biologics exclusivity

Biologics exclusivity is a legal period during which a brand-name biologic drug has exclusive rights to market itself without generic or biosimilar versions entering the market. This period encourages innovation by allowing the original manufacturer to recover research investments. After exclusivity ends, other companies can develop similar versions, promoting competition and potentially lowering prices. In the U.S., a biologic's exclusivity typically lasts 12 years from the approval date. This system balances encouraging innovation with eventually enabling more affordable options for patients through competition.