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Sandoz Inc.

Division of Novartis AG

Latest From Sandoz Inc.

AbbVie's 'Unjustified' Humira Settlements Divide Market, Class Action Claims

First suit challenging biosimilar litigation settlements ratchets up pressure on AbbVie's "patent thicket" and licensing strategy.

BioPharmaceutical Biosimilars

Biosimilar Sponsors Say Pharmacokinetic Bridging Studies Should Be The Exception, Not The Norm

US FDA guidance runs risk of creating de facto requirement for bridging studies when a biosimilar applicant seeks to use comparative data involving a foreign reference product, Novartis says; IGBA, AAM urge agency adopt a ‘global comparator’ approach that would eliminate the need for clinical bridging studies between US and foreign reference biologics.

Biosimilars Biologics

Biosimilars: US FDA Asked To Clarify Thinking On Pediatric Studies, Indication Carve-Outs

Draft guidance raises questions about Pediatric Research Equity Act obligations of biosimilar applicants and reference product holders, comments say; industry seeks clarity on review of indications with unexpired exclusivity and requests allowances for situations where a biosimilar's dosage form or labeled conditions of use do not align exactly with those of the reference product.

Biosimilars Pediatrics

Mylan Launches Advair Generic Wixela At 70% Discount To GSK's Branded Drug List Price

Two weeks after the product's approval, Mylan finally has launched Wixela and revealed a big price cut for the asthma and COPD medicine over the brand; the actual savings for patients remains dependent on payer negotiations and other factors.

Generic Drugs Pricing Strategies
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