Blog
RSS FeedPosted by Michael Wonder on 29 Jul 2018
Sandoz receives European Commission approval for biosimilar Hyrimoz (adalimumab)
27 July 2018 - Biosimilar Hyrimoz (adalimumab) approved for use in all same indications as reference medicine including rheumatology, gastroenterology and ...
Posted by Michael Wonder on 29 Jul 2018
Coherus Biosciences receives positive CHMP opinion for Udencya (pegfilgrastim biosimilar candidate)
27 July 2018 - Coherus BioSciences today announced the CHMP of the EMA has adopted a positive opinion for the ...
Posted by Michael Wonder on 05 Jun 2018
Lupin submits marketing authorisation application for etanercept biosimilar in Europe
23 May 2018 - Pharma major Lupin announced today that its marketing authorization application for a biosimilar of etanercept has been ...
Posted by Michael Wonder on 02 Jun 2018
Sandoz receives positive CHMP opinion for proposed biosimilar adalimumab
1 June 2018 - Sandoz is seeking approval of proposed biosimilar adalimumab for use in all reference medicine indications including those ...
Posted by Michael Wonder on 24 May 2018
Sandoz receives European Commission approval for Zessly (infliximab) in gastroenterological, rheumatological and dermatological diseases
24 May 2018 - Zessly is the third EC approval for a Sandoz biosimilar in 12 months. ...
Posted by Michael Wonder on 03 May 2018
How the U.S. compares to Europe on biosimilar approvals and products in the pipeline
2 May 2018 - FDA has not approved any biosimilar drug in 2018. ...
Posted by Michael Wonder on 03 May 2018
Herzuma (trastuzumab), a biosimilar for the treatment of breast cancer, now available in Europe
2 May 2018 - Herzuma is the third biosimilar to be marketed and distributed by the Mundipharma network in Europe, which ...
Posted by Michael Wonder on 30 Apr 2018
Access to biosimilars in EU expected to continue to outpace US and Canada
27 April 2018 - Biosimilar experts from across the EU continued to show how rapidly biosimilars have gained market share, ...
Posted by Michael Wonder on 28 Mar 2018
Mylan and Biocon receive approvals from the European Commission and TGA Australia for Semglee, biosimilar insulin glargine
27 March 2018 - Mylan and Biocon today announced that their co-developed biosimilar insulin glargine Semglee has received marketing authorisation ...
Posted by Michael Wonder on 27 Mar 2018
An update on the clinical evidence that supports biosimilar approvals in Europe
25 March 2018 - This study gives an update regarding biosimilar development in practice by reviewing the clinical development programs of ...
Posted by Michael Wonder on 23 Mar 2018
Amgen and Allergan receive positive CHMP opinion for ABP 980 (biosimilar Herceptin) for the treatment of three types of cancer
23 March 2018 - Recommended for approval for the same indications as Herceptin (trastuzumab) positive opinion for ABP 980 is ...
Posted by Michael Wonder on 23 Mar 2018
Sandoz receives positive CHMP opinion for proposed biosimilar infliximab
23 March 2018 - Positive opinion is based on comprehensive clinical and non-clinical data that is expected to confirm that Sandoz ...
Posted by Michael Wonder on 04 Mar 2018
EMA started the evaluation of resubmitted marketing authorisation application for biosimilar pegfilgrastim
2 March 2018 - STADA Arzneimittel was informed today by Gedeon Richter that the EMA has accepted the regulatory resubmission ...
Posted by Michael Wonder on 15 Feb 2018
Celltrion receives EU approval for trastuzumab biosimilar
14 February 2018 - Celltrion’s Herzuma (trastuzumab biosimilar) receives EU approval for early breast cancer, metastatic breast cancer, and metastatic ...
Posted by Michael Wonder on 19 Jan 2018
European Commission approves Amgen and Allergan's Mvasi (biosimilar bevacizumab) for the treatment of certain types of cancer
18 January 2018 - First biosimilar bevacizumab approved in the European Union. ...