1Smeeding J, Malone DC, Ramchandani M, Stolshek B, Green L, Schneider P (2019) Biosimilars: Considerations for Payers. P T. Jan 44:54-63.
2Ventola CL (2013) Biosimilars: part 1: proposed regulatory criteria for FDA approval. P T. 38 :270-87.
3Patel KB, Arantes LH Jr, Tang WY, Fung S (2018) The role of biosimilars in value-based oncology care. Cancer Manag Res. 2018 Oct 17; 10:4591-4602.
4Barbier L, Declerck P, Simoens S, Neven P, Vulto AG, Huys I (2019) The arrival of biosimilar monoclonal antibodies in oncology: clinical studies for trastuzumab biosimilars. Br J Cancer.
5Blackstone EA, Joseph PF (2013) The economics of biosimilars. Am Health Drug Benefits.
6Epstein M (2018) Food and Drug Administration guidances on biosimilars: an update for the gastroenterologist. Therap Adv Gastroenterol.
7Burchiel SW, Aspbury R, Munday J. (2019) The search for biosimilars and biobetters. Drug Discov Today 24:1087-1091.
8Calo-Fernández B, Martínez-Hurtado JL (2012) Biosimilars: company strategies to capture value from the biologics market. Pharmaceuticals (Basel). 5:1393-408.
9Calvo B, Zuñiga L (2012) The US approach to biosimilars: the long-awaited FDA approval pathway. BioDrugs. 26:357-61.
10Barlas S (2012) FDA Readies New Guidance and User Fee Program for Biosimilars: Drug interchangeability and user fees are contentious issues the FDA must resolve. Is the FDA up to the task? Biotechnol Healthc. Summer 9:28-9.
11Karateev D, Belokoneva N (2019) Evaluation of Physicians' Knowledge and Attitudes Towards Biosimilars in Russia and Issues Associated with Their Prescribing. Biomolecules. 9 :2.
12Weise M (2019) From bioequivalence to biosimilars: How much do regulators dare? Z Evid Fortbild Qual Gesundhwes. 140:58-62.
13Kirchhoff CF, Wang XM, Conlon HD, Anderson S, Ryan AM, Bose A (2017) Biosimilars: Key regulatory considerations and similarity assessment tools. Biotechnol Bioeng. 12:2696-2705.
14Mark H. Lee, Patrick Au, John Hyde, Carmen Gacchina Johnson, Mohammad Heidaran, et al. (2014)Translation of Regenerative Medicine Products Into the Clinic in the United States: FDA Perspective. In: Anthona Atala and Julie Allickson. Translational Regenerative Medicine.
15(2013) Biosimilar Medicines. Pharma Mirror Magazine.
16Chapter 2 (2019) Biopharmaceuticals are not Chemical Drugs. In: John Geigert. The Challenge of CMC Regulatory Compliance for Biopharmaceuticals and Other Biologics.
17Chen Y-C, Yeh M-K. (2018) Chapter 1. Biopharmaceuticals. DOI: 10.5772/intechopen.79194. In: Yuan-Chuan Chen and Ming-Kung Yeh. Biopharmaceuticals.
18National Research Council (US) (2003) Committee on Challenges for the Chemical Sciences in the 21st Century. Beyond the Molecular Frontier: Challenges for Chemistry and Chemical Engineering. Washington (DC): National Academies Press (US); 2003. 3, Synthesis and Manufacturing: Creating and Exploiting New Substances and New Transformations.
19Jacquemart R, Vandersluis M, Zhao M, Sukhija K, Sidhu N, Stout J (2016) A Single-use Strategy to Enable Manufacturing of Affordable Biologics. Comput Struct Biotechnol J. 2016 Jul 5;14:309-18. doi: 10.1016/j.csbj.2016.06.007. eCollection. Review.
20Chan JCN, Chan ATC (2017) Biologics and biosimilars: what, why and how?. ESMO Open.
21Patel PK, King CR, Feldman SR (2015) Biologics and biosimilars. J Dermatolog Treat. 26:299-302.
22Scavone C, Rafaniello C, Berrino L, Rossi F, Capuano A (2017) Strengths, weaknesses and future challenges of biosimilars' development. An opinion on how to improve the knowledge and use of biosimilars in clinical practice. Pharmacol Res.
23Feagan B. Benefits (2017) Concerns, and Future Directions of Biosimilars in Inflammatory Bowel Disease. Gastroenterol Hepatol (N Y). 13:745-747.
24Cronstein BN (2015) The benefits and drawbacks of biosimilars. Clin Adv Hematol Oncol. 13:639-41.
25Uhlig T, Goll GL (2017) Reviewing the evidence for biosimilars: key insights, lessons learned and future horizons. Rheumatology (Oxford). 1: 56 iv49-iv62.
26Yoo DH (2014) The rise of biosimilars: potential benefits and drawbacks in rheumatoid arthritis. Expert Rev Clin Immunol. 10:981-983.
27Leonard E, Wascovich M, Oskouei S, Gurz P, Carpenter D (2019) Factors Affecting Health Care Provider Knowledge and Acceptance of Biosimilar Medicines: A Systematic Review. J Manag Care Spec Pharm.
28McKinnon R, Ward M (2016) Safety considerations of biosimilars. Aust Prescr.39 :188-189.
29Kowalski SC, Benavides JA, Beltrán PA, Roa PAB, Galarza-Maldonado C, et al. (2019) PANLAR consensus statement on biosimilars. Clin Rheumatol. 38:1485-1496.
30Declerck P, Danesi R, Petersel D, Jacobs I (2017) The Language of Biosimilars: Clarification, Definitions, and Regulatory Aspects. Drugs. 77:671-677.