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In a proof-of-concept study, researchers from the University of Colorado Anschutz Medical Campus evaluated a subset of participants enrolled in the ongoing RESTORE clinical trial

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What Biosimilar Launch Timing Actually Depends On in a CIP-Heavy Patent Landscape Biosimilar launch timing in a CIP-heavy patent landscape is determined by three factors operating in sequence: the settlement negotiations between the innovator and the biosimilar developer, the results of any litigation on patents the parties cannot resolve by agreement, and the regulatory exclusivity periods 12 years for reference biologics under the BPCIA that run independently of patent status

Grauslund J, Taha AA, Molander LD, Kawasaki R, Mller S, Hjlund K, Stokholm L