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RSS FeedPosted by Michael Wonder on 22 Oct 2017
Will the FDA add suffixes to approved biologics' names?
20 October 2017 - Back in January, the US FDA finalised guidance on how biosimilars and their biologic reference products' ...
Posted by Michael Wonder on 10 Oct 2017
US FDA issues complete response letter for proposed biosimilar pegfilgrastim
10 October 2017 - The U.S. FDA has issued a complete response letter for Mylan´s biologics license application for MYL-1401H, ...
Posted by Michael Wonder on 28 Sep 2017
AbbVie announces global resolution of Humira (adalimumab) patent disputes with Amgen
28 September 2017 - Agreements provide non-exclusive license to Amgen for Humira related intellectual property in the U.S. effective 31 January ...
Posted by Michael Wonder on 23 Sep 2017
FDA clears biotech drug copycats, but buying them isn’t so easy
18 September 2017 - Basically, there’s a gazillion patents,’ says consultant. ...
Posted by Michael Wonder on 18 Sep 2017
Biosimilar cancer drug threat closing in for Roche
19 September 2017 - The long-heralded threat of cut-price competition to its top-selling biological cancer medicines is finally becoming a ...
Posted by Michael Wonder on 14 Sep 2017
FDA approves first biosimilar for the treatment of cancer
14 September 2017 - Mvasi, a biosimilar to the cancer drug Avastin, is approved for certain colorectal, lung, brain, kidney and ...
Posted 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 ...