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. ...

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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 ...

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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. ...

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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 ...

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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 ...

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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), ...

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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. ...

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Tofidence (tocilizumab), a biosimilar referencing RoActemra, approved in the European Union

24 June 2024 - Tofidence complements existing portfolio of immunology biosimilars commercialised by Biogen ...

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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 ...

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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 ...

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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 ...

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Celltrion receives European Commission approval of Omlyclo (CT-P39), the first and only omalizumab biosimilar approved in Europe

23 May 2024 - The European Commission decision is based on clinical evidence, including results from a Phase 3 clinical trial ...

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Sandoz receives European Commission approval for Wyost and Jubbonti, the first and only biosimilars of denosumab in Europe

22 May 2024 - EC approval based on robust development program confirming that biosimilar matches reference medicine in terms of ...

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Teva and Alvotech announce Simlandi (adalimumab-ryvk) injection now available in the US

20 May 2024 - Simlandi is the first interchangeable high concentration, citrate-free biosimilar to Humira. ...

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FDA approves first interchangeable biosimilars to Eylea to treat macular degeneration and other eye conditions

20 May 2024 - Today, FDA approved Yesafili (aflibercept-jbvf) and Opuviz (aflibercecpt-yszy) as the first interchangeable biosimilars to Eylea (aflibercept). ...

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