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Sandoz Inc.

Division of Novartis AG
www.us.sandoz.com

Latest From Sandoz Inc.

Two Months To Add Two Words – Biosimilar Supplement Review Times May Be Hindering Uptake

Biosimilar supplement approvals by the US FDA take on average about five months as sponsors request easier and quicker ways to update labels.
Biosimilars Post Market Regulation & Studies

Biosimilar Litigation: Amgen Sues Samsung Bioepis To Enforce 180-Day Notice Requirement

Although Samsung has not provided 180-day advance notice of commercialization for Eticovo, its recently approved biosimilar to Enbrel, Amgen seeks a preliminary injunction because it has reason to believe the company is prepared to launch ‘imminently.’

Biosimilars Legal Issues

Keeping Track: A Glut Of Big Approvals While Lartruvo Makes Its Market Exit

The latest drug development news and highlights from our US FDA Performance Tracker.
Drug Review Regulation

As Amgen's Aimovig Momentum Continues, Challenges To Current Blockbusters Loom Large

Q1 Earnings Preview: While investors will look for updates on Aimovig and Evenity launches and a recently revealed legal battle with partner Novartis, Amgen's current blockbusters also are in the hotseat.

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