Blog
RSS FeedPosted by Michael Wonder on 09 Jun 2020
Mylan and Lupin receive European marketing authorisation for Nepexto, biosimilar etanercept
4 June 2020 - Mylan and Lupin today announced that the European Commission (EC) has granted marketing authorization for Nepexto, ...
Posted by Michael Wonder on 24 May 2020
Fresenius Kabi’s regulatory submission for pegfilgrastim biosimilar accepted for review by EMA
22 May 2020 - Fresenius Kabi announced today that the EMA has accepted for review the company’s marketing authorisation application for ...
Posted by Michael Wonder on 02 Apr 2020
Pfizer receives European approval for oncology biosimilar Ruxience (rituximab)
2 April 2020 - Pfizer today announced that the European Commission has approved Ruxience (rituximab), a monoclonal antibody and biosimilar to ...
Posted by Michael Wonder on 30 Mar 2020
Mylan and Lupin announce positive CHMP opinion for Nepexto, biosimilar etanercept
27 March 2020 - Mylan and Lupin today announced that the EMA's CHMP has adopted a positive opinion recommending the ...
Posted by Michael Wonder on 09 Mar 2020
Celltrion applies for European approval of Humira biosimilar
9 March 2020 - Celltrion said Monday that it applied for the European Medicine Agency’s commercialization approval of CT-P17, a ...
Posted by Michael Wonder on 03 Feb 2020
Pfizer receives positive CHMP opinion for oncology biosimilar, Ruxience (rituximab)
31 January 2020 - Pfizer today announced that the CHMP of the EMA has adopted a positive opinion, recommending marketing ...
Posted by Michael Wonder on 26 Nov 2019
Celltrion Healthcare receives EU marketing authorisation for world’s first subcutaneous formulation of infliximab, Remsima SC, for the treatment of people with rheumatoid arthritis
25 November 2019 - European Union marketing approval is based on the phase I/III study to evaluate pharmacokinetics, efficacy and safety ...
Posted by Michael Wonder on 25 Sep 2019
Paper by European regulators foresees "continuing reduction in clinical data requirements" for biosimilars
24 September 2019 - This month, Elena Wolff-Holz, chair of the EMA’s Biosimilar Medicinal Products Working Party, together with co-authors from ...
Posted by Michael Wonder on 23 Sep 2019
Celltrion Healthcare receives CHMP positive opinion for novel subcutaneous formulation of CT-P13 (biosimilar infliximab) for the treatment of people with rheumatoid arthritis
23 September 2019 - CHMP positive opinion is based on the phase I/III study to evaluate pharmacokinetics, efficacy and safety between ...
Posted 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 ...