UPDATE : Saturday, February 22, 2020
FDA OKs Samsung Bioepis’ first oncology medicine
  • By Lee Han-soo
  • Published 2019.01.21 11:43
  • Updated 2019.01.21 11:43
  • comments 0

Samsung Bioepis said Monday that the U.S. Food and Drug Administration has approved Ontruzant, a biosimilar referencing Herceptin, across all eligible indications.

The treatment treats HER2-overexpressing breast cancer, metastatic breast cancer, metastatic gastric cancer and gastroesophageal junction adenocarcinoma in patients who have not received prior therapy for metastatic disease.

Its original, Herceptin, is one of the world’s most purchased medicines with an annual sale of $6.9 billion in 2015.

Ontruzant is Samsung Bioepis’ first oncology biosimilar to receive FDA approval. Merck, which is known as MSD in Korea, will be in charge of marketing and distributing the product in the U.S.

“For many cancer patients in the U.S., battling cancer has not only been a health issue, but a considerable financial burden brought on by cancer treatment,” said Pak Sang-jin, senior vice president and head of commercial division at Samsung Bioepis.

Biosimilars are intended to be lower cost, high-quality treatment options that have the potential to alleviate such burden and the company expects its trastuzumab biosimilar will do exactly that, he added.


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