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Regulatory Approval European Commission

Goodwin

Samsung Bioepis Secures Marketing Approval in Korea for its Biosimilar to Amgen’s Bone Cancer Drug Xgeva

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Samsung Bioepis Co., Ltd. has secured marketing approval in Korea for XBRYK, its biosimilar to Amgen’s bone cancer drug XGEVA, used to prevent fractures in those with bone metastases from solid tumors or multiple myeloma and...more

Goodwin

Biosimilar Regulatory Approval Updates

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​​​​​​​Teva announced today that the European Commission has granted marketing authorization for RANIVISIO, a biosimilar ranibizumab, for the treatment of age-related macular degeneration (AMD). Teva entered into a strategic...more

MoFo Life Sciences

The European Commission’s New Pharmaceutical Strategy For Europe

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On November 25, 2020, the European Commission (the “Commission”) published its “Pharmaceutical Strategy for Europe” which outlines the Commission’s multi-year vision for a more patient-centered pharmaceutical system. The...more

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