Organon partners to launch new biosimilar

Organon ANZ and Samsung Bioepis have expanded their Development and Commercialisation Agreement, paving the way for the launch of a new biosimilar medicine in Australia.

Under the expanded agreement, Organon will secure exclusive commercial rights for Epyztek, a biosimilar to Johnson & Johnson Innovative Medicine’s Stelara (ustekinumab) for autoimmune conditions, which has already received a positive recommendation from the Pharmaceutical Benefits Advisory Committee (PBAC) for reimbursement. Samsung Bioepis will retain responsibility for the medicine’s ongoing development, manufacturing and regulatory activities.

“We are proud to build on our longstanding partnership with Organon to expand the availability of our biosimilar portfolio for Australian patients. This expanded agreement reflects Samsung Bioepis’ enduring commitment to widening global access to biosimilars,” said Jinhan Chung, Vice President and Head of Commercial Strategy for International Markets.

“By remaining committed to upholding development, manufacturing and regulatory excellence, we aim to help more patients access the treatments they need while contributing to the long-term sustainability of Australia’s healthcare system,” Chung added.

Organon already commercialises a portfolio of Samsung Bioepis biosimilars, including Hadlima (adalimumab), Brenzys (etanercept), Renflexis (infliximab), Aybintio (bevacizumab), and Ontruzant (trastuzumab), all of which are reimbursed through the Pharmaceutical Benefits Scheme (PBS).

“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,” said Martie de Villiers, Biosimilars Business Unit Manager, Organon ANZ.

The growing adoption of biosimilars has already delivered significant savings across Australia’s medicines system. Analysis of tumour necrosis factor (TNF) inhibitor biosimilar listings found cumulative PBS savings of $562.3 million between 2015 and 2025. Brenzys, the biosimilar to Pfizer’s Enbrel, delivered the largest savings at $341.5 million, representing a 23.7% reduction, while Hadlima, the biosimilar to AbbVie’s Humira, generated savings of $195.3 million, representing a 9.4% reduction. The greatest savings were achieved in rheumatoid arthritis, followed by ankylosing spondylitis and psoriatic arthritis.

The role of biosimilars is expected to become increasingly prominent following the Federal Government’s May Budget announcement of a consultation process exploring whether biosimilar medicines could become the default option for new prescriptions. The proposed reform is designed to accelerate uptake of cost-effective alternatives to biologic medicines and could generate up to $1.5 billion in savings over five years.

“Our partnership with Samsung Bioepis 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,” said Paul Asten, Business Manager for Customer, Trade and Partnerships, Organon ANZ.

While the industry’s ambition is for these savings to be redirected towards innovative medicines, the reality is that previous PBS savings have mostly been absorbed into broader government expenditure rather than reinvested into the medicines sector. This concern is particularly relevant given the absence of dedicated funding in the May Federal Budget to support implementation of the Health Technology Assessment (HTA) Review reforms and the potential for future savings generated through biosimilar uptake to follow a similar path.

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