Biological medicines are available in Australia for the treatment of serious diseases such as cancers, diabetes, rheumatoid arthritis, severe psoriasis, kidney disease, multiple sclerosis, and inflammatory bowel diseases such as ulcerative colitis and Crohn’s disease.
Biological medicines have revolutionised medical care due to their targeted efficacy, speed of onset and tolerability, however, they represent a significant part of healthcare spending. In 2016, six of the top ten drugs by cost to the Australian government were biological medicines.1
As originator biologics reach the end of their patents, other manufacturers are able to produce highly similar versions of these medicines, known as biosimilars.
Importantly, biosimilars provide an opportunity to help support the sustainability of the PBS.
Regulatory authorities acknowledge that while there may be some variability between the originator biological medicine and a biosimilar, these differences are minor and do not affect safety or efficacy of biosimilars.2
There is a great deal of confusion surrounding biosimilars and pharmacists play a key role in discussing the safety and efficacy considerations with their patients as well as assisting with pharmacovigilance by reporting any adverse events that are witnessed in practice.
Guild Learning and Development is partnering with MSD Australia Pty Ltd in an online course titled ‘Biosimilars in focus’. This is the first of two courses to be launched on this topic and a second course focusing on Brenzys® (etanercept) will be launched in the next few weeks.
The learning objectives for this online course are:
- Define biological medicine and identify differences between biological medicines and small-molecule medicines
- Define biosimilar medicine and outline why biosimilar medicines are not the same as generic medicines
- Explain the manufacturing process for biological medicines
- Outline the regulatory pathways for licensing a biosimilar and the assessments required for their approval
- Understand the concepts of extrapolation, interchangeability and substitution as related to biosimilar products
- Explain the importance of pharmacovigilance in the use of biosimilars
- Discuss the safety and efficacy considerations for biosimilar medicines
- Discuss how the availability of biosimilars provides an opportunity to help support the sustainability of the PBS.
This activity has been accredited for 1 hour of Group 1 CPD (or 1 CPD credit), suitable for inclusion in an individual pharmacist’s CPD plan, which can be converted to 1 hour of Group 2 CPD (or 2 CPD credits) upon successful completion of relevant assessment activities.
Accreditation code G2017041.
To enrol in this course please visit myCPD.org.au.
Please contact Guild Learning and Development on 03 9810 9930 or email firstname.lastname@example.org for more information.
Guild Learning and Development thanks MSD Australia Pty Ltd for their financial support and assistance in the development of this course.
1. Aust Prescr (2016). Top 10 drugs. Australian Prescriber. 39 (6).
2. EMA. (2017). Biosimilars in the EU: Information guide for healthcare professionals. European Medicines Agency. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Leaflet/2017/05/WC500226648.pdf. Accessed July 2017