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Future Perspective

Biosimilars: current status and future directions

Pages 1011-1018 | Published online: 12 Apr 2010

Keep up to date with the latest research on this topic with citation updates for this article.

Read on this site (4)

Benjamín Reyes-Beltrán & Gabriela Delgado. (2017) Anti-drug antibodies in Colombian patients with rheumatoid arthritis treated with Enbrel vs Etanar – Preliminary report. Journal of Immunotoxicology 14:1, pages 103-108.
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Zayrho Desanvicente-Celis, Julian Caro-Moreno, Mateo Enciso-Zuluaga & Juan-Manuel Anaya. (2013) Similar biotherapeutic products in Latin America. Regulation and opportunities for patients with autoimmune diseases. Biosimilars 3, pages 1-17.
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Lutz Heinemann. (2012) Biosimilar insulins. Expert Opinion on Biological Therapy 12:8, pages 1009-1016.
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Trent P. Munro, Stephen M. Mahler, Edwin P. Huang, David Y. Chin & Peter P. Gray. (2011) Bridging the gap. mAbs 3:5, pages 440-452.
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Articles from other publishers (51)

Faraat Ali, Kamna Sharma & Asad Ali. (2022) Pegfilgrastim-Apgf (Nyvepria): Biosimilar USFDA Approval for the Treatment of Chemotherapy-induced Febrile Neutropenia and Current Updates on Clinical Trials. Current Drug Targets 23:9, pages 924-932.
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Conor M.W. Douglas, Dimitra Panagiotoglou, Nick Dragojlovic & Larry Lynd. (2021) Methodology for constructing scenarios for health policy research: The case of coverage decision-making for drugs for rare diseases in Canada. Technological Forecasting and Social Change 171, pages 120960.
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Olga Barszczewska & Anna Piechota. (2021) The Impact of Introducing Successive Biosimilars on Changes in Prices of Adalimumab, Infliximab, and Trastuzumab—Polish Experiences. International Journal of Environmental Research and Public Health 18:13, pages 6952.
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Garima Thakur, Vishwanath Hebbi, Subhash Parida & Anurag S. Rathore. (2020) Automation of Dead End Filtration: An Enabler for Continuous Processing of Biotherapeutics. Frontiers in Bioengineering and Biotechnology 8.
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Shruti Rastogi, Shatrunajay Shukla, Arvind Kumar Sharma, Maryam Sarwat, Pranay Srivastava, Tridiv Katiyar, Vivekanandan Kalaiselvan & Gyanendra Nath Singh. (2020) Towards a comprehensive safety understanding of granulocyte-colony stimulating factor biosimilars in treating chemotherapy associated febrile neutropenia: Trends from decades of data. Toxicology and Applied Pharmacology 395, pages 114976.
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M. Aljurf, D. Weisdorf, S.K. Hashmi, A. Nassar, E. Gluckman, M. Mohty, D. Rizzo, M. Pasquini, M. Hamadani, W. Saber, P. Hari, M. Kharfan-Dabaja, N. Majhail, U. Gerges, Amir Ali Hamidieh, F. Hussain, A. Elhaddad, H.K. Mahmoud, A. Tbakhi, T.B. Othman, R.M. Hamladji, M.A. Bekadja, P. Ahmed, A. Bazarbachi, S. Adil, S. Alkindi, S. Ladeb, D. Dennison, M. Patel, P. Lu, A.E. Quessar, S. Okamoto, Y. Atsuta, A. Alhejazi, M. Ayas, S.O. Ahmed, N. Novitzky, A. Srivastava, A. Seber, H. Elsolh, A. Ghavamzadeh, D. Confer, Y. Kodera, H. Greinix, J. Szer, M. Horowitz & D. Niederwieser. (2020) Worldwide Network for Blood and Marrow Transplantation (WBMT) recommendations for establishing a hematopoietic stem cell transplantation program in countries with limited resources (Part II): Clinical, technical and socio-economic considerations. Hematology/Oncology and Stem Cell Therapy 13:1, pages 7-16.
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Ramesh Jois, Sukumar Mukherjee, S Rajeswari, PD Rath, Vishal Goyal & Disha Gupta. (2020) Similar biologics in India: A story of access or potential for compromise?. Indian Journal of Medical Research 152:5, pages 456.
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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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Mahmoud Aljurf, Daniel Weisdorf, Shahrukh Hashmi, Amr Nassar, Eliane Gluckman, Mohamad Mohty, Doug Rizzo, Marcelo Pasquini, Mehdi Hamadani, Wael Saber, Parameswaran Hari, Mohamed Kharfan-Dabaja, Navneet Majhail, Usama Gerges, Amir Ali Hamidieh, Fazal Hussain, Alaa Elhaddad, Hossam K Mahmoud, Abdelghani Tbakhi, Tarek Ben Othman, Rose-Marie Hamladji, Mohamed Amine Bekadja, Parvez Ahmed, Ali Bazarbachi, Salman Adil, Salman Alkindi, Saleh Ladeb, David Dennison, Moosa Patel, Peihua Lu, Asma El Quessar, Shinichiro Okamoto, Yoshiko Atsuta, Ayman Alhejazi, Mouhab F Ayas, Syed O Ahmed, Nickolas Novitzky, Alok Srivastava, Adriana Seber, Hassan El Solh, Ardeshir Ghavamzadeh, Dennis Confer, Yoshihisa Kodera, Greinix Hildegard, Jeff Szer, Mary M Horowitz & Dietger Niederwieser. (2019) Worldwide Network for Blood and Marrow Transplantation Recommendations for Establishing a Hematopoietic Stem Cell Transplantation Program in Countries with Limited Resources, Part II: Clinical, Technical, and Socioeconomic Considerations. Biology of Blood and Marrow Transplantation 25:12, pages 2330-2337.
