03:01 , Sep 1, 2018 |  BioCentury  |  Politics, Policy & Law

A pathway to Biopharma 3.0

As market and social forces continue to tighten around the biopharmaceutical industry, drug companies need to start evolving toward a new business model that both capitalizes on the potential of new technologies and accommodates society’s...
21:26 , Jul 27, 2018 |  BioCentury  |  Regulation

Biosimilar barriers

A coming showdown over anticompetitive contracting practices, coupled with an impending wave of patent expirations, could result in a wave of biosimilar approvals and launches in the U.S. over the next year, according to biosimilars...
15:27 , Jul 27, 2018 |  BC Week In Review  |  Clinical News

FDA approves Pfizer Nivestym, second Neupogen biosimilar

FDA approved Nivestym filgrastim-aafi from Pfizer Inc. (NYSE:PFE), its biosimilar version of neutropenia drug Neupogen filgrastim from Amgen Inc. (NASDAQ:AMGN). The approval includes all indications on Neupogen's label. The July 20 approval followed July 18 remarks...
22:22 , Jul 20, 2018 |  BC Extra  |  Company News

FDA approves Pfizer's Neupogen biosimilar

FDA approved Nivestym filgrastim-aafi from Pfizer Inc. (NYSE:PFE), its biosimilar version of neutropenia drug Neupogen filgrastim from Amgen Inc. (NASDAQ:AMGN). The approval includes all indications on Neupogen's label. The approval comes two days after FDA Commissioner...
19:07 , Dec 15, 2017 |  BC Week In Review  |  Company News

Federal Appeals Court rules that Biosimilars Act preempts state law

In a ruling issued in the case of Amgen Inc. v. Sandoz Inc. concerning biosimilars, the U.S. Court of Appeals for the Federal Circuit (CAFC) held that the federal Biologics Price Competition and Innovation Act...
20:40 , Dec 14, 2017 |  BC Extra  |  Politics & Policy

Appeals court: Federal biosimilars act preempts state law

In a ruling issued in the case of Amgen Inc. v. Sandoz Inc. concerning biosimilars, the U.S. Court of Appeals for the Federal Circuit (CAFC) held that the federal Biologics Price Competition and Innovation Act...
23:21 , Nov 30, 2017 |  BC Week In Review  |  Company News

Amgen buys out Kyowa JV

In October, Amgen Inc. (NASDAQ:AMGN) and Kirin Holdings Co. Ltd. terminated their JV Kirin-Amgen, which now becomes a wholly-owned subsidiary of Amgen. Kirin is the parent company of Kyowa Hakko Kirin Co. Ltd. (Tokyo:4151). Kirin will...
03:19 , Nov 17, 2017 |  BC Week In Review  |  Company News

CAFC affirms Apotex biosimilars do not infringe Amgen patent

The U.S. Court of Appeals for the Federal Circuit (CAFC) affirmed a district court ruling that two biosimilars from Apotex Inc. (Toronto, Ontario) do not infringe a patent held by Amgen Inc. (NASDAQ:AMGN). Amgen sought...
23:16 , Nov 13, 2017 |  BC Extra  |  Company News

CAFC affirms Apotex biosimilars do not infringe Amgen patent

The U.S. Court of Appeals for the Federal Circuit affirmed a district court ruling that two biosimilars from Apotex Inc. (Toronto, Ontario) do not infringe a patent held by Amgen Inc. (NASDAQ:AMGN). Amgen sought a...
22:24 , Sep 15, 2017 |  BC Extra  |  Politics & Policy

U.S. government asserts biosimilars act preempts state law

On Monday, the U.S. government submitted an amicus brief to the U.S. Court of Appeals for the Federal Circuit (CAFC) in the case of Amgen Inc. v. Sandoz Inc. arguing that the federal Biologics Price...