Blog
RSS FeedPosted 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16 August 2017 - Biocon has withdrawn its application seeking European Union approval for two drugs after the EU drugs ...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 ...
Posted by Michael Wonder on 19 Jun 2017
Sandoz receives approval in Europe for Rixathon (biosimilar rituximab) to treat blood cancers and immunological diseases
19 June 2017 - Sandoz now has four biosimilars approved in Europe — more than any other company. ...
Posted by Michael Wonder on 31 May 2017
Sandoz proposed biosimilars adalimumab and infliximab accepted for regulatory review by the European Medicines Agency
31 May 2017 - These regulatory submissions follow soon after two positive CHMP opinions for Sandoz biosimilars etanercept and rituximab further ...
Posted by Michael Wonder on 23 May 2017
Fujifilm Kyowa Kirin Biologics announces marketing authorisation application for FKB327 accepted for review by European Medicines Agency
22 May 2017 - Fujifilm Kyowa Kirin Biologics announces that on May 18, 2017, the EMA has accepted for review the ...
Posted by Michael Wonder on 20 May 2017
Sanofi receives CHMP recommendation for approval of insulin lispro biosimilar
19 May 2017 - Positive opinion based on a clinical development program involving over 1,000 people with type 1 or ...
Posted by Michael Wonder on 06 May 2017
New guide on biosimilar medicines for health care professionals
5 May 2017 - Increasing understanding of biosimilar medicines. ...
Posted by Michael Wonder on 22 Apr 2017
Sandoz proposed biosimilars rituximab and etanercept recommended for approval in Europe
21 April 2017 - Subject to EC approval, Sandoz market leadership position extended as the only company to have five approved ...
Posted by Michael Wonder on 24 Mar 2017
European Commission approves Amgevita (biosimilar adalimumab) for the treatment of certain inflammatory diseases
23 March 2017 - First biosimilar adalimumab approved in the European Union. ...
Posted by Michael Wonder on 10 Mar 2017
EBE, EFPIA and IFPMA have today launched a position paper entitled “Considerations for physicians on switching decisions regarding biosimilars”
9 March 2017 - Switching describes a physician's decision to exchange one product that a patient receives for another. ...
Posted by Michael Wonder on 24 Feb 2017
Mundipharma to launch Truxima (rituximab), the first biosimilar monoclonal antibody for the treatment of cancer, in seven European markets
22 February 2017 - Truxima is expected to cost less than the reference product and the hope is that these savings ...
Posted by Michael Wonder on 23 Feb 2017
Celltrion’s Rituxan biosimilar wins European approval
22 February 2017 - Truxima slated to hit European markets in Q2. ...