Blog
RSS FeedPosted 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. ...
Posted by Michael Wonder on 30 Jan 2017
Amgen receives positive CHMP opinion for ABP 501 (biosimilar adalimumab) for the treatment of certain inflammatory diseases
27 January 2017 - First adalimumab biosimilar candidate recommended for EMA approval. ...
Posted by Michael Wonder on 28 Jan 2017
EMA recommends two Amgen Humira biosimilars
27 January 2017 - The EMA's CHMP on Thursday recommended eight medicines for approval, including two Amgen biosimilars for AbbVie’s ...
Posted by Michael Wonder on 24 Jan 2017
European Commission initiative improves information for patients on biosimilar medicines
23 January 2017 - For the third year in a row, the European Commission will organise a multi-stakeholder workshop on biosimilar ...
Posted by Michael Wonder on 19 Jan 2017
Boehringer Ingelheim biosimilar candidate to Humira accepted for EMA and FDA regulatory review
18 January 2017 - BI 695501 EMA and FDA applications are first biosimilar regulatory filings for Boehringer Ingelheim. ...
Posted by Michael Wonder on 18 Jan 2017
Europe's oncologists back biosimilar versions of cancer drugs
18 January 2017 - Europe's leading association of oncologists has thrown its weight behind cheaper copycat versions of biotech cancer ...