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  • Alvogen receives approval for its Humira biosimilar in KOR
  • by Lee, Hye-Kyung | translator Alice Kang | Oct 17, 2024 05:51am
Starts a 5-way race in Korea
3 items approved, including ¡®Simlandi pen¡¯ and ¡®Simlandi prefilled syringe inj.¡¯
 ¡ã AbbVie
A fifth Humira biosimilar has been approved in Korea.

On the 15th, the Ministry of Food and Drug Safety approved Alvogen Korea's Simlandi pen40mg/0.4mL (adalimumab, recombinant), Simandi Prefilled Syringe Inj 40mg/0.4mL and 80mg/0.8mL..

Simlandi is imported and manufactured on consignment by Alvotech, a subsidiary of Alvogen Korea.

It is the fourth biosimilar to be approved in Korea after Samsung Bioepis, Celltrion, and LG Chem, with more than 10 biosimilars approved globally following the patent expiry of the original, AbbVie's Humira.

Simlandi is indicated for rheumatoid arthritis, psoriatic arthritis, ankylosing spondyloarthritis, adult Crohn's disease, psoriasis, ulcerative colitis, Behçet's ente
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