Tag: FDA exclusivity

Biologic Patent Protection: When Biosimilars Can Enter the U.S. Market

Biologic Patent Protection: When Biosimilars Can Enter the U.S. Market

Biosimilars in the U.S. face a 12-year exclusivity period before approval, delayed further by patent litigation and complex development costs. Unlike generics, they require massive investment and regulatory hurdles, leaving patients paying higher prices for years.