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U.S. FDA panel backs Celltrion copycat of Roche blood cancer drug

Reuters 

(Reuters) - Inc's <068270.KS> of blockbuster drug, Rituxan, on Wednesday won unanimous backing from an advisory panel to the

The tussles in the biosimilars market are a growing focus for investors, with soaring valuations for some pioneers in the field, including Celltrion, and worries about the long-term sales threat to makers of the original drugs such as Roche and .

The vote comes after FDA staff reviewers https://said Celltrion's biosimilar, CT-P10, was highly similar to The agency usually, but not always, follows the advice of its advisory panels.

The FDA had in February declined to approve https://www.com/en/pr/newsDetail.do?seq=482 the copycat drug, citing issues related to a certain at

has partnered with Israel's to commercialise CT-P10 in the and

Biological drugs such as are complex molecules made inside living cells, which means rivals looking to make copies when patents expire can only produce medicines similar to the original rather than identical.

Switzerland-based Roche, the world's biggest of drugs, is stepping up cost cuts in an efficiency drive made unavoidable by competition from cut-price biosimilars of its three best-selling drugs Rituxan, and

brought in sales of $3.53 billion in the first half of 2018, a 9 percent drop from a year earlier, mainly due to the launch of biosimilars in most EU markets.

(Reporting by in Bengaluru; Editing by and Sriraj Kalluvila)

(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.)

First Published: Thu, October 11 2018. 06:46 IST
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