Division of Novartis AG
Latest From Sandoz Inc.
First suit challenging biosimilar litigation settlements ratchets up pressure on AbbVie's "patent thicket" and licensing strategy.
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.
Draft guidance raises questions about Pediatric Research Equity Act obligations of biosimilar applicants and reference product holders, comments say; industry seeks clarity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.
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.
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Greg Nulty, VP, Head, Finance & CFO
Patrick Genestin, VP, Bus. Dev. & Licensing
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Anthony Maffia, III, VP, Regulatory Affairs
Carol Lynch, Pres.
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