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Sandoz Inc.

Division of Novartis AG
www.us.sandoz.com

Latest From Sandoz Inc.

Advances On the Biosimilar Litigation Battlefield

A look at the evolution of litigation, from Amgen's 'bold' at-risk launch of Herceptin and Avastin biosimilars to the jump in settlements, new battles over manufacturing information and an expected petition to the Supreme Court.

Biosimilars Intellectual Property

Amgen Could Block Enbrel Biosimilars For Another Decade As Court Rules Stealth Patents Valid

Court rejects Sandoz's arguments that patents covering Enbrel's active ingredient and method of manufacture are invalid; decision comes three years after FDA approved Sandoz's biosimilar.

Biosimilars Intellectual Property

Biosimilars Sponsors Seek Changes In US FDA Guidance On Comparative Analytical Assessments

Companies generally support decision not to require statistical equivalence testing but challenge agency’s skepticism about combining data from US and foreign reference products to set analytical similarity acceptance criteria.

Biosimilars Biologics

US FDA, USP Cooperate On Small Molecule Drug Monograph Updates To Speed ANDAs

Generic applicants can request monograph changes while FDA assessment is ongoing.

Generic Drugs Review Pathway
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