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RSS FeedPosted by Michael Wonder on 07 Oct 2020
Samsung Bioepis and Biogen announce EMA filing acceptance of SB11, a proposed biosimilar referencing Lucentis (ranibizumab)
6 October 2020 - Samsung Bioepis and Biogen today announced that the EMA has accepted for review the marketing authorisation Application ...
Posted by Michael Wonder on 01 Oct 2020
Centus Biotherapeutics receives European marketing authorisation for Equidacent, biosimilar Avastin
29 September 2020 - Centus Biotherapeutics, a joint venture between Fujifilm Kyowa Kirin Biologics and AstraZeneca, today announced that the ...
Posted by Michael Wonder on 21 Aug 2020
Samsung Bioepis receives European Commission approval for Aynbintio (bevacizumab)
20 August 2020 - Aybintio is Samsung Bioepis’ fifth biosimilar to be approved by the European Commission. ...
Posted by Michael Wonder on 30 Jul 2020
Henlius and Accord Healthcare receive EMA approval for Zercepac, trastuzumab biosimilar
29 July 2020 - The European Commission has approved Shanghai Henlius Biotech and Accord Healthcare's Zercepac, a biosimilar trastuzumab, for ...
Posted by Michael Wonder on 28 Jul 2020
European Commission grants marketing authorisation for world’s first subcutaneous formulation of infliximab, Remsima SC, for an additional five indications including for use in inflammatory bowel disease and ankylosing spondylitis
27July 2020 - The EU marketing authorisation is based on pivotal data comparing the pharmacokinetics, efficacy and safety of the intravenous ...
Posted by Michael Wonder on 29 Jun 2020
Samsung Bioepis receives positive CHMP opinion for Aybintio (bevacizumab)
26 June 2020 - Abbintio, a biosimilar candidate referencing Avastin (bevacizumab), is Samsung Bioepis’ second oncology biosimilar to be recommended for ...
Posted 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 ...