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Because there is no 180-day exclusivity for the first biosimilar (only a separate, limited exclusivity for the first interchangeable biosimilar, and only against other interchangeables), the first-mover advantage that drives Paragraph IV filings in small molecules does not exist for biosimilars

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Even the FDA acknowledged that "patients and prescribers may still see intermittent and limited localized supply disruptions as the products move through the supply chain from the manufacturer and distributors to local pharmacies." The American Society of Health-System Pharmacists' shortage list continues to show both semaglutide and tirzepatide injection in shortage

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