July 16, 2026 10:27 am EDT

This amended agreement deepens Organon and Samsung Bioepis’ collaboration to four biosimilars in Australia, expanding biosimilar access in Australia across multiple therapeutic areas.

SYDNEY, Australia and INCHEON, Korea – 16 July 2026 – Organon, a global healthcare company with deep expertise in biosimilars, and Samsung Bioepis Co., Ltd. have announced the expansion of their Development and Commercialisation Agreement, to commercialise a new biosimilar in Australia by Organon ANZ.

Under the terms of the agreement, Organon will obtain exclusive commercial rights to the product in Australia while Samsung Bioepis will maintain full development, manufacturing and regulatory responsibilities.

“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, Samsung Bioepis.

“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 continued.

“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.

According to an analysis that aimed to estimate the historical and future financial impact of biosimilars on Pharmaceutical Benefit Scheme (PBS) expenditure, biosimilars have already generated significant savings for Australia’s healthcare system, with $1.03 billion saved through the PBS from 2015 to 2022.[1] An additional $3.87 billion in savings could be generated between 2023 to 2027.¹

“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.

About Samsung Bioepis Co., Ltd.

Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realising healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world’s leading biopharmaceutical company. As a wholly owned subsidiary of Samsung Epis Holdings, Samsung Bioepis continues to advance a broad pipeline of biologic candidates across immunology, oncology, ophthalmology, haematology, nephrology, neurology, and endocrinology. For more information, please visit www.samsungbioepis.com and follow us on LinkedIn and X.

About Organon

Organon (NYSE: OGN) is a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day. With a portfolio of over 70 products across Women’s Health and General Medicines, which includes biosimilars, Organon focuses on addressing health needs that uniquely, disproportionately or differently affect women, while expanding access to essential treatments in over 140 markets. Head-quartered in Jersey City, New Jersey, Organon is committed to advancing access, affordability, and innovation in healthcare.

Cautionary Note Regarding Forward-Looking Statements

This press release includes “forward-looking statements” within the meaning of the safe harbor provisions of the United States’ Private Securities Litigation Reform Act of 1995, including, but not limited to, statements about Organon ANZ’s commercialization of a new biosimilar in Australia, the role of biosimilars in the healthcare system, and Organon ANZ’s ongoing commercial relationship with Samsung Bioepis. Forward-looking statements may be identified by words such as “could,” “will,” “aim,” “can,” and words of similar meaning. These statements are based upon the current beliefs and expectations of Organon’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate, or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Factors that could cause results to differ materially from those described in the forward-looking statements can be found in Organon’s filings with the U.S. Securities and Exchange Commission (“SEC”), including Organon’s most recent Annual Report on Form 10-K and other SEC filings, available at the SEC’s Internet site (www.sec.gov). Organon undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

© (2026) Organon group of companies.  All rights reserved. Organon and the Organon logo are trademarks of the Organon group of companies.

Organon ANZ, Level 5, 66 King St, Sydney, NSW 2000. AU-NON-110329. First issued July 2026. For more information, visit www.organon.com/australia or connect with us on LinkedIn at @OrganonANZ.

References

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[1] HTAnalysts. Biosimilars in Australia. A White Paper. Prepared on behalf of Organon Australia. December 2022.