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...
00:23 , Jan 12, 2019 |  BioCentury  |  Finance

We all fall down

After an exuberant third quarter that put biotech indexes near their 2015 highs, all market cap tiers fell in 4Q18, eliminating the first nine month’s gains and losing $291.2 billion in aggregate value. Median losses...
02:49 , Jan 5, 2019 |  BioCentury  |  Finance

Ready to launch

  The proposed $74 billion takeout of Celgene Corp. by Bristol-Myers Squibb Co. will not shift buysider attention away from upcoming and maturing drug launches heading into 2019, with plenty to track following a record...
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....
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....
18:24 , Nov 30, 2018 |  BC Week In Review  |  Clinical News

FDA approves first biosimilar for NHL

FDA approved a resubmitted BLA for Truxima rituximab-abbs from Celltrion Inc. (KRX:068270) and Teva Pharmaceutical Industries Ltd. (NYSE:TEVA; Tel Aviv:TEVA). The agency said Truxima is the first biosimilar approved in the U.S. to treat non-Hodgkin...
21:41 , Nov 28, 2018 |  BC Extra  |  Company News

FDA approves first biosimilar for NHL

FDA approved a resubmitted BLA for Truxima rituximab-abbs from Celltrion Inc. (KRX:068270) and Teva Pharmaceutical Industries Ltd. (NYSE:TEVA; Tel Aviv:TEVA). The agency said Truxima is the first biosimilar approved in the U.S. to treat non-Hodgkin...
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...