, Mazin J. Ibrahim, Ruaa F. Al-Zubaidi, Manal M. Younus, Samir H. Ramadhan, Hussein J. Kadhim & Rodeina Challand. (2020) Iraqi regulatory authority current system and experience with biosimilars. Regulatory Toxicology and Pharmacology 117, pages 104768.
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Brian G. Feagan, Mona Marabani, Jashin J. Wu, Freddy Faccin, Claire Spronk & Gilberto Castañeda-Hernández. (2020) The Challenges of Switching Therapies in an Evolving Multiple Biosimilars Landscape: A Narrative Review of Current Evidence. Advances in Therapy 37:11, pages 4491-4518.
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Sean AinsworthSean Ainsworth. 2020. Neonatal Formulary. Neonatal Formulary.
Ashish Sharma, Nilesh Kumar, Baruch D Kuppermann, Francesco Bandello & Anat Loewenstein. (2020) Understanding biosimilars and its regulatory aspects across the globe: an ophthalmology perspective. British Journal of Ophthalmology 104:1, pages 2-7.
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Carlos Vinicius Caballero-Uribe, Valderilio Feijó Azevedo, Enrique Roberto Soriano, Carlos Pineda, Claudio Galarza-Maldonado, Igor Age Kos & Osvaldo Castañeda Jimenez. (2020) Report on the Second PANLAR Review Course in Rheumatology. JCR: Journal of Clinical Rheumatology 26:1, pages 33-36.
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Rani J. Qasem, Anas S. Aldawsari, Faisal E. Almutairi & Abdullah S. Alsadoon. (2019) Identification of recombinant human insulin and biosynthetic insulin analogues by multiplexed targeted unlabeled mass spectrometry of proteotypic tryptic peptides. Journal of Pharmaceutical and Biomedical Analysis 172, pages 357-363.
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Efraín Esteban, Rosa-Helena Bustos, Julio-César García & Edwin Jáuregui. (2019) Biosimilars: An Approach to some Current Worldwide Regulation Frameworks. Current Clinical Pharmacology 14:1, pages 16-40.
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Jazel Sugay. (2018) Clinical Trials: Nursing Roles During the Approval Process and Pharmacovigilance of Biosimilars. Clinical Journal of Oncology Nursing 22:5, pages 27-32.
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Begoña Calvo, Javier Martinez-Gorostiaga & Enrique Echevarria. (2018) The surge in biosimilars: considerations for effective pharmacovigilance and EU regulation. Therapeutic Advances in Drug Safety 9:10, pages 601-608.
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J. Goncalves, F. Magro, S. Danese, P. L. Lakatos & S. Ben-Horin. (2018) Editorial: antigenic response to CT-P13 and infliximab originator in IBD shows similar epitope recognition-evidence from basic science supports safe switching to biosimilars. Authors’ reply. Alimentary Pharmacology & Therapeutics 48:5, pages 575-576.
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Oscar O Agoro, Sarah W Kibira, Jenny V Freeman & Hamish S F Fraser. (2018) Barriers to the success of an electronic pharmacovigilance reporting system in Kenya: an evaluation three years post implementation. Journal of the American Medical Informatics Association 25:6, pages 627-634.
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Thomas Felix, Binakumari Patel, Brian D. Bradbury & Gustavo Grampp. 2018. Biosimilars. Biosimilars 631 652 .
A.D. Cohen, J.J. WuL. Puig, S. Chimenti, R. Vender, M. Rajagopalan, R. Romiti, C. de la Cruz, L. Skov, C. Zachariae, H.S. Young, P. Foley, J.M. van der Walt, L. Naldi, E.P. Prens & A. Blauvelt. (2017) Biosimilars for psoriasis: worldwide overview of regulatory guidelines, uptake and implications for dermatology clinical practice. British Journal of Dermatology 177:6, pages 1495-1502.
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Carolina Negrei & Daniel Boda. 2017. An Interdisciplinary Approach to Psoriasis. An Interdisciplinary Approach to Psoriasis.
John Romley & Tiffany Shih. (2016) Product safety spillovers and market viability for biologic drugs. International Journal of Health Economics and Management 17:2, pages 135-158.
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Vida Vizgirda & Ira Jacobs. (2017) Biosimilars: Considerations for Oncology Nurses
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Jürgen Braun & Alex Kudrin. (2016) Switching to biosimilar infliximab (CT-P13): Evidence of clinical safety, effectiveness and impact on public health. Biologicals 44:4, pages 257-266.
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Eduardo Mysler, Carlos Pineda, Takahiko Horiuchi, Ena Singh, Ehab Mahgoub, Javier Coindreau & Ira Jacobs. (2016) Clinical and regulatory perspectives on biosimilar therapies and intended copies of biologics in rheumatology. Rheumatology International 36:5, pages 613-625.
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Camila dos Reis, Ricardo Teixo, Fernando Mendes & Rui Santos Cruz. (2016) Biosimilar medicines – Review. International Journal of Risk & Safety in Medicine 28:1, pages 45-60.
