Samsung Bioepis Announces Health Canada Approval of Citrate-Free High-Concentration of HUMIRA®¹ Biosimilar (adalimumab; SB5)

• With the approval, Samsung Bioepis has both low (40mg/0.8mL) and high (40 mg/0.4mL) concentration of adalimumab biosimilar approved in Canada
• Reaffirms its commitment to increasing accessibility by bringing more alternative therapeutic options that meet patients' needs

INCHEON, Korea, Jan. 03, 2023 (GLOBE NEWSWIRE) -- Samsung Bioepis Co., Ltd. today announced that Health Canada has approved HADLIMAtm (also known as SB5) - a citrate-free, high concentration (40 mg/0.4 ML) formulation of biosimilar referencing HUMIRA^® (adalimumab). HADLIMA is indicated for the treatment of rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis, ankylosing spondylitis (AS), psoriatic arthritis, adult Crohn's disease, ulcerative colitis, adult and adolescent hidradenitis suppurativa, plaque psoriasis, adult and pediatric uveitis.

"We are pleased to receive Health Canada approval of our high concentration adalimumab biosimilar, marking a key milestone for us now to have both a low and high concentration adalimumab biosimilar approved in Canada," said Byoungin Jung, Vice President and Regulatory Affairs Team Leader at Samsung Bioepis. "The latest approval reflects our continuous efforts to meet the needs of our patients and bring more treatment options available."

The Health Canada approval of the new formulation was based on the result of Phase 1 clinical trial comparing pharmacokinetic (PK), safety, and tolerability of the new SB5 formulation (40 mg/0.4 mL) with prior SB5 formulation (40 mg/0.8 mL) in healthy male subjects. The study demonstrated PK equivalence between new SB5 formulation and prior SB5 formulation in healthy subjects. Both formulations of SB5 were generally well tolerated with similar safety profiles.

HADLIMA was previously approved by Health Canada as a low-concentration (40mg/0.8mL) formulation in May 2018. In Canada, the low-concentration formulation was launched in February 2021 in partnership with Organon. The citrate-free, high-concentration HADLIMA will also be commercialized by Organon, later in 2023.

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 biologic 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.

¹ HUMIRA^® is a registered trademark of AbbVie