In brief

In this article, we take a look at Australia’s standing in the global biosimilars market and factors affecting the uptake of biosimilar medicines in Australia.

Biosimilars market

Biosimilars are becoming increasingly prevalent across the globe as the patent thickets covering reference biologic medicines are slowly expiring. The value of the global biosimilars market was estimated to be USD 9.5 billion in 2022, and is expected to rise in the next decade to USD 33.4 billion in 2032.^[1] The factors driving this growth include:

• increasing demand for lower-cost biologic medicines;
• increasing government funding and regulatory support for biosimilars;
• increasing acceptance of biosimilars by healthcare providers and patients;
• various factors leading to a greater incidence of diseases and disorders, especially chronic diseases, including an ageing population and lifestyle factors such as longer working hours, poor dietary habits and insufficient sleep;
• a renewed focus on research and development by the pharmaceutical industry; and
• improvement in, and expansion of, pharmacy facilities.

The biosimilars market in Australia is expected to reach USD 814.4 million this year,^[2] and rise to USD 2 billion by 2027.

Biosimilar uptake in Australia

In comparison to other nations, the early market uptake of biosimilar medicines in Australia was comparatively slow. The limited uptake appeared to arise from at least:

• the reluctance of healthcare practitioners, at least in certain fields, to switch patients from the originator biologic medicine to a biosimilar medicine; and
• the reluctance of patients to switch to a biosimilar medicine, whether arising from their doctor’s views or otherwise.

In order to counter this, in 2015, as part of the Pharmaceutical Benefits Scheme Access and Sustainability Package, the Australian government committed $20 million over three years towards an awareness and educational campaign aimed at increasing biosimilar uptake.

Further, in 2017, the government reached agreement with Medicines Australia, the Generic and Biosimilar Medicines Association (GBMA) and the Pharmacy Guild of Australia to implement biosimilar uptake drivers. The two specific biosimilar uptake drivers were aimed at:

• encouraging prescribing of a biosimilar brand rather than the reference biologic brand for treatment naïve patients; and
• providing for a simpler and faster approval process for prescribing biosimilar brands (e.g. streamlined authority) while maintaining an existing higher level authority requirement for the reference biologic brand (e.g. written authority).

The first application of the biosimilar uptake drivers was on 1 December 2017 for Brenzys®, a biosimilar brand of etanercept.

In 2018-19, the government included further measures to increase the uptake of generic and biosimilar medicines, including the provision of over $5 million over three years to the GBMA to continue the biosimilar medicines awareness campaign established in 2015.

The table below identifies the increase in ARTG registrations and PBS listings of biosimilar medicines since 2013, specifically:

• in plain text (e.g. “2”), the number of biologic medicines for which a biosimilar had been ARTG registered or PBS listed;
• in italics and parentheses (e.g. “(3)”), the total number of biosimilar brands (noting that where a single sponsor has more than one brand for the same product (e.g. Cipla markets its bevacizumab biosimilar under the brands “Bevaciptin” and “Bevacip”), for the purposes of this table they are considered to be a single “brand”).

As at 1 January	Biosimilar competition: ARTG Registered (# of brands)	Biosimilar competition: PBS listed (# of brands)
2013	2 (3)	2 (2)
2014	2 (4)	2 (3)
2015	3 (5)	2 (3)
2016	5 (7)	3 (4)
2017	6 (9)	4 (5)
2018	8 (12)	5 (7)
2019	10 (18)	5 (7)
2020	11 (26)	7 (11)
2021	14 (32)	8 (16)
2022	14 (38)	11 (23)
2023	15 (43)	11 (26)

^{*Note: These figures include reference biologic medicines which were withdrawn following biosimilar competition, namely: MabThera (1 April 2021), Avastin (1 June 2021), Herceptin (1 October 2021) and Forteo (1 January 2022).}

While the biosimilar uptake drivers have no doubt encouraged greater use of biosimilars in Australia in recent years, the growth in the number of brands with biosimilar competition is largely the result of the increasing development of biosimilar products over the last decade as patents protecting the reference biologics approach their expiry. Generic drugs and biosimilars are estimated to account for nearly two-thirds of the PBS in volume terms and this proportion is expected to increase.^[3]

To the future

While the uptake of biosimilar medicines was originally slow in Australia, the Australian government initiatives and industry bodies have worked to improve awareness regarding biosimilar medicines.

Real world evidence of global use of biosimilars should increasingly overcome clinicians’ reluctance to switch, while patent expiries and a number of economic factors should encourage an increasingly favourable environment for biosimilar medicines in Australia.