Abstract

Letter to Editor

The Daring of Biosimilars

Nuris Ledón* and Agustín Lage

Published: 01 May, 2017 | Volume 1 - Issue 1 | Pages: 017-020

The so-called “biotechnological revolution” is changing the structure of the Pharmacopoeia [1]. The space of biological products, previously limited to blood products and vaccines, grew from the introduction of first recombinant therapeutics in the 1980s until attaining a 25% by value of the pharmaceutical market. This share is expected to reach 50% in the coming years. More than 80 biotechnology drugs have entered the market in the last ten years. It is estimated that there are more than 900 biological products on development for more than 100 diseases [2].

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References

  1. Niosi J. Imitation and innovation new biologics, biosimilars and biobetters. Technology Analysis & Strategic Management. 2017; 29: 251-262. Ref.: https://goo.gl/1thHhm
  2. 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
  3. 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
  4. 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
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  6. 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
  7. EMA site. Available April 2017. Ref.: https://goo.gl/VAdNL
  8. 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
  9. 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

Figures:

Figure 1

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