Samsung Bioepis Begins Denosumab Trials

Company Also Announces Successful Ranibizumab Phase III Trials And US Filing

 
• By Akriti Seth
  
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Samsung Bioepis has announced that its Prolia/Xgeva (denosumab) biosimilar, SB16, has begun Phase I clinical trials. Further, the company’s Lucentis (ranibizumab) biosimilar, SB11, has produced positive Phase III data and has been filed in the US. Meanwhile, CEO and president Christopher Hansung Ko has commented on the impact of the coronavirus pandemic on the industry and competition from domestic companies in the Chinese market. 

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Samsung Bioepis makes progress with denosumab and ranibizumab biosimilar candidates • Source: Shutterstock

Samsung Bioepis has announced the initiation of Phase I clinical trials for its Prolia/Xgeva (denosumab) biosimilar, SB16. The joint venture between Samsung BioLogics and Biogen confirmed that the Phase I clinical trial for SB16 will be a randomized, double-blind, three-arm, parallel group, single-dose study to compare the pharmacokinetics, pharmacodynamics, safety, tolerability and immunogenicity between SB16 and Prolia in healthy 25-55 year old male volunteers.

Celltrion also began Phase I clinical trials of its denosumab biosimilar candidate, CT-P41, in September. Also see "Celltrion To...

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