Samsung Bioepis and Organon Expand Australian Biosimilar Partnership to Four Products as PBS Default Reform Looms
Key Insights
Samsung Bioepis (search) and Organon announced expansion of their commercialization agreement to bring a fourth biosimilar product to Australia via Organon ANZ, deepening a partnership now in its thirteenth year.
Australia's biosimilar market reached approximately USD $906 million in 2025 and is forecast to reach USD $6.7 billion by 2034, yet anti-TNF (search) biosimilar uptake in retail pharmacy sits at just 36 percent, well below the OECD average of 67 percent.
The 2026–27 Federal Budget included a commitment to reviewing whether biosimilars should become the default for new prescriptions, a reform the GBMA estimates could free up to $1.5 billion in PBS headroom over five years.
Samsung Bioepis (search) and Organon announced on July 16, 2026 that they are expanding their long-running development and commercialization agreement to bring a fourth biosimilar product to Australia through Organon ANZ. The product's identity was not disclosed, but the announcement underscores the accelerating pace of the partnership: the two companies added a sixth biosimilar to their Canadian portfolio just four weeks prior.
Under the terms of the agreement, Organon will obtain exclusive commercial rights to the product in Australia, while Samsung Bioepis (search) will maintain full development, manufacturing, and regulatory responsibilities. The collaboration, now in its thirteenth year, follows a division-of-labor model in which Samsung Bioepis handles preclinical and clinical development, process development, manufacturing, and regulatory filings from its Songdo campus in Incheon, South Korea, while Organon manages market access, prescriber engagement, and PBS listing logistics through its local subsidiary.
"This expanded agreement reflects Samsung Bioepis (search)' enduring commitment to widening global access to biosimilars," said Jinhan Chung, Vice President and Head of Commercial Strategy for International Markets, Samsung Bioepis.
Martie de Villiers, Biosimilars Business Unit Manager at Organon ANZ, added: "In Australia, biosimilars play a vital role in expanding choices available to patients and healthcare professionals while supporting the financial sustainability of the healthcare system. Strong partnerships are critical to achieving this effort."
Australia's Biosimilar Market: Rapid Growth, Lagging Uptake
Australia's biosimilar sector reached approximately USD $906 million in 2025 and is forecast to reach USD $6.7 billion by 2034, representing a compound annual growth rate of roughly 21 percent, according to IMARC Group's Australia biosimilar market forecast. That trajectory is powered by expiring patents on blockbuster biologics, a supportive regulatory framework at the Therapeutic Goods Administration (TGA), and a government increasingly willing to push biosimilar uptake through policy rather than education alone.
Yet there is a gap between that growth story and clinical reality. Australia's uptake of anti-TNF (search) biosimilars in retail pharmacy sits at just 36 percent — well below the OECD average of 67 percent, according to MBIP's analysis of Sandoz market data. Several forces explain the lag, including limited automatic substitution policies, slower prescriber adoption, and the absence of blunt demand-side mechanisms such as mandatory biosimilar prescribing for treatment-naive patients that have accelerated uptake in countries like Germany and Norway.
The PBS Pricing Mechanism and Documented Savings
The mechanism through which biosimilar market entry generates savings is specific to the Pharmaceutical Benefits Scheme (PBS) architecture. When the first biosimilar brand of a biologic medicine is listed on the PBS, a statutory price reduction of up to 25 percent is triggered on all brands of that reference product — including the originator — under Division 3A of Part VII of the National Health Act 1953. After that initial cut, the government's price disclosure policy takes effect: manufacturers must periodically report actual transaction prices, and the government ratchets the PBS reimbursement price down to reflect that weighted average.
A peer-reviewed analysis published in Value in Health Regional Issues examined four biologics — etanercept, infliximab, rituximab, and trastuzumab — and found that just twelve months after biosimilar market entry, spending on each reference product fell by 38.3 percent, even as overall prescription volumes grew by nearly 5 percent. A separate analysis covering the decade from 2015 to 2025 found that TNF (search) inhibitor biosimilars alone generated approximately AU$562 million in cumulative PBS savings, with etanercept contributing the largest share at roughly AU$341 million.
