What lies ahead for Medical Affairs in 2018?
Written by Dr Niamh O’Reilly

The healthcare landscape is changing and companies providing products and services to the industry need to evolve to keep up. In the spirit of a New Year almost upon us, CRC has selected what we believe may be hot topics for the pharmaceutical and medical device industries in 2018.

Biosimilars – much ado about nothing?

The pharmaceutical industry is experiencing a second wave of patent expiry and some of the most successful biological drugs may soon have competition from biosimilar products. The Australian government has pledged to drive the uptake of biosimilars and so has implemented the ‘Biosimilar Awareness Initiative’ to support awareness of, and confidence in, the use of biosimilars (1). Furthermore, changes in the way doctors prescribe biosimilars and new pricing mechanisms are planned to take effect in 2018 (2). While the intention is to encourage greater uptake, controversy around biosimilars remains. So what’s fueling this controversy?

In 2017, the first biosimilar product dispensed largely in community pharmacy was listed on the Pharmaceutical Benefits Scheme. The product is eligible for ‘a-flagging’ meaning that, like generics, it could be substituted by the pharmacist at the point of dispensing without input from the prescribing clinician (3, 4). As shown in Table 1, generic medicines are simple molecules identical to the reference product (5), therefore switching from brand to generic products is considered safe. Biosimilars, on the other hand, are complex molecules that cannot be considered identical to the original brand and so switching between brand and biosimilar is causing some concern (5, 6). However, it is recognised that education is key to building confidence in biosimilars, and so for this reason industry representatives raised the alarm when a planned online government education resource for HCPs was cancelled (7). Yet HCPs and consumers need unbiased, consistent, responsive and user-friendly information developed by independent credible sources (4, 6). Indeed, with the introduction of many new biosimilars expected in 2018 and beyond, now is the time for companies to address concerns around potential issues with multiple switches, product interchangeability and other relevant matters that will impact patient care (4, 6). More to come on this topic in a future blog…

Table 1. Overview of the main differences between generics and biosimilars

Table reproduced from Biosimilars vs Generics (5).

Forging new paths in reimbursement

In a previous blog, we discussed the increasing need to establish new reimbursement pathways for products that do not fit existing funding mechanisms (8). Recently, one company endeavoured to forge a new pathway following multiple rejections by the PBAC. In this case, a proposal was put to government detailing a unique PBS ‘swap out’ deal reported to be successful in another country (9). The deal under consideration by government could see the introduction of a long-term portfolio funding arrangement with the sponsor that has multiple innovative products in their pipeline and an active R&D program. If successful, this innovative funding option could possibly establish a mechanism whereby access to newly approved medicines would be guaranteed for eligible patients. Now that this request has been made, it’s likely we will see more of these types of ‘solutions’ by other companies in 2018.

Regulatory changes for medical devices

Inadequate clinical evidence is said to be the leading cause of rejection of medical device registration submissions by the TGA (10). A recent update of the TGA’s clinical evidence guidelines for medical devices aims to address this issue by detailing how to conduct clinical evaluations and how to present data in a clinical evidence report (10). Furthermore, the European Commission recently introduced a new Medical Devices Regulation (MDR) detailing a number of changes to be implemented over the next three years regarding the registration of medical devices. In keeping with the Australian Regulatory Authority’s policy of harmonisation with European standards, this new framework will likely impact Australian companies (11). Indeed, the impact of these changes may become more evident in 2018 and beyond and so regulatory teams who have been educated on how to implement the changes will likely have a head start over the competition.

CRC’s capability model is designed to deliver strategic and forward-thinking Medical Affairs solutions that can be adapted to external change and so continue to build value for our clients at all stages of the drug development lifecycle.


  1. The Department of Health website. 2017. Biosimilar Awareness Initiative. Available at: http://www.health.gov.au/biosimilars
  2. Owen J. and Currey R. 2017. Government moves to legislate to increase generic and biosimilar medicine uptake and cut medicine prices. Available at: https://www.twobirds.com/en/news/articles/2017/australia/government-moves-to-increase-generic-and-biosimilar-medicine-uptake-and-cut-medicine-prices
  3. Rowley D. 2017. Brenzys lists amid ‘misinformation’. Pharma in Focus. Available at: http://www.pharmainfocus.com.au/news.asp?newsid=11810
  4. Scully R. P. 2015. The controversy over biosimilars: What’s the deal? Medical Republic. Available at: http://medicalrepublic.com.au/the-controversy-over-biosimilars-whats-the-deal/1592
  5. Amgen website. Biosimilars vs Generics. Available at: http://www.amgenbiosimilars.com/the-basics/biosimilars-versus-generics/
  6. McKinnon R. and Ward M. 2016. Safety considerations of biosimilars. Australian Prescriber. Available at: https://www.nps.org.au/australian-prescriber/articles/safety-considerations-of-biosimilars
  7. Rowley D. 2016. Key plank of biosim awareness dumped. Pharma in Focus. Available at: http://www.pharmainfocus.com.au/news.asp?newsid=11437
  8. O’Reilly N. 2017. The Challenges of Market Access. Available at: https://crcaustralia.com/media-releases/ – Link for November blog
  9. Brodie M. Govt weighs radical PBS ‘swap out’. Pharma in Focus. Available at: http://www.pharmainfocus.com.au/news.asp?newsid=12654
  10. Ahmadzada T. 2017. TGA publishes final Clinical Evidence Guidelines for Medical Devices. Brandwood Biomedical Blog. Available at: http://brandwoodbiomedical.com/tga-publishes-final-clinical-evidence-guidelines-for-medical-devices/
  11. Loh E. and Boumans R. 2017. Understanding Europe’s new Medical Devices Regulation. Emergo White Paper. Available at: https://www.emergogroup.com/resources/articles/whitepaper-understanding-europes-medical-devices-regulation