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Janine Griesser, Gergely Hetényi, Christoph Federer, Christian Steinbring, Helmut Ellemunter, Katharina Niedermayr & Andreas Bernkop-Schnürch. (2019) Highly mucus permeating and zeta potential changing self-emulsifying drug delivery systems: A potent gene delivery model for causal treatment of cystic fibrosis. International Journal of Pharmaceutics 557, pages 124-134.
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John Zalcberg. (2018) Biosimilars are coming: ready or not. Internal Medicine Journal 48:9, pages 1027-1034.
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Corrado Blandizzi, Mauro Galeazzi & Guido Valesini. (2018) Transitioning from first- to second-generation biosimilars: An appraisal of regulatory and post-marketing challenges. Pharmacological Research 128, pages 306-314.
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Amr Nassar, Alok Srivastava, Shahrukh K. Hashmi & Mahmoud Aljurf. 2018. Establishing a Hematopoietic Stem Cell Transplantation Unit. Establishing a Hematopoietic Stem Cell Transplantation Unit 257 270 .
Eline van Overbeeke, Birgit De Beleyr, Jan de Hoon, Rene Westhovens & Isabelle Huys. (2017) Perception of Originator Biologics and Biosimilars: A Survey Among Belgian Rheumatoid Arthritis Patients and Rheumatologists. BioDrugs 31:5, pages 447-459.
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Anil K. Sharma, Raj K. Keservani & Rajesh K. Kesharwani. 2017. Novel Approaches for Drug Delivery. Novel Approaches for Drug Delivery 171 188 .
H.A. Daniel Lagassé, Aikaterini Alexaki, Vijaya L. Simhadri, Nobuko H. Katagiri, Wojciech Jankowski, Zuben E. Sauna & Chava Kimchi-Sarfaty. (2017) Recent advances in (therapeutic protein) drug development. F1000Research 6, pages 113.
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An Zhang, Valerie Liu Tsang, Lam R. Markely, Lutfiye Kurt, Yao-Ming Huang, Shashi Prajapati & Rashmi Kshirsagar. (2016) Identifying the differences in mechanisms of mycophenolic acid controlling fucose content of glycoproteins expressed in different CHO cell lines. Biotechnology and Bioengineering 113:11, pages 2367-2376.
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Matthew J Renwick, Kate Smolina, Emilie J Gladstone, Deirdre Weymann & Steven G Morgan. (2016) Postmarket policy considerations for biosimilar oncology drugs. The Lancet Oncology 17:1, pages e31-e38.
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Sarfaraz Niazi. 2015. Biosimilars and Interchangeable Biologics. Biosimilars and Interchangeable Biologics 1 22 .
Pere Gascon. (2015) The evolving role of biosimilars in haematology–oncology: a practical perspective. Therapeutic Advances in Hematology 6:6, pages 267-281.
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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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Michael S. Kinch. (2015) An overview of FDA-approved biologics medicines. Drug Discovery Today 20:4, pages 393-398.
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L. Puig. (2014) Biosimilars and Reference Biologics: Decisions on Biosimilar Interchangeability Require the Involvement of Dermatologists. Actas Dermo-Sifiliográficas (English Edition) 105:5, pages 435-437.
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L. Puig. (2014) Biosimilares y biológicos de referencia: la intercambiabilidad de los biosimilares requiere la participación del dermatólogo. Actas Dermo-Sifiliográficas 105:5, pages 435-437.
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Zahra Shahrokh, Nazila Salamat‐Miller & John J. Thomas. 2014. Biophysical Methods for Biotherapeutics. Biophysical Methods for Biotherapeutics 317 353 .
Xing Jin, Sunmi Kang, Hyuknam Kwon & Sunghyouk Park. (2014) Heteronuclear NMR As a 4-in-1 Analytical Platform for Detecting Modification-Specific Signatures of Therapeutic Insulin Formulations. Analytical Chemistry 86:4, pages 2050-2056.
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Lutz Heinemann & Marcus Hompesch. (2014) Biosimilar Insulins. Journal of Diabetes Science and Technology 8:1, pages 6-13.
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Stephen J. Archibald. (2013) Antibody Radiolabeling Techniques To Optimize Cellular Retention. Journal of Medicinal Chemistry 56:23, pages 9415-9417.
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Stefano Menegatti, Amith D Naik & Ruben G Carbonell. (2013) The hidden potential of small synthetic molecules and peptides as affinity ligands for bioseparations. Pharmaceutical Bioprocessing 1:5, pages 467-485.
