FDA Accepts Samsung Bioepis and Organon’s sBLA for High-Concentration HUMIRA® Biosimilar SB5

Compiled by Tom Li

Recently, Samsung Bioepis and Organon announced that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for SB5 (adalimumab-bwwd), a high-dose 100mg/mL formulation of the Humira biosimilar.

SB5 (adalimumab-bwwd), developed by Samsung Bioepis, is a biosimilar referencing AbbVie's flagship product Humira (adalimumab). Previously, the low-dose 50mg/mL formulation of SB5 was approved by the U.S. FDA in July 2019 under the brand name Hadlima. Hadlima can be used to treat various autoimmune diseases, including rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), adult Crohn's disease (CD), ulcerative colitis (UC), and plaque psoriasis.

Notably, Hadlima is the third anti-TNF biosimilar from Samsung Bioepis to be approved in the United States, and also the company's fourth biosimilar to gain approval in the U.S. market. The other three are Renflexis (infliximab), approved in April 2017, Ontruzant (trastuzumab), approved in January 2019, and Eticovo (etanercept), approved in April 2019.

Samsung Bioepis Re-submitted the sBLA Application for Citrate-free, High-concentration 100mg/mL Adalimumab SB5 in October 2021. The submission included clinical data based on a randomized, single-blind, two-arm, parallel-group, single-dose study comparing the pharmacokinetics, safety, tolerability, and immunogenicity of two SB5 formulations (100mg/mL vs. 50mg/mL) in healthy volunteers. Upon future approval, SB5 will be commercialized in the U.S. market by Organon.

Humira's patent protection in the U.S. market will expire in 2023. As its patent protection in Europe and the U.S. also faces expiration, Humira is about to encounter fierce competition from biosimilars worldwide. In China, due to Humira's high market price, it has not yet been included in the National Reimbursement Drug List. According to the previous settlement and licensing agreement reached with AbbVie, it is expected that after SB5 successfully gains approval, the drug will hopefully be launched in the U.S. market on or after July 1, 2023.

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