UPDATE : Wednesday, December 12, 2018
Samsung Bioepis gets additional approval for its biosimilar
  • By Lee Hye-seon
  • Published 2017.09.21 12:03
  • Updated 2017.09.21 12:26
  • comments 0

Amid the controversy caused by MSD Korea’s alleged decision to cease promotional activities for biosimilar products made by Samsung Bioepis, the latter has won the domestic approval of Humira’s (compound: adalimumab) biosimilar.

The Ministry of Food and Drug Safety (MFDS)식약처 Wednesday said it approved Hadlima prefilled syringe inj. of Samsung Bioepis삼성바이오에피스. The company also made a similar announcement on the same day.

Among Humira’s indications, Hadlima has won the right to be applied to diseases such as rheumarthritis, psoriatic arthritis, psoriasis, colitis ulcerative, and juvenile idiopathic arthritis. Humira also has indications for Behçet enteritis, hidradenitis suppurativa, and uveitis.

Hadlima is the biosimilar of the world’s best-selling medicine Humira, and is also known as its clinical trial product name SB5. It got approval in Europe on Aug. 24 with the product name of Imraldi

But it appears difficult to release Hadlima immediately because the patent of the original medicine Humira is still valid. The patent for “human antibody to combine human TNFα” will expire on Jan. 4, 2019.

Besides, the patents for “methods of administering anti-TNFα antibodies” and “pharmaceutical anti-TNF-αantibody formulation” will expire on June 5, 2022, and on Aug. 15, 2023, respectively. Also, the patent for “multiple-variable dose regimen for treating TNFα-related disorders” will end on April 11, 2025.


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