Blog
RSS FeedPosted by Michael Wonder on 23 Apr 2018
Pfizer provides update on proposed trastuzumab biosimilar
23 April 2018 - Pfizer today announced that it received a complete response letter from the United States FDA in response ...
Posted by Michael Wonder on 18 Apr 2018
FDA official insists U.S. is catching up to Europe on biosimilar regulations, approvals
17 April 2018 - The FDA lags behind its European counterpart when it comes to approving biosimilars — but a ...
Posted by Michael Wonder on 07 Apr 2018
FDA rejects Teva/Celltrion biosimilars
6 April 2018 - Teva and Celltrion’s attempt to muscle in on the multi-billion dollar US cancer and inflammatory disease ...
Posted by Michael Wonder on 03 Apr 2018
FDA charts path forward for biosimilars — but drug makers aren’t all on board
30 March 2018 - In his recent public appearances, FDA Commissioner Scott Gottlieb has sounded a repeating note: drug prices ...
Posted by Michael Wonder on 28 Mar 2018
To make copycat drugs more competitive, the FDA is taking a harder look at the originals
28 March 2018 - The FDA wants to improve branded drugs to help bolster the biosimilars market. ...
Posted by Michael Wonder on 07 Mar 2018
‘Rigged’ system blocks use of lower cost drugs, FDA Chief says
7 March 2018 - FDA has approved nine biosimilars, only three for sale in U.S. ...
Posted by Michael Wonder on 01 Mar 2018
Friction in the path to use of biosimilar drugs
1 March 2018 - Enactment of the Biologics Price Competition and Innovation Act in 2010 raised expectations that new competition would ...
Posted by Michael Wonder on 16 Jan 2018
Sandoz regulatory submission for proposed biosimilar adalimumab accepted by FDA
16 January 2018 - The comprehensive data package provided is expected to demonstrate that Sandoz proposed biosimilar adalimumab matches the reference ...
Posted by Michael Wonder on 21 Dec 2017
Samsung Bioepis’ SB3 trastuzumab biosimilar candidate accepted for review by the US FDA
20 December 2017 - Samsung Bioepis today announced that the US FDA has accepted for review the company’s biologics license application ...
Posted by Michael Wonder on 14 Dec 2017
FDA approves new Pfizer biosimilar
13 December 2017 - Pfizer-developed biosimilar medicine Ixifi (infliximab-qbtx) receives FDA approval for all eligible indications. ...
Posted by Michael Wonder on 11 Dec 2017
FDA approves Admelog, the first short-acting "follow-on" insulin product to treat diabetes
11 December 2017 - The U.S. FDA today approved Admelog (insulin lispro injection), a short-acting insulin indicated to improve control ...
Posted by Michael Wonder on 02 Dec 2017
FDA approves first biosimilar for the treatment of certain breast and stomach cancers
1 December 2017 - The U.S. FDA today approved Ogivri (trastuzumab-dkst) as a biosimilar to Herceptin (trastuzumab) for the treatment ...
Posted by Michael Wonder on 21 Nov 2017
Roche sues Pfizer to block biosimilar of cancer drug Herceptin
21 November 2017 - Company seeks to protect drug that earned $2.5 billion. ...
Posted by Michael Wonder on 19 Nov 2017
FDA begins adding suffixes to newly approved biologics' names
17 November 2017 - The US FDA this week began adding four-letter meaningless suffixes at the end of newly approved ...
Posted by Michael Wonder on 14 Nov 2017
The Supreme Court ruling in Sandoz v Amgen
13 November 2017 - A victory for follow-on biologics. ...