Biosimilar Policy Roadmap: New Report Highlights the Need for Australia to Establish a Sustainable Biosimilar Market

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September 7, 2022 2:25 am EDT

Findings show that Australia’s policy framework is falling behind most countries in supporting biosimilar uptake, which has shown to support the health budget, healthcare providers and patient choice.

CANBERRA, 7 September 2022 – Organon, a global women’s healthcare company, announced the release of the ‘Biosimilars: A global roadmap for policy sustainability’ at Parliament House today.[i]  The report highlights the need for urgent policy reform that provides multi-stakeholder benefits that should be realised in the long term for a sustainable biosimilar environment.1 The report presents key policy recommendations that can support the long-term national adoption of biosimilars to provide access for patients, bolster supply, reduce expenses for the healthcare system and PBS reimbursements.1

The international biosimilar pipeline continues to evolve as biologics in new therapeutic areas near patent expiry.1 Biosimilars have been shown not to have any clinical meaningful differences from the originator medicine in terms of quality, safety and efficacy.1 While countries such as the United States, the United Kingdom and France allow automatic reimbursement following regulatory approval, biosimilars must still undergo a lengthy Health Technology Assessment (HTA) process to receive reimbursement in Australia.1

George Tambassis, Co-Author and Chair of the Australian Biologics Academy says, “A sustainable biologics market is one where all stakeholders, including patients, have reliable and consistent access to biological therapies. However, this is highly dependent on the nature of the policy framework to support the uptake of biosimilars. Ultimately, Australia should aim for competition within the biosimilar market and incentives for patients, to ensure a sustainably functioning environment that allows the best value for innovation without compromising quality.”

This report highlights numerous priorities to achieve long-term sustainability of biosimilars in Australia, including:1

  • Ensure alignment of financial incentives that benefit all key stakeholders, including physicians, pharmacists and patients
  • Decrease patient co-payments applied for biosimilars to enable cost savings not only for payers but for a broader range of stakeholders including patients
  • Increase multi-disciplinary decision-making regarding dispensing of biosimilars to ensure the best outcomes for the patients and best value for the healthcare system.
  • Optimise existing pricing and reimbursement policy to mitigate the impact of erosion driven by mandatory discounts and considers the differences across therapeutic areas, the number of competitors and population size.

Ms Marnie Peterson, CEO at Generic Biosimilar Medicines Association (GBMA) says the peak body for affordable medicines and its members have been working with Government to drive awareness and confidence among patients and their healthcare professionals. The GBMA is further looking forward to co-designing policies aimed at driving the uptake of biosimilars.

“We know biosimilars can, and will, unlock significant savings for our overwhelmed health budget,” Ms Peterson said. “And we can go further with policies that provide even greater relief at the hip pocket for Australians already struggling with the rising cost of living. It is a win-win for taxpayers and patients.”

Luke Cornish, Director Access & External Affairs at Organon says, “With the right policy settings, biosimilars have the potential to reduce healthcare costs and contribute to a sustainable PBS. Savings can be used to broaden access to patients who currently miss out and to reinvest into new medicines. This report outlines the simple steps the Government can take to make sure Australia benefits from the full potential of biosimilar medicines.”

For further information about the report, visit:


Media Contacts:

Meshlin Khouri Organon 0446 276 553Melissa Quinon WE Communications 0410 500 014

About Organon

Organon (NYSE: OGN) is a global healthcare company formed through a spin-off from Merck & Co., Rahway, NJ, USA (NYSE: MRK) known as MSD outside of the United States and Canada, focused on improving the health of women throughout their lives. Here for her health, the company has a portfolio of more than 60 medicines and products across a range of therapeutic areas. Led by the reproductive health portfolio coupled with an expanding biosimilars business and stable franchise of established medicines, Organon’s products produce strong cash flows that will support investments in future growth opportunities in women’s health. In addition, Organon is pursuing opportunities to collaborate with biopharmaceutical innovators looking to commercialize their products by leveraging its scale and presence in fast growing international markets.

Organon has a global footprint with significant scale and geographic reach, world-class commercial capabilities, and approximately 9,000 employees with headquarters located in Jersey City, New Jersey, USA.


[1] Wilsdon T, Pistollato M, Ross-Stewart Kirsty, Saada R, Barquin P. Biosimilars: A global roadmap for policy sustainability 2022. Charles River Associates.

Copyright © 2022 Organon Group of Companies. All rights reserved. Organon and the organon Logo are trademarks of the Organon Group of companies. Organon Pharma Pty Ltd (Organon). Building A Level 3, 26 Talavera Road, Macquarie Park NSW 2113.

AU-NON-110118. First Issued September 2022.