The US FDA's removal of two indications from the label of Sandoz Inc.'s Erelzi (etanercept-szzs), a licensed but not-yet-marketed biosimilar version of the tumor necrosis factor blocker Enbrel (etanercept), appears to be part of Sandoz's legal strategy in its patent dispute with reference product holder Amgen Inc.
A court ruling on whether the company can defend against infringement claims by carving out two of the biosimilar's five approved indications could have legal and regulatory ramifications for other
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