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This course looks at biological medicines and biosimilars. Compared to conventional small molecule drugs, biological medicines are larger and more complex molecules. While there are many types of biological medicines, the majority are therapeutic proteins, and these are the focus of this course.

The programme should take approximately 2 hours to complete.

The learning objective is met through achievement of the learning outcomes below.

At the end of this module, pharmacists will be able to;

  • Understand how biological medicines are developed and approved by regulatory agencies
  • Describe the legal and regulatory considerations important to clinical practice
  • Define biosimilars
  • Understand the safety considerations if switching brands of a biological medicine
  • Discuss the importance of education for healthcare professionals and patients

The course is laid out in six lessons followed by case-based scenarios.

Lesson 1: Biological Medicines – an Introduction

  • Understand why biological medicines are important for you and your patient
  • Outline the history of the development of biological medicines
  • Understand the key differences between small molecule medicines and biological medicines

Lesson 2: Development of Biological Medicines

  • Understand that the living organisms used to produce a biological medicine are naturally variable
  • Understand how the product is defined by the manufacturing process for biological medicines
  • Outline the scientific principles used to ensure that quality, safety and efficacy is consistently maintained
  • Discuss the concept of immunogenicity and its importance

Lesson 3: Biosimilars

  • Define a biosimilar
  • Outline key differences between biosimilar and novel biological medicine regulatory pathways
  • Understand how scientific principles used to ensure batch to batch similarity for the reference medicine are used to confirm biosimilarity
  • Potential advantages biosimilars bring for the patient

Lesson 4: Interchangeability

  • Define interchangeability, switching and automatic substitution
  • Outline current regulations and legislation in Ireland
  • Knowledge of recommendations relating to switching in the Irish health service
  • Knowledge of the management of biological medicines on the High Tech Hub

Lesson 5: Pharmacovigilance

  • Understand that the safety considerations for a biosimilar and its reference medicine are the same
  • Understand all newly approved biological medicines are “black triangle”
  • Understand that traceability is essential for pharmacovigilance of biological medicines

Lesson 6: Education

  • On successful completion of this section, you will be able to discuss the importance of education and the role of pharmacists

Lesson 7: Case-based Scenarios