Blog
RSS FeedPosted by Michael Wonder on 03 Dec 2018
Celltrion seeks European approval for Remsima SC
3 December 2018 - South Korean biopharmaceutical firm Celltrion said Monday that it has sought European approval for the sale ...
Posted by Michael Wonder on 27 Nov 2018
Sandoz receives eighth European Commission approval for a biosimilar with Ziextenzo (pegfilgrastim)
27 November 2018 - Biosimilar Ziextenzo (pegfilgrastim), a long-acting version of supportive oncology medicine filgrastim, is now approved for use in ...
Posted by Michael Wonder on 25 Nov 2018
European Commission approves Pelmeg (pegfilgrastim) as a biosimilar treatment to reduce the duration of neutropenia and incidence of febrile neutropenia in adults treated with chemotherapy
23 November 2018 - Pelmeg was developed by Cinfa Biotech, now part of the Mundipharma network of independent associated companies. ...
Posted by Michael Wonder on 07 Nov 2018
AbbVie announces Humira (adalimumab) global patent license with Momenta
6 November 2018 - AbbVie announced today patent license agreements with Momenta over its proposed biosimilar adalimumab product. ...
Posted by Michael Wonder on 04 Nov 2018
Are rumours of AbbVie's Humira price cuts what they seem?
2 November 2018 - In an effort to combat competition from biosimilar adalimumab products in Europe as patents covering the ...
Posted by Michael Wonder on 01 Nov 2018
AbbVie offers a ‘huge’ discount on Humira to fend off European rivals
1 November 2018 - In hopes of fending off biosimilar competition for its franchise drug, AbbVie has apparently won the ...
Posted by Michael Wonder on 22 Oct 2018
Mylan and Biocon announce positive CHMP opinion for Ogivri, biosimilar trastuzumab
19 October 2018 - Mylan and Biocon today announced that the EMA's CHMP has issued a positive opinion recommending approval ...
Posted by Michael Wonder on 11 Oct 2018
Sandoz announces global resolution of biosimilar adalimumab patent disputes, securing patient access
11 October 2018 - Resolution paves way for 2018 launch in key European markets and secures US market entry planned in ...
Posted by Michael Wonder on 24 Sep 2018
Mylan and Biocon announce positive CHMP opinion for Fulphila, biosimilar pegfilgrastim
21 September 2018 - Mylan and Biocon today announced that the European Medicines Agency's CHMP has issued a positive opinion ...
Posted by Michael Wonder on 24 Sep 2018
Cinfa Biotech receives positive CHMP opinion for Pelmeg (pegfilgrastim), a proposed biosimilar to Neulasta
21 September 2018 - The biosimilar company Cinfa Biotech today announced that the EMA's CHMP has issued a positive opinion recommending ...
Posted 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 ...