Samsung Bioepis Announces Health Canada Approval Of 150mg Single-Use Vial And 440mg Multi-Dose Vial Of ONTRUZANT (SB3), Trastuzumab Biosimilar For The Treatment Of Adults With Early Breast Cancer, Metastatic Breast Cancer, And Metastatic Gastric Cancer

• 150mg and 440mg vial of ONTRUZANT® are now approved in Canada
• ONTRUZANT® becomes Samsung Bioepis’ fifth biosimilar to be approved in Canada in just six years

Incheon (GLOBE NEWSWIRE) - Samsung Bioepis Co. Ltd. today announced that Health Canada has approved ONTRUZANT® (also known as SB3), a biosimilar referencing Herceptin®ⁱ (Trastuzumab), for the treatment of adults with Early Breast Cancer (EBC), Metastatic Breast Cancer (MBC) and metastatic gastric cancer (MGC).

“Breast cancer is both the most common cancer and second leading cause of death from cancer among Canadian women. As a leading biosimilar company, we are very proud to be granted an approval of our ONTRUZANT bringing an alternative treatment option for patients,” said Byoungin Jung, Vice President and Regulatory Affairs Team Leader at Samsung Bioepis. “We have strong belief that ONTRUZANT will contribute in expanding patient access in Canada. Samsung Bioepis will continue our advancement in biosimilar pipelines so that cancer patients and healthcare system in Canada will benefit from biosimilars.”

Breast cancer is the most common cancer in Canada with 1 in 8 women to be diagnosed with breast cancer in their life time. Meaning, average of 76 Canadian women will be diagnosed with breast cancer every day.ⁱⁱ

ONTRUZANT® is Samsung Bioepis’ fifth biosimilar approved for the use in Canada following BRENZYS® (etanercept) in August 2016, RENFLEXIS® (infliximab) in December 2017, HADLIMA® (adalimumab) in May 2018, AYBINTIO® (bevacizumab) in November 2021. ONTRUZANT® will be commercialized in Canada by Organon.

The Health Canada approval was based on a comprehensive data package and totality of evidence which included analytical, pharmacokinetic (PK) and clinical data, as well as pharmacology and toxicology data. The data proved that ONTRUZANT® and reference trastuzumab are highly similar with no clinically meaningful difference.

About Samsung Bioepis Co., Ltd.
Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing 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. Samsung Bioepis continues to advance a broad pipeline of biosimilar candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, endocrinology and gastroenterology. For more information, please visit: www.samsungbioepis.com and follow us on social media – Twitter, LinkedIn.

ⁱ HERCEPTIN® is a registered trademark of Genentech Inc.

ⁱⁱ Canadian Cancer Society. Breast Cancer Statistics. Available at: https://cancer.ca/en/cancer-information/cancer-types/breast/statistics. Accessed in January 2022

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