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RSS FeedPosted 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. ...
Posted 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 ...