Pfizer Is King Of The US Biosimilar Hill

Four biosimilar candidates are under US FDA review, including what could be Pfizer’s eighth biologic approved under FDA’s 351(k) biologics license application pathway.

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Two biosimilar approvals in less than a month have extended Pfizer Inc.’s already dominant position in the US biosimilars space, bringing the big pharma’s tally of 351(k) biologics license application approvals to seven – accounting for almost one-third of the FDA’s total of 23 approvals using the biosimilar pathway.

The FDA approved Pfizer’s Ruxience (rituximab-pvvr) on 23 July 2019 after clearing the company’s

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