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CompilationTom Lee
Samsung Bioepis and Organon announced that the U.
S.
Food and Drug Administration (FDA) has accepted for review a supplemental Biologics License Application (sBLA) for the high-dose 100 mg/mL formulation of Humira biosimilar SB5 (adalimumab-bwwd).
)
.
SB5 (adalimumab-bwwd) developed by Samsung Bioepis is a biosimilar made with reference to AbbVie's flagship product Humira (adalimumab)
.
Previously, a low-dose 50 mg/mL SB5 formulation was approved by the U.
It is worth noting that Hadlima is also the third anti-TNF biosimilar approved by Samsung Bioepis in the United States, and also the fourth biosimilar approved by the company 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 resubmitted its sBLA application for citrate-free, high-concentration 100 mg/mL adalimumab SB5 in October 2021, and the evidence submitted includes evidence based on a randomized, single-blind, two-arm, parallel-group, single-dose study Clinical data from two doses of SB5 formulations (100 mg/mL vs.
50 mg/mL) compared pharmacokinetics, safety, and tolerability and immunogenicity in healthy volunteers
.
Following future approvals, SB5 will be commercialized by Ogallon in the U.
The patent protection of Humira in the US market will expire in 2023.
As its patent protection in Europe and the United States also faces the dilemma of expiring, Humira is about to face fierce competition from biosimilars around the world
.
In China, due to the high market price of Humira, it has not yet entered the national medical insurance drug list
Reference source: FDA Accepts Samsung Bioepis' and Organon's sBLA for their Citrate-Free, High-Concentration HUMIRA® (Adalimumab) Biosimilar Candidate
