Samsung Bioepis Co., Ltd.
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While US biosimilar approvals have been thin on the ground in 2021 – with products delayed due to the FDA’s inability to conduct certain facility inspections during the COVID-19 pandemic – the market has nevertheless seen several firsts this year, including two interchangeability designations and the first ophthalmic biosimilar approval.
Samsung Bioepis’ etanercept biosimilar, freely available in Europe, will not be sold in the US until patent expiry in 2029 following action by a US district court.
After an extraordinary year that saw demand patterns and the supply chain upended by the COVID-19 pandemic, as well as a major merger that has transformed one of the global off-patent industry’s biggest players, Generics Bulletin’s Top 50 has once again seen significant changes.
Samsung Bioepis has confirmed completion of its Phase III trial for a proposed biosimilar to Soliris, putting it ahead of rival developer Amgen which has negotiated a date-certain US launch.
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