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Samsung Bioepis gets nod for sale of biosimilar drug in Europe
firstwordpharma
March 06, 2019
Samsung Bioepis has won European approval of a 420-mg dosage of Ontruzant, a biosimilar of Roche's Herceptin, The Korea Herald reported Tuesday.
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Samsung Bioepis forms new alliance to expand in China
pharmaceutical-technology
February 13, 2019
Samsung Bioepis has signed a licensing deal with healthcare-focused private equity firm C-Bridge Capital to accelerate expansion in mainland China....
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Samsung Bioepis secures FDA approval for cancer drug Ontruzant
pharmaceutical-technology
January 22, 2019
The US Food and Drug Administration (FDA) has granted approval for Samsung Bioepis to use Ontruzant (trastuzumab-dttb) to treat a range of cancers.....
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Samsung Bioepis to Initiate Phase 1 Clinical Trial of SB26
americanpharmaceuticalreview
August 14, 2018
Samsung Bioepis will soon begin a Phase 1 study to evaluate SB26 in healthy volunteers. SB26, also known as TAK-671, is an ulinastatin-Fc (UTI-Fc) fusion protein intended to treat severe acute pancreatitis. Non-clinical GLP safety studies performed in mon
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Biogen, Samsung Bioepis and Abbvie settle patent dispute
pharmatimes
July 18, 2018
Biogen and Samsung Bioepis have laid to rest a long-running patent wrangle with AbbVie regarding a biosimilar form of the latter’s blockbuster Humira.
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Samsung wins first CHMP backing for a Herceptin biosim, imperiling $2B in Roche sales
fiercepharma
September 18, 2017
As challengers to Roche’s cancer blockbusters advance in the U.S. and around the world, Samsung Bioepis has taken a big step toward approval for a Herceptin biosim in Europe.
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Samsung-Takeda R&D pact, GSK-Alibaba vaccine union, Gland’s renewed M&A deal
fiercepharma
August 28, 2017
With a newly formed drug co-development deal, Samsung Bioepis is finally moving into novel drug R&D.
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Samsung Bioepis, Takeda Sign Agreement to Co-Develop Multiple Novel Biologic Therapies
americanpharmaceuticalreview
August 22, 2017
Samsung Bioepis has entered into a strategic collaboration agreement with Takeda to jointly fund and co-develop multiple novel biologic therapies in unmet disease areas.