Sandoz Reveals Biosimilar Denosumab Program
As Sandoz reported its second-quarter financial results, the firm revealed details of a previously unannounced development program for biosimilar denosumab.
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Henlius Kicks Off Denosumab Trial
Shanghai Henlius Biotech has begun dosing in a Phase I trial for its HLX14 planned biosimilar version of denosumab. Multiple biosimilar developers are vying to take a slice of the market for rivals to Amgen’s Xgeva/Prolia original.
Samsung Bioepis Begins Denosumab Trials
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.
Sandoz Expects Imminent US Pegfilgrastim Action
Sandoz chief Richard Saynor remains confident in the firm’s US pegfilgrastim filing, even though it has been with the FDA for more than six months.