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Samsung Bioepis Continues Global Market Expansion with Launch of HADLIMA™ in Australia and Canada in partnership with Merck & Co.
• Samsung Bioepis broadens its global reach by launching HADLIMA™ in Australia and in Canada, both in partnership with Merck & Co.
• Samsung Bioepis’ adalimumab is now available in three markets: Europe, Canada and Australia

INCHEON, Korea, March 29, 2021 - Samsung Bioepis Co., Ltd. today announced its expansion of its global footprint to Australia with the launch of HADLIMA™ i (adalimumab), a biosimilar referencing HUMIRA ii(adalimumab) for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult and paediatric Crohn’s disease, ulcerative colitis, hidradenitis suppurativa and plaque psoriasis.

With the launch in Australia, Samsung Bioepis’ adalimumab is now available in three markets: Europe, Canada, and Australia, underscoring the company’s continuous efforts to expand its reach in multiple markets across the world. It was first launched in Europe in October 2018 under the name IMRALDI™ in partnership with Biogen, followed by Canada in February 2021 in partnership with Merck & Co., Inc., Kenilworth, NJ, USA, known as MSD outside of the US and Canada.

“We are delighted by our partnership with MSD Australia to bring this important medicine to patients in Australia, followed by our recent launch in Canada,” said Albert Kim, Vice President of the Commercial Strategy Team at Samsung Bioepis. “It marks another important milestone for us and represents our commitment to bring high quality treatment to patients around the world.”

HADLIMA™ is Samsung Bioepis’ third anti-TNF biosimilar launched in Australia, following the launch of BRENZYS™ (etanercept) in December 2016 and RENFLEXIS™ (infliximab) in July 2017. HADLIMA™ will be available on the Pharmaceutical Benefits Scheme (PBS) from April 1, 2021.

In addition to Australia and Canada, Samsung Bioepis’ adalimumab has obtained the approval for marketing in Europe, Switzerland, the US and Korea.

Samsung Bioepis partnered with Merck & Co., Inc., Kenilworth, NJ, USA in 2013. Under terms of the agreement, Samsung Bioepis is responsible for preclinical and clinical development, process development, manufacturing, clinical trials and regulatory registration, while Merck & Co. is responsible for commercialization of the products approved in its partnered territories.

Since the establishment in 2012, Samsung Bioepis has rapidly grown its portfolio to a total of five biologic products in immunology and oncology, with more than 240,000 patients iii treated with the company’s immunology products in Europe alone. The company continues to improve access to medicines and currently has five biosimilar candidates in its pipeline ranging from hematology and ophthalmology.

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: and follow us on social media– Twitter, LinkedIn.

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i HADLIMA™ is a trademark of Merck, Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ USA, known as MSD outside the United States and Canada.
ii HUMIRA is a registered trademark of AbbVie Inc.
iii Biogen Q4 and Full Year 2020 Earnings Presentation. Available at [Last accessed March 2021]