45 documents

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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...
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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...
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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...
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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....
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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....
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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...
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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...
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19:29 , Oct 26, 2018 |  BC Week In Review  |  Clinical News

CHMP backs Takhzyro, Dengue vaccine, biosimilar Herceptin

EMA’s CHMP on Oct. 19 recommended several approvals, including hereditary angioedema (HAE) mAb Takhzyro lanadelumab, dengue vaccine Dengvaxia and Herceptin trastuzumab biosimilar Ogivri. CHMP backed Takhzyro from Shire plc (LSE:SHP; NASDAQ:SHPG) to prevent recurrent attacks...
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23:38 , Oct 19, 2018 |  BC Extra  |  Company News

CHMP backs Takhzyro, Dengue vaccine, biosimilar Herceptin

EMA’s CHMP recommended several approvals Friday, including hereditary angioedema (HAE) mAb Takhzyro lanadelumab, dengue vaccine Dengvaxia and Herceptin trastuzumab biosimilar Ogivri. CHMP backed Takhzyro from Shire plc (LSE:SHP; NASDAQ:SHPG) to prevent recurrent attacks of HAE....
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18:23 , Jun 8, 2018 |  BC Week In Review  |  Clinical News

FDA rebuffs third biosimilar Herceptin

Amgen Inc. (NASDAQ:AMGN) received a complete response letter from FDA for ABP 980. This marks the third CRL the agency has issued for a biosimilar of Herceptin trastuzumab. Amgen declined to disclose details of the...
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