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RSS FeedPosted by Michael Wonder on 23 Aug 2021
Europe has its first Lucentis biosimilar, Samsung Bioepis’ Byooviz
23 August 2021 - Novartis and Roche’s big-selling eye drug Lucentis has its first biosimilar competitor in Europe, after the ...
Posted by Michael Wonder on 02 Jul 2021
Formycon and Bioeq announce submission of the marketing authorisation application for FYB201, a biosimilar candidate to Lucentis (ranibizumab) to the EMA
29 June 2021 - Formycon and its license partner Bioeq AG announce that the marketing authorisation application for FYB201, Formycon’s ...
Posted by Michael Wonder on 27 Jun 2021
Samsung Bioepis and Biogen receive positive CHMP opinion for ranibizumab biosimilar, Byooviz
25 June 2021 - Samsung Bioepis and Biogen today announced that the EMA's CHMP has adopted a positive opinion for Byooviz, ...
Posted by Michael Wonder on 11 May 2021
US, EU regulators discuss tailoring biosimilar approvals
11 May 2021 - A tailored approach to biosimilar approvals is conceived as the next big leap for regulatory advancement in ...
Posted by Michael Wonder on 16 Feb 2021
Celltrion Healthcare receives European Commission approval for the first high concentration, low-volume and citrate-free biosimilar adalimumab, Yuflyma (CT-P17)
15 February 2021 - Yuflyma is approved in all intended indications for the treatment of multiple chronic inflammatory diseases. ...
Posted by Michael Wonder on 26 Nov 2020
Bio-Thera Solutions submits marketing authorisation application for BAT1706, a proposed biosimilar to Avastin, to European Medicines Agency
25 November 2020 - Bio-Thera Solutions today announced that it has submitted the marketing authorisation application for BAT1706, a proposed biosimilar ...
Posted by Michael Wonder on 19 Nov 2020
Alvotech announces that the U.S. FDA and EMA have accepted regulatory submissions for AVT02, a proposed biosimilar to Humira (adalimumab)
19 November 2020 - Alvotech is developing AVT02 as a proposed biosimilar to Humira (adalimumab) with high concentration (100 mg/mL) dosage ...
Posted 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 ...