Biological medicines, including biosimilar medicines

Essential CPE module for pharmacists

This module discusses the use of biosimilar medicines in Australia. It provides information to enable pharmacists support patients, their families and carers using biosimilar medicines.

After completing this activity, pharmacists should be able to:

  • Discuss the terms ‘biological medicine’, ‘reference medicine’, ‘reference product’, ‘originator brand’ and ‘biosimilar medicine’.
  • Explain the relationship between reference medicines and biosimilar medicines.
  • Describe the various manufacturing processes to develop biological medicines, including biosimilar medicines.
  • Explain batch-to-batch variation and how this can have implications on acceptance of biosimilar medicine use.
  • Interpret the global and Australian landscape in terms of biological and biosimilar medicines.
  • List commonly used and approved biological medicines, including biosimilar medicines available in Australia.
  • Explain the nomenclature of monoclonal antibodies.
  • Describe the approval process for biosimilar medicines in Australia, including evaluation of efficacy, safety, immunogenicity and quality.
  • Describe government initiatives to reduce costs and increase access to biosimilar medicines.
  • List conditions managed or treated with biological medicines, including biosimilars.
  • Discuss the advantages of having access to biosimilar medicines in Australia, including for the patient and healthcare system.
  • Describe the approval process for biosimilar medicines by the Pharmaceutical Benefits Advisory Committee for addition to the Pharmaceutical Benefits Scheme.
  • Compare how the patient journey can differ for biological medicines, including biosimilars, and the importance of patient consultation.
  • Explain ‘a-flagging’ and ‘b-flagging’ and authority to switch between a reference medicine and biosimilar medicine.
  • Discuss differences between biosimilar use in the community and the hospital setting, including approval for use by Drug and Therapeutics Committee’s and Individual Patient Use applications.
  • Apply knowledge to case scenarios regarding initiation of biosimilar medicines and switching between reference medicines and biosimilar medicines.