Skip to main content

An Evidence-Based Practice Approach to Evaluating Biotechnologically Derived Medications

  • Chapter
  • First Online:
Pharmaceutical Biotechnology

Abstract

Recent advances in pharmaceutical biotechnology have led to the development of many different therapeutic proteins. These technologies have given credence to the legitimate promise that we, at some point, may be able to more closely match some specific patients with the most effective and safe drugs at an individualized dose—personalized/precision medicine. Importantly, these therapeutic proteins should be incorporated into clinical practice just like any other treatment option, which is by using the best available evidence and balancing benefits and harms.

This is a preview of subscription content, log in via an institution to check access.

Access this chapter

Chapter
USD 29.95
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
eBook
USD 89.00
Price excludes VAT (USA)
  • Available as EPUB and PDF
  • Read on any device
  • Instant download
  • Own it forever

Tax calculation will be finalised at checkout

Purchases are for personal use only

Institutional subscriptions

Similar content being viewed by others

References

  • Andabaka T, Nickerson JW, Rojas-Reyes MX, Rueda JD, Bacic Vrca V, Barsic B (2013) Monoclonal antibody for reducing the risk of respiratory syncytial virus infection in children. Cochrane Database Syst Rev 4:CD006602

    Google Scholar 

  • Blauvelt A, Papp KA, Griffiths CEM et al (2017) Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the continuous treatment of patients with moderate to severe psoriasis: results from the phase III, double-blinded, placebo- and active comparator-controlled VOYAGE 1 trial. J Am Acad Dermatol 76:405–417

    Article  CAS  Google Scholar 

  • ElDib R, Gomaa H, Carvalho RP, Camargo SE, Bazan R, Barretti P, Barreto FC (2016) Enzyme replacement therapy for Anderson-Fabry disease. Cochrane Database Syst Rev 7:CD006663

    Google Scholar 

  • Eng CM, Guffon N, Wilcox WR, Germain DP, Lee P, Waldek S et al (2001) Safety and efficacy of recombinant human alpha-galactosidase A replacement therapy in Fabry’s disease. N Engl J Med 345:9–16

    Article  CAS  Google Scholar 

  • Saag KG, Petersen J, Brandi ML, Karaplis AC, Lorentzon M, Thomas T, Maddox J, Fan M, Meisner PD, Grauer A (2017) Romosozumab or alendronate for fracture prevention in women with osteoporosis. N Engl J Med 377:1417–1427

    Article  CAS  Google Scholar 

  • Sabatine MS, Giugliano RP, Keech AC, Honarpour N, Wiviott SD, Murphy SA, Kuder JF, Wang H, Liu T, Wasserman SM, Sever PS, Pedersen TR, FOURIER Steering Committee and Investigators (2017) Evolocumab and clinical outcomes in patients with cardiovascular disease. N Engl J Med 376:1713–1722

    Article  CAS  Google Scholar 

  • Sindelar RD (2013) Genomics, other “Omic” technologies, personalized medicine. In: Crommelin DJA, Sindelar RD, Meibohm B (eds) Pharmaceutical biotechnology, 4th edn. Springer, New York, pp 190–221

    Google Scholar 

  • Wenzel S, Castro M, Corren J, Maspero J, Wang L, Zhang B, Pirozzi G, Sutherland ER, Evans RR, Joish VN, Eckert L, Graham NM, Stahl N, Yancopoulos GD, Louis-Tisserand M, Teper A (2016) Dupilumab efficacy and safety in adults with uncontrolled persistent asthma despite use of medium-to-high-dose inhaled corticosteroids plus a long-acting beta2 agonist: a randomised double-blind placebo-controlled pivotal phase 2b dose-ranging trial. Lancet 388:31–44

    Article  CAS  Google Scholar 

  • Wilcox WR, Banikazemi M, Guffon N, Waldek S, Lee P, Linthorst GE, Desnick RJ, Germain DP, International Fabry Disease Study Group (2004) Long-term safety and efficacy of enzyme replacement therapy for Fabry disease. Am J Hum Genet 75:65–74

    Article  CAS  Google Scholar 

Download references

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to James P. McCormack .

Editor information

Editors and Affiliations

Rights and permissions

Reprints and permissions

Copyright information

© 2019 Springer Nature Switzerland AG

About this chapter

Check for updates. Verify currency and authenticity via CrossMark

Cite this chapter

McCormack, J.P. (2019). An Evidence-Based Practice Approach to Evaluating Biotechnologically Derived Medications. In: Crommelin, D., Sindelar, R., Meibohm, B. (eds) Pharmaceutical Biotechnology. Springer, Cham. https://doi.org/10.1007/978-3-030-00710-2_13

Download citation

Publish with us

Policies and ethics