Blog
RSS FeedPosted by Michael Wonder on 24 Sep 2018
Sandoz receives positive CHMP opinion for proposed biosimilar pegfilgrastim
21 September 2018 - Positive opinion is based on comprehensive data confirming that Sandoz biosimilar pegfilgrastim matches the reference medicine in ...
Posted by Michael Wonder on 20 Sep 2018
EU green light for new Humira biosimilar
20 September 2018 - The European Commission has approved Mylan and Fujifilm Kyowa Kirin Biologics’ Humira biosimiar Hulio. ...
Posted by Michael Wonder on 13 Sep 2018
Improving understanding of biosimilars in the EU
13 September 2018 - New information material made available in several European languages. ...
Posted by Michael Wonder on 01 Aug 2018
Pfizer receives European approval for oncology biosimilar Trazimera (trastuzumab)
31 July 2018 - The European Commission decision marks the approval of Pfizer's first therapeutic oncology biosimilar. ...
Posted by Michael Wonder on 30 Jul 2018
Mylan and Fujifilm Kyowa Kirin Biologics announce positive CHMP opinion for Hulio, biosimilar adalimumab
27 July 2018 - Mylan and Fujifilm Kyowa Kirin Biologics Co., Ltd. today announced that the EMA's CHMP has adopted ...
Posted 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 ...