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Sandoz Inc.

Division of Novartis AG
www.us.sandoz.com

Latest From Sandoz Inc.

Former Sandoz Executive Kellum Admits US Price-Fixing

Former Sandoz executive Hector Armando Kellum has admitted involvement in a US generic price-fixing conspiracy, the US Department of Justice has announced.

Legal Issues United States

Pharma Enforcement Remains 'Priority Area' In FTC's 2021 Budget Request

US Federal Trade Commission has mainly focused in pay-for-delay cases over the past decade, but pricing strategies are an emerging area of attention; industry is paying close attention to potential enforcement in biosimilar market.

Enforcement Legal Issues

FDA Guides On Adding Biosimilar Indications

Sponsors may submit supplemental applications for additional indications in advance so that approval will coincide with expiration of a reference product’s exclusivity or patent protection, new draft guidance states; agency targets six-month review of such supplements, rather than the 10 months provided under BsUFA II.

Biosimilars Regulation

Biosimilars: US FDA Proposes Streamlined Pathway For Indication Carve-Ins

Sponsors may submit supplemental applications for additional indications in advance so that approval will coincide with expiration of a reference product’s exclusivity or patent protection, new draft guidance states; agency targets six-month review of such supplements, rather than the 10 months provided under BsUFA II.

Biosimilars Intellectual Property
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