Fresenius Kabi receives positive CHMP opinion for MSB11022, a biosimilar candidate of adalimumab

1 February 2019 - Fresenius Kabi announced today that the CHMP of the EMA has issued a positive opinion, recommending marketing ...

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Europe closer to biosimilar rule change, despite fierce resistance from pharma

18 January 2019 - EFPIA says it weakens IP commitment - supporters say it will boost exports. ...

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Biosimilar trastuzumab co-developed by Biocon receives approval in the EU

19 December 2018 - Ogivri, a biosimilar Trastuzumab jointly developed by Biocon and Mylan, has been approved in the EU.  ...

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Pfizer receives positive CHMP opinion for oncology biosimilar Zirabev (bevacizumab)

14 December 2018 - Zirabev (bevacizumab), a potential biosimilar to Avastin (bevacizumab), is Pfizer's second therapeutic oncology biosimilar to receive a ...

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Biosimilar pegfilgrastim co-developed by Biocon receives approval in EU

30 November 2018 - Fulphila, a biosimilar pegfilgrastim jointly developed by Biocon and Mylan, has been approved in EU.  ...

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Celltrion seeks European approval for Remsima SC

3 December 2018 - South Korean biopharmaceutical firm Celltrion said Monday that it has sought European approval for the sale ...

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Sandoz receives eighth European Commission approval for a biosimilar with Ziextenzo (pegfilgrastim)

27 November 2018 - Biosimilar Ziextenzo (pegfilgrastim), a long-acting version of supportive oncology medicine filgrastim, is now approved for use in ...

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European Commission approves Pelmeg (pegfilgrastim) as a biosimilar treatment to reduce the duration of neutropenia and incidence of febrile neutropenia in adults treated with chemotherapy

23 November 2018 - Pelmeg was developed by Cinfa Biotech, now part of the Mundipharma network of independent associated companies. ...

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AbbVie announces Humira (adalimumab) global patent license with Momenta

6 November 2018 - AbbVie announced today patent license agreements with Momenta over its proposed biosimilar adalimumab product.  ...

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Are rumours of AbbVie's Humira price cuts what they seem?

2 November 2018 - In an effort to combat competition from biosimilar adalimumab products in Europe as patents covering the ...

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AbbVie offers a ‘huge’ discount on Humira to fend off European rivals

1 November 2018 - In hopes of fending off biosimilar competition for its franchise drug, AbbVie has apparently won the ...

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Mylan and Biocon announce positive CHMP opinion for Ogivri, biosimilar trastuzumab

19 October 2018 - Mylan and Biocon today announced that the EMA's CHMP has issued a positive opinion recommending approval ...

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Sandoz announces global resolution of biosimilar adalimumab patent disputes, securing patient access

11 October 2018 - Resolution paves way for 2018 launch in key European markets and secures US market entry planned in ...

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Mylan and Biocon announce positive CHMP opinion for Fulphila, biosimilar pegfilgrastim

21 September 2018 - Mylan and Biocon today announced that the European Medicines Agency's CHMP has issued a positive opinion ...

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Cinfa Biotech receives positive CHMP opinion for Pelmeg (pegfilgrastim), a proposed biosimilar to Neulasta

21 September 2018 - The biosimilar company Cinfa Biotech today announced that the EMA's CHMP has issued a positive opinion recommending ...

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