FDA Accepts Samsung Bioepis’ and Organon’s sBLA for their Citrate-Free, High-Concentration HUMIRA® (Adalimumab) Biosimilar Candidate

INCHEON, Korea & JERSEY CITY, NJ, USA I January 5, 2022 I Samsung Bioepis Co., Ltd. and Organon & Co. (NYSE: OGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for a citrate-free, high-concentration (100 mg/mL) formulation of SB5 (adalimumab-bwwd), a biosimilar candidate referencing HUMIRA® (adalimumab).1 SB5 was previously approved by the FDA under the brand name HADLIMA™ as a low-concentration (50 mg/mL) formulation in July 2019. The low concentration and high concentration forms of the reference product are both marketed in the United States (U.S.) today.

The sBLA for citrate-free, high-concentration adalimumab was submitted by Samsung Bioepis in October 2021 and was based on clinical data from a randomized, single-blind, two-arm, parallel group, single-dose study to compare the pharmacokinetics, safety, tolerability, and immunogenicity of two formulations of SB5 (100 mg/mL vs 50 mg/mL) in healthy volunteers.

SB5 will be commercialized in the U.S. by Organon. It is expected to launch in the U.S. on or after July 1, 2023, in accordance with a licensing agreement with AbbVie Inc.

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.

About Organon

Organon is a global healthcare company formed through a spin-off from Merck, (NYSE: MRK) known as MSD outside of the United States and Canada, to focus on improving the health of women throughout their lives. Here for her health, Organon has a portfolio of more than 60 medicines and products across a range of therapeutic areas. Led by the reproductive 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 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 9,000 employees with headquarters located in Jersey City, New Jersey.

For more information, visit http://www.organon.com and connect with us on LinkedIn and Instagram.

Endnotes

1. HUMIRA® is a registered trademark of AbbVie Inc.

SOURCE: Organon

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