BC Week In Review | Nov 16, 2018
Clinical News

Pfizer launches U.S.’s first biosimilar epoetin

Pfizer Inc. (NYSE:PFE) launched the first biosimilar of anemia drug epoetin alfa in the U.S., priced at a 33.5% discount to the lowest priced reference product. Amgen Inc. (NASDAQ:AMGN) markets reference drug Epogen and Johnson...
BC Extra | Nov 15, 2018
Company News

Pfizer launches U.S.’s first biosimilar epoetin

Pfizer Inc. (NYSE:PFE) launched the first biosimilar of anemia drug epoetin alfa in the U.S., priced at a 33.5% discount to the lowest priced reference product. Amgen Inc. (NASDAQ:AMGN) markets reference drug Epogen and Johnson...
BioCentury | Jun 30, 2018
Finance

Hidden in the rough

Judicious stock picking was especially important in the second quarter, as 57% of global biotech stocks saw their equity values decline. Volatility continued to roil global markets during the period and additional uncertainty looms with...
BC Week In Review | May 18, 2018
Clinical News

FDA approves Pfizer's Retacrit, first epoetin alfa biosimilar in U.S.

FDA approved Retacrit epoetin alfa-epbx from Pfizer Inc. (NYSE:PFE), a biosimilar of anemia drugs Epogen from Amgen Inc. (NASDAQ:AMGN) and Procrit from the Janssen Biotech Inc. unit of Johnson & Johnson (NYSE:JNJ). FDA said it...
BC Extra | May 15, 2018
Company News

FDA approves Pfizer's Retacrit, first epoetin alfa biosimilar in U.S.

FDA approved Retacrit epoetin alfa-epbx from Pfizer Inc. (NYSE:PFE), a biosimilar of anemia drugs Epogen from Amgen Inc. (NASDAQ:AMGN) and Procrit from the Janssen Biotech Inc. unit of Johnson & Johnson (NYSE:JNJ). FDA said it...
BC Extra | Jun 23, 2017
Company News

Pfizer gets another CRL for biosimilar Retacrit

Pfizer Inc. (NYSE:PFE) said it received a second complete response letter from FDA for a BLA for Retacrit epoetin alfa. The candidate is a biosimilar of anemia drugs Epogen from Amgen Inc. (NASDAQ:AMGN) and Procrit...
BC Week In Review | May 26, 2017
Clinical News

ODAC backs Pfizer biosimilar Retacrit

FDA's Oncologic Drugs Advisory Committee voted 14-1 in favor of approval of Retacrit epoetin alfa from Pfizer Inc. (NYSE:PFE). The candidate is a biosimilar of anemia drugs Epogen from Amgen Inc. (NASDAQ:AMGN) and Procrit from...
BC Extra | May 25, 2017
Company News

FDA panel backs Pfizer biosimilar Retacrit

FDA's Oncologic Drugs Advisory Committee voted 14-1 in favor of approval of Retacrit epoetin alfa from Pfizer Inc. (NYSE:PFE). The candidate is a biosimilar of anemia drugs Epogen from Amgen Inc. (NASDAQ:AMGN) and Procrit from...
BC Extra | May 23, 2017
Company News

Reviewers find Retacrit "highly similar" to reference products

In briefing documents released ahead of FDA's planned May 25 meeting of its Oncologic Drugs Advisory Committee, reviewers said the "totality of the evidence" suggests Retacrit epoetin alfa from Pfizer Inc. (NYSE:PFE) is "highly similar"...
BC Week In Review | Apr 21, 2017
Clinical News

Retacrit regulatory update

FDA's Oncologic Drugs Advisory Committee will meet on May 25 to discuss a BLA from Pfizer’s Hospira Inc. unit for Retacrit epoetin alfa, a proposed biosimilar of anemia drugs Epogen epoetin alfa from Amgen Inc....
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