Legal Issues and BPCI Act

Legal issues surrounding biosimilars revolve around intellectual property rights, patent disputes, and regulatory frameworks. The Biologics Price Competition and Innovation (BPCI) Act, enacted in the United States, created a pathway for the approval and market entry of biosimilars. However, legal challenges arise from patent litigation initiated by reference biologic manufacturers to protect their exclusivity. These disputes can delay the launch of biosimilars and extend market exclusivity for reference products. The BPCI Act also addresses the interchangeability of biosimilars, providing a framework for automatic substitution at the pharmacy level. However, state-specific laws and regulations can introduce further legal complexities. Navigating these legal issues requires a thorough understanding of intellectual property laws, regulatory guidelines, and litigation strategies to ensure fair market competition and patient access to affordable biosimilars.

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