Open Learning Course: The essentials of biologicals – past, present and future







Section 2 – Selection, Procurement and Distribution: Statements 2.1, 2.2, 2.3
Section 4 – Clinical Pharmacy Services: Statement 4.1
Section 5 – Patient Safety and Quality Assurance: Statement 5.6


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The evolution of biologicals started in the 1980s. Since then the rapidly evolving better understanding of biochemical and pathophysiological processes in the human body and progress in biologicals' development led to the arrival of more complex biologicals. In current medicine, biologicals are essential treatment options for a variety of diseases. The widespread use of these molecules, and the loss of patents enabled the advent of biosimilars of originator biologicals in 2006. This, on the one hand contributed the better access to therapies with biologicals but also led to an increased complexity when it comes to decision-making about the choice of medicines, interchangeability, switching, usage and monitoring of biologicals.

Hospital pharmacists have always accompanied and monitored these advancements of the therapeutic spectrum and contributed to the spread of knowledge about biologicals and debunking myths about biosimilars. Key topics in the field of biologicals are quality and safety-related aspects, clinical aspects and economics aspects. These three main topics will be addressed in the perspective of past developments, the present situation and future challenges.

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After the synergy session, the participant should be able to:

  • Recall major quality criteria of biologicals;
  • Recap the biosimilar concept with regard to the development and authorization procedure;
  • List facts about the economic impact of originator biologics and biosimiliars and their influence with regard to equitable medicines access; and,
  • Outline the issues of switching and interchangeability of biologicals.
As hospital pharmacists are responsible for selecting and assessing biologicals and biosimilars and monitoring their use, they need to have an in-depth understanding of key principles regarding quality, safety and efficacy.

Bioequivalence, Biosimilars, Biotechnology, Compounding, Drug Manufacturing, Pharmacodynamics, Pharmacoeconomics, Quality Assurance, Safety

Last update: 8 August 2018