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Sandoz Inc.

Division of Novartis AG

Latest From Sandoz Inc.

The Quality Lowdown: Novartis/Sandoz Child-Resistant Packaging; Solvent Testing; Quality Metrics; Cell And Gene Therapy

Why did Novartis/Sandoz’s hospital blister packs have to be child-resistant? Why did two warning letters to Chinese firms follow promises of more, better testing? And should firms should consider volunteering for new FDA quality metrics programs (or not) and a pre-competitive industry collaboration on cell and gene therapies?

Manufacturing Quality

Interchangeability Comments From Biosimilar Sponsors Highlight Need For Flexibility, Challenges Of Postmarket Data Collection

As US FDA mulls how to make demonstrating interchangeability less burdensome, worries about the now-withdrawn guidance from biosimilar developers may offer some guideposts about where the agency will go.
Biosimilars Drug Approval Standards

Biosimilar Substitution: US State Laws Require Physician Communication And, In Some Cases, Lower Prices

Bills allowing pharmacies to substitute biosimilars for reference biologics have been enacted in all but six states. Interactive map notes state-by-state provisions.

Biosimilars State News

Mylan's Fulphila Approval: Lack Of US FDA AdComm May Be A Positive For Biosimilar Industry

The advisory committee route for approving a first biosimilar to a reference product is no longer necessarily the norm, going by FDA's recent approval of Mylan/Biocon's pegfilgrastim-jmdb, which references Amgen’s Neulasta; agency’s view that a meeting was not needed should encourage other biosimilar aspirants.

Biosimilars Advisory Committees
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