BC Extra | Jan 25, 2020
Company News

Pfizer seeking to dent market share with trio of discounted biosimilars

Pfizer is hoping that discounts of 22-24% from reference drugs’ wholesale acquisition costs (WACs) will help it gain market share for three new or soon-to-be launched biosimilars, each of which will compete with at least...
BioCentury | Dec 7, 2019
Product Development

U.S. biosimilars glass--half full or half empty?

Ten years after the U.S. created a pathway for biosimilars--and four and a half years after the first FDA approval--a few manufacturers have demonstrated that they can overcome the technical, regulatory and commercial barriers to...
BC Extra | Jul 19, 2019
Company News

July 19 Company Quick Takes: First biosimilars of Avastin, Herceptin launched; plus Gilenya, Celltrion-Nan Fung and Celgene

Amgen, Allergan launch pair of biosimilars  Amgen Inc. (NASDAQ:AMGN) and Allergan plc (NYSE:AGN) launched Mvasi bevacizumab-awwb and Kanjinti trastuzumab-anns in the U.S.; they are the first biosimilars of Avastin bevacizumab and Herceptin trastuzumab available in...
BC Week In Review | Dec 21, 2018
Clinical News

CHMP backs Besremi for polycythemia vera, two Shionogi drugs

EMA's CHMP recommended a basket of approvals and label extensions on Dec. 14, including Orphan Drug Besremi ropeginterferon alfa-2b to treat polycythemia vera and a pair of treatments from Shionogi & Co. Ltd. (Tokyo:4507). The...
BC Extra | Dec 14, 2018
Company News

CHMP backs Besremi for polycythemia vera, two Shionogi drugs

EMA's CHMP recommended a basket of approvals and label extensions on Friday, including Orphan Drug Besremi ropeginterferon alfa-2b to treat polycythemia vera and a pair of treatments from Shionogi & Co. Ltd. (Tokyo:4507). The agency...
BioCentury | Jul 27, 2018
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...
BioCentury | Jul 13, 2018
Strategy

Roche’s partnering priority

As James Sabry gets set to lead partnering for all of Roche pharma, his first order of business might be to build out the company’s late-stage pipeline ahead of an impending patent cliff that puts...
BioCentury | Apr 6, 2018
Finance

Fundamentally driven

Continued struggles by the mega-cap bellwethers and the resurgence of volatility in global equity markets were the major themes of 1Q18, whipsawing biotech stocks throughout the quarter but leaving index values little changed on the...
BC Week In Review | Jan 19, 2018
Clinical News

EC approves Amgen's biosimilar Avastin

Amgen Inc. (NASDAQ:AMGN) and Allergan plc (NYSE:AGN) said the European Commission approved Mvasi (ABP 215), a biosimilar of Avastin bevacizumab. The approval includes all cancer types on Avastin's EU label -- non-small cell lung cancer...
BC Extra | Jan 18, 2018
Company News

EC approves Amgen's biosimilar Avastin

Amgen Inc. (NASDAQ:AMGN) and Allergan plc (NYSE:AGN) said the European Commission approved Mvasi (ABP 215), a biosimilar of Avastin bevacizumab. The approval includes all cancer types on Avastin's EU label -- non-small cell lung cancer...
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