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Sandoz Inc.

Division of Novartis AG
www.us.sandoz.com

Latest From Sandoz Inc.

AbbVie's Fourth Humira Patent Settlement Allows Sandoz Biosimilar US Entry Eight Months After Amgen

Sandoz joins list of companies that opt to settle rather than challenge AbbVie's hefty patent portfolio; staggered launches offer model for future deals.

Biosimilars Intellectual Property

Celltrion’s Rituximab Biosimilar Has Easy US FDA Panel Ride Despite Questions About Narrow Label

Oncologic Drugs Advisory Committee says totality of evidence supports licensure of CT-P10 for three lymphoma indications, but panelists question what additional data would be needed to eventually get Rituxan’s other approved uses, which were carved out for patent and exclusivity reasons, onto the biosimilar’s label.

Advisory Committees Biosimilars

Biosimilar Suffixes Appear Superfluous In Adverse Event Reporting

Nearly all adverse event reports received by US FDA include brand name of biosimilar, raising questions as to whether suffix on nonproprietary name is necessary for pharmacovigilance.
Biosimilars Drug Safety

Biosimilar Patent Settlements: What Terms May Spur Antitrust Actions?

AbbVie's Humira settlements suggest issues that FTC will be scrutinizing, such as biosimilar entry date, royalty payments, and acceleration clauses.

Biosimilars Legal Issues
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