36 documents

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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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20:53 , Jun 1, 2018 |  BC Extra  |  Company News

FDA rebuffs third biosimilar Herceptin

Amgen Inc. (NASDAQ:AMGN) said Friday it 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...
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19:31 , Apr 27, 2018 |  BC Week In Review  |  Clinical News

Pfizer receives CRL for Herceptin biosimilar

Pfizer Inc. (NYSE:PFE) received a complete response letter from FDA for a BLA for PF-05280014, the company’s biosimilar of Herceptin trastuzumab. Pfizer said FDA requested additional technical information unrelated to safety or clinical data, but...
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16:45 , Apr 23, 2018 |  BC Extra  |  Company News

Pfizer receives CRL for Herceptin biosimilar

Pfizer Inc. (NYSE:PFE) received a complete response letter from FDA for a BLA for PF-05280014, the company’s biosimilar of Herceptin trastuzumab. Pfizer said FDA requested additional technical information unrelated to safety or clinical data, but...
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17:09 , Apr 6, 2018 |  BC Week In Review  |  Clinical News

FDA issues CRLs for Celltrion biosimilars

Celltrion Inc. (KOSDAQ:068270) received complete response letters from FDA for BLAs for Herzuma biosimilar trastuzumab (CT-P6) and Truxima biosimilar rituximab (CT-P10). Celltrion told BioCentury the letters are directly related to FDA's January warning letter describing GMP...
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23:21 , Apr 5, 2018 |  BC Extra  |  Company News

FDA issues CRLs for Celltrion biosimilars

Celltrion Inc. (KOSDAQ:068270) received complete response letters from FDA for BLAs for Herzuma biosimilar trastuzumab (CT-P6) and Truxima biosimilar rituximab (CT-P10). Celltrion told BioCentury the letters are directly related to FDA's January warning letter describing GMP...
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17:47 , Mar 30, 2018 |  BC Week In Review  |  Clinical News

Biosimilars, Clovis' Rubraca among CHMP recommendations

EMA's CHMP recommended approval of a basket of therapies including cancer drug Rubraca rucaparib from Clovis Oncology Inc. (NASDAQ:CLVS), two biosimilars and HIV therapy Juluca dolutegravir/rilpivirine from ViiV Healthcare Ltd. (Brentford, U.K.). CHMP backed Rubraca's conditional...
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16:11 , Mar 16, 2018 |  BC Week In Review  |  Company News

Merck launches Ontruzant in U.K.

Merck & Co. Inc. (NYSE:MRK) launched Ontruzant (SB3) in the U.K. The therapy is a biosimilar of cancer drug Herceptin trastuzumab from Roche (SIX:ROG; OTCQX:RHHBY) and its Genentech Inc. unit. Ontruzant is the first trastuzumab...
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19:58 , Feb 16, 2018 |  BC Week In Review  |  Clinical News

EC approves Celltrion's Herceptin biosimilar

Celltrion Inc. (KOSDAQ:068270) said the European Commission approved Herzuma, a biosimilar of cancer drug Herceptin trastuzumab from Roche (SIX:ROG; OTCQX:RHHBY) and its Genentech Inc. unit. The biosimilar is indicated to treat HER2-positive early breast cancer,...
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00:13 , Dec 22, 2017 |  BC Week In Review  |  Clinical News

EMA's CHMP recommends Celltrion's trastuzumab biosimilar

Celltrion Inc. (KOSDAQ:068270) received a positive recommendation from EMA's CHMP for Herzuma, a biosimilar of cancer drug Herceptin trastuzumab from Roche (SIX:ROG; OTCQX:RHHBY) and its Genentech Inc. unit. The committee recommended approval to treat HER2-positive...
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