Blog
RSS FeedPosted by Michael Wonder on 12 Sep 2017
FDA accepts Adello’s biosimilar biologics license application for a proposed filgrastim biosimilar
11 September 2017 - U.S.-based Adello Biologics today announced that U.S. FDA has accepted for review the company’s biologics license ...
Posted by Michael Wonder on 12 Sep 2017
Sandoz proposed biosimilar rituximab accepted for review by the FDA
12 September 2017 - Sandoz believes the comprehensive data package submitted to the FDA for review confirms that our biosimilar rituximab ...
Posted by Michael Wonder on 03 Sep 2017
Sanofi receives tentative FDA approval of Admelog (insulin lispro) 100 units/mL
1 September 2017 - Sanofi announced today that the U.S. FDA granted tentative approval for Admelog (insulin lispro injection) 100 ...
Posted by Michael Wonder on 31 Aug 2017
USFDA target action date for trastuzumab reset to 3 December 2017
30 August 2017 - The US FDA has notified our partner Mylan that they will extend the target action date for ...
Posted by Michael Wonder on 30 Aug 2017
Boehringer Ingelheim Pharmaceuticals receives FDA approval for Cyltezo (adalimumab-adbm), a biosimilar to Humira, for the treatment of multiple chronic inflammatory diseases
29 August 2017 - Cyltezo is the first biosimilar from Boehringer Ingelheim to be approved by the FDA, building on 35 ...
Posted by Michael Wonder on 16 Aug 2017
What’s harder than making copycat biotech drugs? Selling them
15 August 2017 - Payer pacts, wary patients vex the market for biosimilar drugs. ...
Posted by Michael Wonder on 31 Jul 2017
Celltrion and Teva announce U.S. FDA acceptance of biologics license application for proposed biosimilar to Herceptin (trastuzumab)
31 July 2017 - Celltrion and Teva Pharmaceuticals today announced that the U.S. FDA has accepted for review the biologics license ...
Posted by Michael Wonder on 31 Jul 2017
Amgen and Allergan submit biosimilar biologics license application for ABP 980 to US Food And Drug Administration
31 July 2017 - Filing for ABP 980, a biosimilar candidate to Herceptin (trastuzumab), supported by phase 3 data in ...
Posted by Michael Wonder on 24 Jul 2017
Merck announces U.S. launch of Renflexis (infliximab-abda), a biosimilar of remicade, for all eligible indications
24 July 2017 - Merck today announced the U.S. launch of Renflexis (infliximab-abda), a biosimilar of the originator biologic medicine ...
Posted 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 ...