News Release

November 14, 2022

ORGANON CANADA LAUNCHES ONTRUZANT®, A BIOSIMILAR OF THE REFERENCE BIOLOGIC HERCEPTIN*,PROVIDING PATIENTS IN CANADA WITH CERTAIN BREAST AND GASTRIC CANCERS WITH AN ADDITIONAL THERAPEUTIC OPTION AT A LOWER COST

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Kirkland, Quebec, November 14, 2022  – Organon (NYSE: OGN), a global women’s health company, today announced the availability and distribution of ONTRUZANT®, a biosimilar of Herceptin*, providing an additional treatment option for Canadian adults diagnosed with early breast cancer (EBC), metastatic breast cancer (MBC) and metastatic gastric cancer (MGC).1

“Particularly during Global Biosimilars Week, we recognize that many patients across Canada require more affordable treatment options,” said Michael Casia, president and managing director of Organon Canada. “With the availability of ONTRUZANT®, Organon Canada is committed to supporting patients through their treatment journey and will continue to be Here for Her Health.”

This announcement supports Organon Canada’s commitment to confronting the unmet health needs of women, through its vision of creating a healthier every day for every woman. It is estimated that one in eight women in Canada is expected to develop breast cancer, and breast cancer represents the second leading cause of death from cancer among women in the country.2

In addition, aside from breast cancer, ONTRUZANT® is also indicated for metastatic gastric cancer. In 2022, it is estimated that 4,100 Canadians will be diagnosed with stomach cancer, and 2,000 will die from it.3

“The inclusion of biosimilars as an additional treatment option for breast and gastric cancer can help increase the availability of more affordable medicines to Canadians, thus providing additional resources to reinvest in ongoing innovation across our healthcare system”, said Dr. Sandeep Sehdev, Medical Oncologist, Ottawa Hospital Cancer Centre.

With the company’s experience in biosimilars, the launch of ONTRUZANT® represents Organon Canada second Oncology product available for patients battling certain forms of cancers.

ONTRUZANT® was developed and manufactured by Organon’s collaborator Samsung Bioepis which also developed and manufactured its other biosimilars portfolio including recently launched AYBINTIO® as well as HADLIMA®, RENFLEXIS® and BRENZYS®.

About Organon

Organon is a global healthcare company formed to focus on improving the health of women throughout their lives. Organon has a portfolio of more than 60 medicines and products across a range of therapeutic areas. Led by the women’s 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 innovation and 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 10,000 employees with headquarters located in Jersey City, New Jersey.

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Forward-Looking Statement of Organon & Co., Jersey City, N.J., USA

Except for historical information herein, this news release includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including, but not limited to, statements about management’s expectations about Organon’s future financial performance and prospects. Forward-looking statements may be identified by words such as “expects,” “intends,” “anticipates,” “plans,” “believes,” “seeks,” “estimates,” “will” or words of similar meaning. These statements are based upon the current beliefs and expectations of the company’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.

Risks and uncertainties include, but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of the ongoing COVID-19 pandemic and emergence of variant strains; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances; new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict its future financial results and performance; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s filings with the Securities and Exchange Commission (SEC), including its registration statement on Form 10, available at the SEC’s Internet site (www.sec.gov).


References:  1. ONTRUZANT® Product Monograph. Organon Canada. January 28, 2022. https://www.organon.com/canada-en/ontruzant-pm_e. 2. Canadian Cancer Society. Breast Cancer Statistics. Available at https://cancer.ca/en/cancer-information/cancer-types/breast/statistics. Accessed on September 14, 2022. 3. Canadian Cancer Society. Stomach Cancer Statistics. Available at https://cancer.ca/en/cancer-information/cancer-types/stomach/statistics. Accessed on September 14, 2022.
4. Government of Quebec. Biosimilar Drugs. Available at https://www.quebec.ca/en/health/health-system-and-services/biosimilar-drugs/advantages-and-efficacy-of-biosimilar-drugs. Accessed on September 15, 2022.

TM/® N.V. Organon. Used under license.
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