Blog
RSS FeedPosted by Michael Wonder on 21 May 2019
FDA replaces withdrawn biosimilar guidance with new one on quality-related considerations
21 May 2019 - A week after finalizing guidance on developing interchangeable biosimilars, the US FDA has drafted guidance for ...
Posted by Michael Wonder on 10 May 2019
Statement from Acting FDA Commissioner on policy advancements to help bring interchangeable biosimilars to market
10 May 2019 - The U.S. FDA plays an important role in helping to address the high cost of medicines ...
Posted by Michael Wonder on 28 Apr 2019
FDA approves Samsung Bioepis' etanercept biosimilar, Eticovo
26 April 2019 - The FDA has approved Samsung Bioepis’ etanercept biosimilar, SB4, as Eticovo (etanercept-ykro). ...
Posted by Michael Wonder on 14 Apr 2019
Biopharma CEOs explain problems with biosimilars to Congress
12 April 2019 - Following their Senate Finance Committee hearing in February, all seven biopharmaceutical CEOs have now offered hundreds ...
Posted by Michael Wonder on 09 Apr 2019
Biosimilars are a distraction
8 April 2019 - Biopharmaceutical products (also known as biologics) are among the most expensive pharmaceutical products on the market, and ...
Posted by Michael Wonder on 03 Apr 2019
Sandoz resubmits biosimilar pegfilgrastim application to US FDA
2 April 2019 - Sandoz pursues US approval for biosimilar pegfilgrastim, a long-acting version of supportive oncology medicine filgrastim. ...
Posted by Michael Wonder on 21 Mar 2019
Promoting biosimilars up to health plans, manufacturers, doctors, Gottlieb says
21 March 2019 - As he wraps up his final weeks as commissioner of the FDA, Scott Gottlieb, MD, talked about ...
Posted by Michael Wonder on 21 Mar 2019
AbbVie is sued for using Humira patent deals to block competition in the U.S.
20 March 2019 - In a novel step, a New York union accused AbbVie and seven other drug makers of ...
Posted by Michael Wonder on 20 Mar 2019
Biosimilar groups offer proposals to help US better mirror EU successes
19 March 2019 - With 18 biosimilars approved in the US and just seven on the market, two biosimilars groups ...
Posted by Michael Wonder on 20 Mar 2019
Biosimilar approval and adoption in the U.S. needs to be expedited
20 March 2019 - Generic versions of brand-name small-molecule drugs saved Americans more than $1 trillion between 1999 and 2010. ...
Posted by Michael Wonder on 19 Mar 2019
Biosimilars Forum and Medicines for Europe call for changes to the US biosimilars market
19 March 2019 - The Biosimilars Forum and Medicines for Europe today released a joint white paper that discusses how Europe ...
Posted by Michael Wonder on 07 Mar 2019
Statement from FDA Commissioner on FDA’s steps on naming of biological medicines to balance competition and safety for patients receiving these products
7 March 2019 - We’re at a critical point for the future of biosimilars in the U.S. Millions of American ...
Posted by Michael Wonder on 07 Feb 2019
What is a biosimilar, exactly?
5 February 2019 - They’re meant to save money for the health care system, carve into pharma’s profits, and finally ...
Posted by Michael Wonder on 19 Jan 2019
Samsung Bioepis biosimilar to Roche's Herceptin wins FDA nod
19 January 2019 - The U.S. FDA said on Friday it had approved a biosimilar to Roche’s blockbuster breast cancer ...
Posted by Michael Wonder on 15 Jan 2019
How a 'regulatory dead zone' may be holding up copycat insulin
14 January 2019 - The insulin market has increasingly attracted scrutiny from politicians, regulators and patient groups, as prices ramp ...