Sandoz application for proposed biosimilar adalimumab’s high concentration formulation accepted by EMA

17 June 2022 - Submission supported by comprehensive analytical and clinical data from new Phase I bridging pharmacokinetics study. ...

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FDA approves Riabni (rituximab-arrx), a biosimilar to Rituxan (rituximab), for adults with moderate to severe rheumatoid arthritis

6 June 2022 - Now approved to treat all available Rituxan Indications. ...

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Biogen and Samsung Bioepis’ Byooviz (ranibizumab-nuna) launches in the United States

2 June 2022 - Byooviz, priced 40% lower than Lucentis, provides an equally effective and more affordable treatment option to patients ...

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Schedule of Pharmaceutical Benefits - 1 June 2022

1 June 2022 - The June 2022 issue of the Schedule of Pharmaceutical Benefits is out and now in effect. ...

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Sandoz announces new global ‘Act4Biosimilars’ initiative, to improve patient access and increase adoption by at least 30% in 30+ countries by 2030

31 May 2022 - Multidisciplinary Steering Committee established to drive action includes patient advocacy leaders, healthcare professionals, biosimilar experts and industry ...

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Xbrance provides update on ranibizumab biosimilar candidate FDA filing

30 May 2022 - Xbrane Biopharma has withdrawn its biologics license application for its investigational biosimilar candidate to Lucentis after ...

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2022 Biosimilar Awareness Week: 30 May – 3 June

30 May 2022 - Marking a new dawn in medicine choice and affordability. ...

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Amneal achieves third U.S. biosimilar approval with Fylnetra (pegfilgrastim-pbbk)

27 May 2022 - Marks Amneal’s third biosimilar approval in 2022. ...

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'EMA's refusal to authorise Herceptin biosimilar unfair'

23 May 2022 - Prestige BioPharma's recent failure to get European approval for its Herceptin biosimilar could have resulted from ...

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Viatris and Biocon Biologics launch Abevmy (bevacizumab), their third oncology siosimilar, in Canada

19 May 2022 - Viatris and Biocon Biologics announced today that Abevmy (bevacizumab) is now available in Canada.  ...

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United Kingdom MHRA grants marketing authorisation for FYB201, Formycon's biosimilar for Lucentis

17 May 2022 - Formycon and its license partner Bioeq announce that today the MHRA has granted marketing authorisation in the ...

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Pfizer settles two lawsuits, starts another over etanercept biosimilar in Australia

17 May 2022 - After agreeing to settle with Amgen over its oncology biosimilars, Pfizer issued a new patent lawsuit ...

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Korea clears permit for Samsung Bioepis’ Lucentis biosimilar after US

16 May 2022 - Samsung Bioepis received marketing approval for Amelivu (ranibizumab), a biosimilar referencing Lucentis to treat various eye ...

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Prioritising reference products over biosimilars led to millions of missed savings for Part D

20 April 2022 - Medicare Part D plans missed out on between $84 million and $143 million in savings by ...

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Amneal achieves second U.S. biosimilars approval with Alymsys (bevacizumab-maly)

13 April 2022 - Marks the second of three biosimilars Amneal expects to receive U.S. approval for in 2022. ...

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