Blog
RSS FeedPosted by Michael Wonder on 20 Jul 2017
Merck announces U.S. FDA grants tentative approval for Lusduna Nexvue (insulin glargine injection), a follow-on biologic basal insulin
20 July 2017 - Merck today announced that the U.S. FDA has granted tentative approval for Lusduna Nexvue™ (insulin glargine ...
Posted by Michael Wonder on 13 Jul 2017
Amgen and Allergan to discuss data supporting biologics license application for ABP 215, a biosimilar candidate to Avastin (bevacizumab)
13 July 2017 - First Amgen and Allergan oncology biosimilar candidate to be reviewed by U.S. FDA Advisory Committee ...
Posted by Michael Wonder on 30 Jun 2017
Celltrion and Teva announce U.S. FDA acceptance of biologics license application for proposed biosimilar to Rituxan (rituximab)
29 June 2017 - Celltrion and Teva Pharmaceutical Industries today announced that the U.S. FDA has accepted for review the biologics ...
Posted by Michael Wonder on 23 Jun 2017
Pfizer provides update on proposed epoetin alfa biosimilar
22 June 2017 - Pfizer today announced that it has received a complete response letter from the U.S. FDA regarding the ...
Posted by Michael Wonder on 12 Jun 2017
Supreme Court speeds copycat biologic drugs to market
12 June 2017 - The U.S. Supreme Court on Monday cut the time it will take for copycat versions of ...
Posted by Michael Wonder on 12 Jun 2017
Coherus Biosciences receives complete response letter from FDA for its biologics license application for CHS-1701 (pegfilgrastim biosimilar candidate)
12 June 2017 - Coherus BioSciences today announced that the U.S. FDA has issued a complete response letter for its ...
Posted by Michael Wonder on 08 Jun 2017
Biosimilar drugs offer promise for drug price savings, but risks remain
5 June 2017 - The issue of prescription drug prices continues to top the list of public concerns about health ...
Posted by Michael Wonder on 21 May 2017
ALPHAEON submits biologics license application for DWP-450 neuromodulator BLA submitted within three years of first patient enrolment
16 May 2017 - ALPHAEON today announced that its wholly-owned subsidiary Evolus, submitted a biologics license application for DWP-450, a Botulinum ...
Posted by Michael Wonder on 20 May 2017
Janssen files suit in U.S. to block sale of Samsung Bioepis' Remicade copy
18 May 2017 - A unit of healthcare conglomerate Johnson & Johnson filed a lawsuit to block a copy of ...
Posted by Michael Wonder on 08 May 2017
PDA/FDA Biosimilars Conference - 26-27 June 2017
3 May 2017 - The FDA and PDA are co-sponsoring a conference to identify best practices for global development and approval ...
Posted by Michael Wonder on 27 Apr 2017
U.S. top court grapples over making copycat biologics available sooner
26 April 2017 - U.S. Supreme Court justices on Wednesday struggled over whether to speed up the time it takes ...
Posted by Michael Wonder on 22 Apr 2017
FDA approves Samsung Bioepis' copy of J&J's Remicade: company
21 April 2017 - South Korea's Samsung Bioepis said on Saturday the U.S. FDA approved its copy of Johnson & ...
Posted by Michael Wonder on 19 Apr 2017
Improving access to cancer treatments: the role of biosimilars
18 April 2017 - Biologics play a key role in cancer treatment and are principal components of many therapeutic regimens. ...
Posted by Michael Wonder on 18 Mar 2017
Guide to recent biosimilar activity by FDA and in the Supreme Court
16 March 2017 - The US FDA recently completed a flurry of activity to help define the biosimilar pathway, including ...
Posted by Michael Wonder on 15 Mar 2017
First biosimilar monoclonal antibody in oncology granted EU approval: implications for the U.S. market
14 March 2017 - Recent developments in Europe may augur a new push for oncology biosimilars in the United States. ...