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RSS FeedPosted by Michael Wonder on 19 Jan 2017
Boehringer Ingelheim biosimilar candidate to Humira accepted for EMA and FDA regulatory review
18 January 2017 - BI 695501 EMA and FDA applications are first biosimilar regulatory filings for Boehringer Ingelheim. ...
Posted by Michael Wonder on 18 Jan 2017
FDA issues long-awaited biosimilar interchangeability guidance
17 January 2017 - The US FDA has finally released for public consultation its long-awaited draft guidance detailing the agency's ...
Posted by Michael Wonder on 13 Jan 2017
FDA finalises guidance on non-proprietary naming of biologics and biosimilars
12 January 2017 - In a departure from the way the WHO and Europe name biologics, the US FDA has ...
Posted by Michael Wonder on 11 Jan 2017
U.S. FDA accepts biologics license application for Mylan and Biocon's proposed biosimilar trastuzumab
11 January 2017 - If approved, MYL-1401O has potential to be the first biosimilar trastuzumab in the U.S. ...
Posted by Michael Wonder on 30 Dec 2016
FDA completes guidance on the development of biosimilars
29 December 2016 - Drug makers received guidance from the FDA on 28 December on the development of biosimilar medicines. ...
Posted by Michael Wonder on 09 Dec 2016
US Solicitor General calls on Supreme Court to review six-month delays to biosimilar launches
8 December 2016 - With the timing of all future US launches of biosimilars at stake, the US Solicitor General ...
Posted by Michael Wonder on 01 Dec 2016
Biosimilar therapy for ERBB2 (HER2)–positive breast cancer
1 December 2016 - Biologics is an umbrella term for therapeutic agents at least partially derived from living organisms such as ...
Posted by Michael Wonder on 01 Dec 2016
Scientific evidence and financial obligations to ensure access to biosimilars for cancer treatment
1 December 2016 - Articles in medical journals add to the scientific body of research that ultimately influences care. ...
Posted by Michael Wonder on 16 Nov 2016
Amgen and Allergan submit biosimilar biologics license application for ABP 215 to U.S. FDA
15 November 2016 - Supported by phase 3 study in patients with non-squamous non-small-cell lung cancer. ...
Posted by Michael Wonder on 09 Oct 2016
Teva and Celltrion announce exclusive biosimilar commercial partnership
6 October 2016 - Teva Pharmaceutical Industries Ltd and Celltrion Healthcare have announced that the companies have entered into an exclusive ...
Posted by Michael Wonder on 24 Sep 2016
FDA approves Amgen's Amjevita (adalimumab-atto) for treatment of seven inflammatory diseases
23 September 2016 - First biosimilar adalimumab approved by FDA. ...
Posted by Michael Wonder on 30 Aug 2016
FDA approves Sandoz Erelzi to treat multiple inflammatory diseases
30 August 2016 - Erelzi is the first biosimilar etanercept approved by the FDA, offering expanded access to this important medicine. ...
Posted by Michael Wonder on 08 Aug 2016
Merck announces U.S. FDA filing acceptance of new drug application for MK-1293, an investigational follow-on biologic insulin glargine
5 August 2016 - Marketing authorization application to the European Medicines Agency currently under review. ...
Posted by Michael Wonder on 04 Aug 2016
Drugmakers split on whether to include interchangeability statement in biosimilar labels
3 August 2016 - Drug, biologic and biosimilar companies’ comments on US FDA draft guidance on biosimilar labeling reveals a major ...
Posted by Michael Wonder on 19 Jul 2016
FDA knocks back Novartis copy of Amgen's drug Neulasta
19 July 2016 - U.S. regulators have declined to approve Novartis' so-called biosimilar copy of Amgen's Neulasta drug that fights infections ...