Wednesday , June 16 2021

Samsung Bioepis' boarstkanker biosimilar wins FDA approval



[THE INVESTOR] Samsung Bioepis & # 39; Unbreakable, a breast cancer treatment biosimilar referencing Roche & # 39; s Herceptin, won an American Food and Drug Administration petition on January 19, extending the Herceptin list to & # 39; an American mark for three.

Unscrupulous is the third FDA-compliant biosimilar of Switzerland's Roche's blockbuster breast cancer anti-code. The FDA approval is prior to Mylan's release in December 2017, and Cuerdrion's Herzuma in December 2018.

The three companies' biosimilars are expected to set up the US biopharmaceutical market in June, when they expire patients related to Herceptin. Herceptin is one of & # 39; a successful anti-idiotic drug from & # 39; e world. Since 1998, Herceptin has received Roche's most-selling monoclonal anti-kody, which is worth an annual sales of over $ 2.6 billion in US and $ 7 billion worldwide.

Ontruzant has been sold in the United Kingdom since March 2018, after winning ## in November 2017 the European Medicine Acquisition. Pfizer's Trazimera, Cuerdrion's Herzuma, Amgen, and Kanjinti's Allergan partner are also approved by the EEA.

In & # 39; a US is unzipped by Merck Sharp & Dohme, the same company that Samsung Bioepis & # 39; sells the other biosimilar in US, Renflexis. Available in US since July 2017, Renflexis is a tumor necrosis factor blocker that is used for Crohn's Disease, Rheumatoid Arthritis among others.

Samsung Bioepis is a community center of Samsung BioLogics and Biogen. Previously, attention was paid to checking irregularities at the time of its listing. Samsung BioLogics stock transactions were temporarily closed for a month before it was normalized in December.

By Lim Jeong-yeo / The Korea Herald ([email protected])


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