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Theresa Yuraszeck & Megan Gibbs. 2010. Pharmaceutical Sciences Encyclopedia. Pharmaceutical Sciences Encyclopedia 1 15 .
Sarfaraz Niazi. 2015. Biosimilars and Interchangeable Biologics. Biosimilars and Interchangeable Biologics 1 22 .
Gustavo Grampp & Sundar Ramanan. (2015) The Diversity of Biosimilar Design and Development: Implications for Policies and Stakeholders. BioDrugs 29:6, pages 365-372.
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Gustavo Grampp & Thomas Felix. (2015) Pharmacovigilance Considerations for Biosimilars in the USA. BioDrugs 29:5, pages 309-321.
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Valderílio Feijó Azevedo, Eduardo de Souza Meirelles, Jussara de Almeida Lima Kochen, Ana Cristina Medeiros, Sender J. Miszputen, Fábio Vieira Teixeira, Adérson Osmar Mourão Cintra Damião, Paulo Gustavo Kotze, Ricardo Romiti, Marcelo Arnone, Renata Ferreira Magalhães, Cláudia Pires Amaral Maia & André Vicente E. de Carvalho. (2015) Recommendations on the use of biosimilars by the Brazilian Society of Rheumatology, Brazilian Society of Dermatology, Brazilian Federation of Gastroenterology and Brazilian Study Group on Inflammatory Bowel Disease—Focus on clinical evaluation of monoclonal antibodies and fusion proteins used in the treatment of autoimmune diseases. Autoimmunity Reviews 14:9, pages 769-773.
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Carlos Pineda, Carlo V. Caballero-Uribe, Marcia Gonclaves de Oliveira, Pedro Saul Lipszyc, Jose Julian Lopez, Marcelo Mario Mataos Moreira & Valderilio Feijo Azevedo. (2015) Recommendations on how to ensure the safety and effectiveness of biosimilars in Latin America: a point of view. Clinical Rheumatology 34:4, pages 635-640.
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Jingdong Chao, Martha Skup, Emily Alexander, Namita Tundia, Dendy Macaulay, Eric Wu & Parvez Mulani. (2015) Nomenclature and Traceability Debate for Biosimilars: Small-Molecule Surrogates Lend Support for Distinguishable Nonproprietary Names. Advances in Therapy 32:3, pages 270-283.
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Tejas Sheth, C. S. Pitchumoni & Kiron M. Das. (2015) Management of Musculoskeletal Manifestations in Inflammatory Bowel Disease. Gastroenterology Research and Practice 2015, pages 1-11.
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Niesha Griffith, Ali McBride, James G. Stevenson & Larry Green. (2014) Formulary Selection Criteria for Biosimilars: Considerations for US Health-System Pharmacists. Hospital Pharmacy 49:9, pages 813-825.
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Nicole Casadevall, Thomas Felix, Bruce E. Strober & David G. Warnock. (2014) Similar Names for Similar Biologics. BioDrugs 28:5, pages 439-444.
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Sundar Ramanan & Gustavo Grampp. (2014) Drift, Evolution, and Divergence in Biologics and Biosimilars Manufacturing. BioDrugs 28:4, pages 363-372.
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Marc Alexander Radtke & Matthias Augustin. (2014) Biosimilars in psoriasis: What can we expect?. JDDG: Journal der Deutschen Dermatologischen Gesellschaft 12:4, pages 306-312.
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Jame Abraham. (2014) Introduction and Commentary: Paving the Way for Biosimilars in Oncology, Part 3. Seminars in Oncology 41, pages S1-S2.
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Ali McBride. (2017) Evolving Biosimilars Marketplace. Hospital Pharmacy 49:1_suppl, pages 1-5.
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Lynne A. Bui & Carrie Taylor. (2014) Developing Clinical Trials for Biosimilars. Seminars in Oncology 41, pages S15-S25.
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Edwin Choy & Ira Allen Jacobs. (2014) Biosimilar Safety Considerations in Clinical Practice. Seminars in Oncology 41, pages S3-S14.
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Begoña Calvo. (2013) Author’s Reply to Borg et al. Comment on: “EU’s New Pharmacovigilance Legislation: Considerations for Biosimilars”. Drug Safety 37:2, pages 125-126.
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Begoña Calvo & Leyre Zuñiga. (2013) EU’s New Pharmacovigilance Legislation: Considerations for Biosimilars. Drug Safety 37:1, pages 9-18.
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Jame Abraham. (2013) Developing Oncology Biosimilars: An Essential Approach for the Future. Seminars in Oncology 40, pages S5-S24.
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Jame Abraham. (2013) Introduction and Commentary: Paving the Way for Biosimilars in Oncology. Seminars in Oncology 40, pages S1-S4.
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Steven D. Lucio, James G. Stevenson & James M. Hoffman. (2013) Biosimilars: Implications for health-system pharmacists. American Journal of Health-System Pharmacy 70:22, pages 2004-2017.
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John Romley & Tiffany Shih. (2015) Product Safety Spillovers and Market Viability for Biologic Drugs. SSRN Electronic Journal.
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