23 March 2018 - Recommended for approval for the same indications as Herceptin (trastuzumab) positive opinion for ABP 980 is ...
23 March 2018 - Positive opinion is based on comprehensive clinical and non-clinical data that is expected to confirm that Sandoz ...
2 March 2018 - STADA Arzneimittel was informed today by Gedeon Richter that the EMA has accepted the regulatory resubmission ...
14 February 2018 - Celltrion’s Herzuma (trastuzumab biosimilar) receives EU approval for early breast cancer, metastatic breast cancer, and metastatic ...
18 January 2018 - First biosimilar bevacizumab approved in the European Union. ...
18 December 2017 - Fresenius Kabi has submitted a marketing authorisation application to the EMA for its adalimumab biosimilar candidate of ...
7 December 2017 - The EMA has accepted for review of Mumbai-based pharmaceutical company USV Pvt. Ltd’s marketing application for ...
30 November 2017 - Mylan and Biocon today announced that the EMA has accepted for review Mylan's marketing authorisation applications ...
22 November 2017 - Biosimilars have been available in the European Union since 2006. However, their uptake in routine care is ...
20 November 2017 - Samsung Bioepis sets an industry record by obtaining European regulatory approval for four biosimilars in just two ...
13 November 2017 - Approval follows recent positive CHMP opinion and FDA approval of Cyltezo. ...
7 November 2017 - Biocon´s partner Mylan has resubmitted the marketing authorisation applications for our proposed biosimilar trastuzumab and pegfilgrastim with ...
27 October 2017 - Comprehensive data package demonstrates that Sandoz biosimilar pegfilgrastim matches the reference biologic in terms of safety, efficacy ...
4 October 2017 - Cinfa Biotech today reported acceptance of the marketing authorisation application by the EMA for its lead ...
15 September 2017 - Recommendation based on extensive analytical, pharmacological, non–clinical & clinical data, which demonstrated similarity of Cyltezo/BI 695501 to ...