The Daring of Biosimilars
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Niosi J. Imitation and innovation new biologics, biosimilars and biobetters. Technology Analysis & Strategic Management. 2017; 29: 251-262. Ref.: https://goo.gl/1thHhm
Evens R, Kaitin K. The evolution of biotechnology and its impact on health care. Health Aff. 2015; 34: 210-219. Ref.: https://goo.gl/m1Zfoi
Richardson E. Biosimilars: To Encourage Competition, the Health Care Law Directs the FDA to Develop an Accelerated Approval Pathway for Follow-on Versions of Original Biologic Products. Health Aff. 2013; 1-5. Ref.: https://goo.gl/ZVhvQ7
Kesselheim AS, Darrow JJ. Hatch-Waxman Turns 30: Do we need a Re-Designed Approach for the Modern Era? Yale J Health Policy Law Ethics. 2015; 15: 293-347. Ref.: https://goo.gl/m60BcS
Walsh G. Biopharmaceutical Benchmarks. Nat Biotechnol. 2014; 32: 992-1000. Ref.: https://goo.gl/yCu0EM
Schietl M, Stangler T, Torella C, Čepeljnik T, Toll H, et al. Acceptable Changes in Quality Attributes of Glycosilated Biopharmaceuticals. Nat Biotechnol. 2011; 29: 310-312. Ref.: https://goo.gl/R0vV5m
EMA site. Available April 2017. Ref.: https://goo.gl/VAdNL
Grabowski HG, Guha R, Salgado M. Regulatory and cost barriers are likely to limit biosimilar development and expected savings in the near future. Health Aff. 2014; 33: 1048-1057. Ref.: https://goo.gl/ZrNzbC
Combest AJ, Wang S, Healey BT, Reitsma DJ. Alternative Statistical Strategies for Biosimilar Drug Development. Generic and Biosimilar Initiative Journal. 2014; 3: 13-20. Ref.: https://goo.gl/4Bs5ji