18:14 , Feb 15, 2019 |  BC Week In Review  |  Company News

Samsung Bioepis partners with AffaMed, expands biosimilar development in China

Samsung Bioepis Co. Ltd. (Incheon, South Korea) partnered to develop four of its biosimilars with AffaMed Therapeutics (Shanghai, China). The partners will initially collaborate on clinical development, regulatory registration and commercialization Ontruzant, SB11, SB12 and...
00:38 , Jan 25, 2019 |  BC Week In Review  |  Clinical News

Samsung's Herceptin biosimilar gains U.S. approval

FDA approved a BLA for Ontruzant trastuzumab-dttb from Samsung Bioepis Co. Ltd. (Incheon, Korea), a biosimilar of Herceptin. The biosimilar is Samsung Bioepis' first approved in the U.S. to treat cancer. Ontruzant received approval for...
16:55 , Jan 22, 2019 |  BC Extra  |  Company News

Samsung's Herceptin biosimilar gains U.S. approval

FDA approved a BLA for Ontruzant trastuzumab-dttb from Samsung Bioepis Co. Ltd. (Incheon, Korea), a biosimilar of Herceptin. The biosimilar is Samsung Bioepis' first approved in the U.S. to treat cancer. Ontruzant received approval for...
01:03 , Jan 12, 2019 |  BioCentury  |  Finance

Warning: cash needed

  A near decade-long run of cheap money appears to be coming to a close, and most of the biotech sector isn’t well positioned for the new reality. BioCentury’s analysis shows that two-thirds of biotech...
20:44 , Dec 21, 2018 |  BC Week In Review  |  Clinical News

FDA approves Celltrion's Herceptin biosimilar

FDA approved a BLA for Herceptin biosimilar Herzuma trastuzumab-pkrb from Celltrion Inc. (KOSDAQ:068270) to treat HER2-positive breast cancer. In April, Celltrion received complete response letters from FDA for Herzuma and Truxima rituximab-abbs, its Rituxan biosimilar....
20:14 , Dec 21, 2018 |  BC Week In Review  |  Financial News

Shanghai Henlius up for Hong Kong IPO

Biosimilars company Shanghai Henlius Biotech Inc. (Shanghai, China) proposed on Dec. 14 to list on the Hong Kong stock exchange. Shanghai Henlius' lead compound is HLX01, a biosimilar of cancer and autoimmune drug MabThera rituximab...
00:06 , Dec 15, 2018 |  BC Extra  |  Financial News

Shanghai Henlius up for Hong Kong IPO

Biosimilars company Shanghai Henlius Biotech Inc. (Shanghai, China) proposed on Friday to list on the Hong Kong stock exchange. Shanghai Henlius' lead compound is HLX01, a biosimilar of cancer and autoimmune drug MabThera rituximab from...
23:39 , Dec 14, 2018 |  BC Extra  |  Company News

FDA approves Celltrion's Herceptin biosimilar

FDA approved a BLA for Herceptin biosimilar Herzuma trastuzumab-pkrb from Celltrion Inc. (KOSDAQ:068270) to treat HER2-positive breast cancer. In April, Celltrion received complete response letters from FDA for Herzuma and Truxima rituximab-abbs, its Rituxan biosimilar....
20:15 , Nov 9, 2018 |  BC Week In Review  |  Clinical News

FDA extends review of Samsung Bioepis' trastuzumab biosimilar

A Samsung Bioepis Co. Ltd. spokesperson told BioCentury that FDA extended by three months its review of a BLA for SB3, a biosimilar of cancer drug Herceptin trastuzumab from Roche (SIX:ROG; OTCQX:RHHBY) and its Genentech...
01:14 , Nov 9, 2018 |  BC Extra  |  Company News

FDA extends review of Samsung Bioepis' trastuzumab biosimilar

A Samsung Bioepis Co. Ltd. spokesperson told BioCentury that FDA extended by three months its review of a BLA for SB3, a biosimilar of cancer drug Herceptin trastuzumab from Roche (SIX:ROG; OTCQX:RHHBY) and its Genentech...