According to an analysis estimating the historical and future financial impact of biosimilars on PBS expenditure, biosimilars have already generated $1.03 billion in savings through the PBS from 2015 to 2022, with an additional $3.87 billion in savings potentially achievable between 2023 and 2027.
The Default Prescribing Consultation
The 2026–27 Federal Budget included a commitment to reviewing whether biosimilars should become the default for new prescriptions. The Generic and Biosimilar Medicines Association (GBMA) estimates the reform could free up as much as $1.5 billion in PBS headroom over five years — savings that could be reinvested in funding innovative medicines.
Paul Asten, Business Manager for Customer, Trade and Partnerships at Organon ANZ, framed the partnership's significance in this context: "Our partnership with Samsung Bioepis (search) not only creates greater access to biosimilars but also unlocks PBS savings that can be reinvested into funding innovative medicines for Australian patients. That is why we are proud to strengthen our longstanding relationship with Samsung Bioepis, one of Organon's key global collaborators."
The consultation is examining whether new patients starting biologic treatment would be prescribed a biosimilar by default unless a clinician specifies otherwise. Patients already stable on a biologic would not be affected. The focus is on treatment-naive patients, where prescribing a biosimilar from the first prescription carries no clinical risk of disruption and captures the full cost benefit.
Existing Portfolio and Prescriber Confidence
Three Samsung Bioepis (search) biosimilars already commercialized by Organon have Australian PBS listings: Brenzys (etanercept, referencing Enbrel, listed since 2017), Renflexis (infliximab, referencing Remicade, listed since 2017), and Hadlima (adalimumab, referencing Humira, listed from 2021). A fourth — Ontruzant (trastuzumab, referencing Herceptin) — has been in the Australian market since January 2020. Today's announcement adds a fifth commercial product to the overall relationship and brings the Australia collaboration specifically to four named products.
Prescriber familiarity with existing products provides meaningful context. Early anti-TNF (search) biosimilar market entries in Australia saw first-year market shares of just 2 percent for both etanercept and infliximab, but by the most recent year of study data, biosimilars had grown to represent 26 to 39 percent of total unit volume across those products. Rituximab and trastuzumab biosimilars, with later launch dates, achieved first-year market shares of 32.5 and 14.8 percent respectively, consistent with a pattern of accelerating prescriber confidence over time.
The TGA approved 65 biosimilars as of 2024, with a record 22 new approvals in that year alone, including denosumab biosimilars and the first natalizumab biosimilar Tyruko in early 2025.
Sun Pharma Acquisition Adds Strategic Weight
In April 2026, India's Sun Pharmaceutical Industries announced it would acquire Organon in an all-cash transaction valued at USD $11.75 billion — the largest overseas pharmaceutical acquisition by an Indian company in history. The deal, expected to close in early 2027 subject to regulatory and shareholder approvals, would make the combined entity the seventh-largest seller of biosimilars globally.
Organon's biosimilars segment has been growing at approximately 13 percent annually, representing around 11 percent of total revenues. The Australia market, with its projected 21 percent CAGR, represents a meaningful slice of the Asia-Pacific biosimilar geography. Under the terms of the Samsung Bioepis (search)–Organon collaboration, commercialization rights currently held by Organon would pass to the combined Sun Pharma–Organon entity upon close.
Samsung Bioepis (search) has stated plans to develop more than 10 additional biosimilar candidates by 2030, targeting oncology and autoimmune disorder categories where patent protection on high-cost biologics is approaching expiry globally. The company has supplied more than 85 million units across more than 40 countries without major supply disruptions.
What Comes Next
The undisclosed product will need to clear two gates before subsidized patient access is possible: TGA registration and a Pharmaceutical Benefits Advisory Committee (PBAC) recommendation for PBS listing. What the deal announcement does not change, on its own, is prescriber behavior. The research is consistent: the PBS pricing mechanism delivers its full savings potential only when biosimilar market share is high enough to force competitive discounting. Australia's 36 percent anti-TNF (search) uptake rate has left documented savings on the table compared to markets with higher uptake rates or active biosimilar mandates.
Without prescriber behavior change driven by the default prescribing consultation, expanding what is commercially available remains a necessary but not sufficient condition for realizing the $1.5 billion in PBS headroom the GBMA estimates is achievable.