Blog
RSS FeedPosted by Michael Wonder on 19 Dec 2017
Fresenius submits first biosimilar marketing authorisation application
18 December 2017 - Fresenius Kabi has submitted a marketing authorisation application to the EMA for its adalimumab biosimilar candidate of ...
Posted by Michael Wonder on 07 Dec 2017
EU regulator accepts USV’s application for biosimilar pegfilgrastim
7 December 2017 - The EMA has accepted for review of Mumbai-based pharmaceutical company USV Pvt. Ltd’s marketing application for ...
Posted by Michael Wonder on 02 Dec 2017
European Medicines Agency accepts marketing authorisation applications for Mylan and Biocon's proposed biosimilars trastuzumab and pegfilgrastim
30 November 2017 - Mylan and Biocon today announced that the EMA has accepted for review Mylan's marketing authorisation applications ...
Posted by Michael Wonder on 28 Nov 2017
Comparing safety information of biosimilars with their originators: a cross-sectional analysis of European Risk Management Plans
22 November 2017 - Biosimilars have been available in the European Union since 2006. However, their uptake in routine care is ...
Posted by Michael Wonder on 20 Nov 2017
Samsung Bioepis receives regulatory approval for Europe's first trastuzumab biosimilar, Ontruzant
20 November 2017 - Samsung Bioepis sets an industry record by obtaining European regulatory approval for four biosimilars in just two ...
Posted by Michael Wonder on 14 Nov 2017
Cyltezo, adalimumab biosimilar from Boehringer Ingelheim, approved in Europe for the treatment of multiple chronic inflammatory diseases
13 November 2017 - Approval follows recent positive CHMP opinion and FDA approval of Cyltezo. ...
Posted by Michael Wonder on 08 Nov 2017
Company statement on resubmission of biosimilar trastuzumab and pegfilgrastim dossiers with EMA
7 November 2017 - Biocon´s partner Mylan has resubmitted the marketing authorisation applications for our proposed biosimilar trastuzumab and pegfilgrastim with ...
Posted by Michael Wonder on 27 Oct 2017
Sandoz proposed biosimilar pegfilgrastim accepted by EMA for regulatory review
27 October 2017 - Comprehensive data package demonstrates that Sandoz biosimilar pegfilgrastim matches the reference biologic in terms of safety, efficacy ...
Posted by Michael Wonder on 07 Oct 2017
European Medicines Agency accepts marketing authorisation application for Cinfa Biotech’s pegfilgrastim biosimilar B12019 for review
4 October 2017 - Cinfa Biotech today reported acceptance of the marketing authorisation application by the EMA for its lead ...
Posted by Michael Wonder on 17 Sep 2017
Boehringer Ingelheim receives positive CHMP opinion for adalimumab biosimilar Cyltezo
15 September 2017 - Recommendation based on extensive analytical, pharmacological, non–clinical & clinical data, which demonstrated similarity of Cyltezo/BI 695501 to ...
Posted by Michael Wonder on 17 Sep 2017
Samsung Bioepis first to receive positive CHMP opinion on a trastuzumab biosimilar with Ontruzant
15 September 2017 - Ontruzant is the first biosimilar candidate referencing Herceptin (trastuzumab) to receive a positive opinion from the EMA’s ...
Posted by Michael Wonder on 25 Aug 2017
Samsung Bioepis first to obtain European Commission approval for a third anti-TNF-α biosimilar with Imraldi (adalimumab)
24 August 2017 - Samsung Bioepis today announced the European Commission’s approval of Imraldi, a biosimilar referencing Humira (adalimumab), for the ...
Posted by Michael Wonder on 20 Aug 2017
Biocon pulls application for EU approval of two drugs
16 August 2017 - Biocon has withdrawn its application seeking European Union approval for two drugs after the EU drugs ...
Posted by Michael Wonder on 27 Jun 2017
Sandoz receives approval in Europe for Erelzi (biosimilar etanercept) to treat multiple inflammatory diseases
27 June 2017 - European Commission approves Sandoz Erelzi to treat immunological diseases such as rheumatoid arthritis, psoriasis, and psoriatic arthritis. ...
Posted by Michael Wonder on 26 Jun 2017
Samsung Bioepis' Imraldi (adalimumab) recommended for approval by European Medicines Agency
23 June 2017 - The positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use will now ...