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RSS FeedPosted by Michael Wonder on 31 Jul 2024
EMA approves Bio-Thera Solutions' BAT1706 (Avzivi, bevacizumab), a biosimilar referencing Avastin
30 July 2024 - Bio-Thera Solutions today announced that the EMA has approved BAT1706 (bevacizumab), a biosimilar referencing Avastin. ...
Posted by Michael Wonder on 26 Jul 2024
Sandoz launches biosimilar Pyzchiva (ustekinumab) across Europe, to treat chronic inflammatory diseases
25 July 2024 - Pyzchiva first ustekinumab biosimilar to launch in Europe with all reference medicine strengths, including 130 mg vial ...
Posted by Michael Wonder on 25 Jul 2024
Bio-Thera Solutions announces regulatory filing acceptance for BAT2206, a proposed biosimilar to Stelara in the US and EU
24 July 2024 - The BAT2206 BLA and MAA are based on a robust analytical, non-clinical and clinical data package ...
Posted by Michael Wonder on 23 Jul 2024
FDA approves Samsung Bioepis’ Epysqli (eculizumab-aagh) as a biosimilar to Soliris (eculizumab)
22 July 2024 - Epysqli is approved for the treatment of patients with paroxysmal nocturnal haemoglobinuria and atypical haemolytic uremic syndrome. ...
Posted by Michael Wonder on 22 Jul 2024
Boehringer Ingelheim and GoodRx announce exclusive patient affordability initiative for adalimumab-adbm injection, Boehringer’s biosimilar to Humira
18 July 2024 - First biosimilar with an exclusive low cash price on the GoodRx platform. ...
Posted by Michael Wonder on 14 Jul 2024
Fresenius announces EMA validation of marketing authorisation application for denosumab biosimilar candidates
11 July 2024 - Fresenius, via its operating company Fresenius Kabi, announced that the EMA has accepted for review the company’s ...
Posted by Michael Wonder on 10 Jul 2024
Outlook Therapeutics announces UK MHRA marketing authorisation of Lytenava (bevacizumab gamma) for the treatment of wet AMD
8 July 2024 - Initial commercial launches of Lytenava (bevacizumab gamma) in the EU and UK anticipated in calendar Q1, 2025. ...
Posted by Michael Wonder on 03 Jul 2024
Formulary coverage of brand name adalimumab and biosimilars across Medicare Part D plans
2 July 2024 - Adalimumab (Humira) is a top-selling drug in Medicare Part D, representing $4.7 billion of Medicare spending in ...
Posted by Michael Wonder on 02 Jul 2024
Altos Biologics files for approval of aflibercept biosimilar
1 July 2024 - Alteogen announced on 1 July that its subsidiary, Altos Biologics submitted a marketing authorisation application to ...
Posted by Michael Wonder on 01 Jul 2024
FDA grants approval for Eylea biosimilar FYB203/Azhantive (aflibercept-mrbb)
28 June 2024 - Formycon and its licensing partner Klinge Biopharma announce that the US FDA today approved FYB203/Azhantive (aflibercept-mrbb), ...
Posted by Michael Wonder on 01 Jul 2024
FDA approves biosimilar Pyzchiva (ustekinumab-ttwe), to be commercialised by Sandoz in US
1 July 2024 - FDA granted provisional determination for interchangeability designation for Pyzchiva. ...
Posted by Michael Wonder on 26 Jun 2024
Tofidence (tocilizumab), a biosimilar referencing RoActemra, approved in the European Union
24 June 2024 - Tofidence complements existing portfolio of immunology biosimilars commercialised by Biogen ...
Posted by Michael Wonder on 29 May 2024
FDA approves first interchangeable biosimilar for two rare diseases
28 May 2024 - Today, the US FDA approved Bkemv (eculizumab-aeeb) as the first interchangeable biosimilar to Soliris (eculizumab) to ...
Posted by Michael Wonder on 28 May 2024
Fresenius announces FDA acceptance for review of denosumab biosimilar application
27 May 2024 - Fresenius announced today that the US FDA has accepted for review the company’s biologics license application ...
Posted by Michael Wonder on 25 May 2024
EMA validates Henlius and Organon filings for Prolia and Xgeva (denosumab) biosimilar candidate HLX14
24 May 2024 - Shanghai Henlius Biotech and Organon today announced that the EMA has validated the marketing authorisation applications for ...