Blog
RSS FeedPosted by Michael Wonder on 11 Sep 2019
Biosimilar and interchangeable: inseparable scientific concepts?
4 September 2019 - As defined by the European Commission, the term interchangeability refers to “the possibility of exchanging one medicine ...
Posted by Michael Wonder on 29 Aug 2019
EMA offers edits on FDA draft guidance on biosimilars
29 August 2019 - Although regulators rarely offer public comments on another regulator’s guidance, the European Medicines Agency (EMA) late ...
Posted by Michael Wonder on 20 Jul 2019
EU starts evaluating Samsung Bioepis’ sales application for Avastin biosimilar
19 July 2019 - Samsung Bioepis said that the EMA has started evaluating its application to market SB8, an Avastin ...
Posted by Michael Wonder on 24 Jun 2019
European Medicines Agency accepted first "China-Developed" biosimilar - Henlius HLX02 marketing authorisation application for review
21 June 2019 - First China-developed trastuzumab biosimilar accepted for MAA review by the EMA. ...
Posted by Michael Wonder on 31 May 2019
Pfenex and Alvogen announce European Medicines Agency accepts marketing authorisation application for PF708
30 May 2019 - Pfenex and Alvogen today announced that the EMA has accepted the marketing authorisation application submitted by our ...
Posted by Michael Wonder on 29 May 2019
European Medicines Agency accepts marketing authorisation application for Prestige BioPharma’s trastuzumab biosimilar HD201 for review
28 May 2019 - Prestige BioPharma announced that EMA has validated and accepted for review the marketing authorisation application for ...
Posted by Michael Wonder on 28 Apr 2019
Evolus receives positive CHMP opinion for Nuceiva in the European Union
26 April 2019 - European Commission approval anticipated within 90 days. ...
Posted by Michael Wonder on 04 Apr 2019
Fresenius Kabi receives European Commission approval for adalimumab biosimilar Idacio
3 April 2019 - The European Commission granted Fresenius Kabi the marketing authorization for Idacio, an adalimumab biosimilar, for all indications ...
Posted by Michael Wonder on 06 Mar 2019
Samsung Bioepis gains approval to sell bigger size Ontruzant in Europe
5 March 2019 - Samsung Bioepis has gained approval to sell bigger-size Ontruzant in Europe, the company said Tuesday. ...
Posted by Michael Wonder on 20 Feb 2019
Pfizer receives European approval for Zirabev (bevacizumab), a biosimilar to Avastin
19 February 2019 - Pfizer today announced the European Commission has approved Zirabev for the treatment of metastatic carcinoma of ...
Posted by Michael Wonder on 04 Feb 2019
Fresenius Kabi receives positive CHMP opinion for MSB11022, a biosimilar candidate of adalimumab
1 February 2019 - Fresenius Kabi announced today that the CHMP of the EMA has issued a positive opinion, recommending marketing ...
Posted by Michael Wonder on 21 Jan 2019
Europe closer to biosimilar rule change, despite fierce resistance from pharma
18 January 2019 - EFPIA says it weakens IP commitment - supporters say it will boost exports. ...
Posted by Michael Wonder on 20 Dec 2018
Biosimilar trastuzumab co-developed by Biocon receives approval in the EU
19 December 2018 - Ogivri, a biosimilar Trastuzumab jointly developed by Biocon and Mylan, has been approved in the EU. ...
Posted by Michael Wonder on 17 Dec 2018
Pfizer receives positive CHMP opinion for oncology biosimilar Zirabev (bevacizumab)
14 December 2018 - Zirabev (bevacizumab), a potential biosimilar to Avastin (bevacizumab), is Pfizer's second therapeutic oncology biosimilar to receive a ...
Posted by Michael Wonder on 03 Dec 2018
Biosimilar pegfilgrastim co-developed by Biocon receives approval in EU
30 November 2018 - Fulphila, a biosimilar pegfilgrastim jointly developed by Biocon and Mylan, has been approved in EU. ...