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H. Mellstedt. (2013) Anti-neoplastic biosimilars—the same rules as for cytotoxic generics cannot be applied. Annals of Oncology 24, pages v23-v28.
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Carl-Erik Flodmark, Katarina Lilja, Heike Woehling & Kajsa Järvholm. (2013) Switching From Originator to Biosimilar Human Growth Hormone Using Dialogue Teamwork: Single-Center Experience From Sweden. Biologics in Therapy 3:1, pages 35-43.
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I-H Song & J Sieper. (2013) Etanercept for the treatment of axial spondyloarthritis. Clinical Investigation 3:4, pages 343-357.
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L. Puig. (2013) Biosimilars in Dermatology: Starting With Infliximab. Actas Dermo-Sifiliográficas (English Edition) 104:3, pages 175-180.
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L. Puig. (2013) Biosimilares en dermatología: infliximab para empezar. Actas Dermo-Sifiliográficas 104:3, pages 175-180.
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Walter H. Hörl. (2013) Differentiating Factors Between Erythropoiesis-Stimulating Agents: An Update to Selection for Anaemia of Chronic Kidney Disease. Drugs 73:2, pages 117-130.
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Barbara Mounho-Zamora. 2013. Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics. Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics 159 184 .
Zayrho Desanvicente-Celis, Arley Gomez-Lopez & Juan-Manuel Anaya. (2012) Similar biotherapeutic products: overview and reflections. Immunotherapy 4:12, pages 1841-1857.
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Xin Xu & Yulia Vugmeyster. (2012) Challenges and Opportunities in Absorption, Distribution, Metabolism, and Excretion Studies of Therapeutic Biologics. The AAPS Journal 14:4, pages 781-791.
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F. Braido, S. Holgate & G.W. Canonica. (2012) From “blockbusters” to “biosimilars”: An opportunity for patients, medical specialists and health care providers. Pulmonary Pharmacology & Therapeutics 25:6, pages 483-486.
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Steven Simoens, Gilbert Verbeken & Isabelle Huys. (2012) Biosimilars and market access: a question of comparability and costs?. Targeted Oncology 7:4, pages 227-231.
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I.H. Song & W.P. Maksymowych. (2012) Therapeutic Controversies. Rheumatic Disease Clinics of North America 38:3, pages 613-633.
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Leon KerkhofsGilles Boschetti, Antonio Lugini, Dana-Lucia Stanculeanu & Andrés Garcia Palomo. (2012) Use of biosimilar epoetin to increase hemoglobin levels in patients with chemotherapy-induced anemia: real-life clinical experience. Future Oncology 8:6, pages 751-756.
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Matti Aapro, Paul Cornes, Diana Sun & Ivo Abraham. (2012) Comparative cost efficiency across the European G5 countries of originators and a biosimilar erythropoiesis-stimulating agent to manage chemotherapy-induced anemia in patients with cancer. Therapeutic Advances in Medical Oncology 4:3, pages 95-105.
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Pere Gascon. (2012) Presently available biosimilars in hematology-oncology: G-CSF. Targeted Oncology 7:S1, pages 29-34.
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Ran Zichel, Wanida Chearwae, Gouri Shankar Pandey, Basil Golding & Zuben E. Sauna. (2012) Aptamers as a Sensitive Tool to Detect Subtle Modifications in Therapeutic Proteins. PLoS ONE 7:2, pages e31948.
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Saul Malozowski. (2011) Biosimilars. Arquivos Brasileiros de Endocrinologia & Metabologia 55:8, pages 669-669.
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George Dranitsaris, Eitan Amir & Kristine Dorward. (2011) Biosimilars of Biological Drug Therapies. Drugs 71:12, pages 1527-1536.
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Simon J. Teague. (2011) Learning lessons from drugs that have recently entered the market. Drug Discovery Today 16:9-10, pages 398-411.
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S. Simoens, G. Verbeken & I. Huys. (2011) Market access of biosimilars: not only a cost issueL’accès au marché par les biosimilaires: pas seulement un problème de coût. Oncologie 13:5, pages 218-221.
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P. Gascon. (2011) Presently available biosimilars in hematology-oncology — Part II: G-CSFBiosimilaires actuellement disponibles en hémato-oncologie — Partie II: G-CSF. Oncologie 13:5, pages 213-217.
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Jorge Mestre-Ferrandiz & Adrian Towse. (2014) What is the Role of HTA for Biosimilars?. SSRN Electronic Journal.
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