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.

    Related Conference of Legal Issues and BPCI Act

    September 19-20, 2025

    18th World Drug Delivery Summit

    Paris, France
    September 22-23, 2025

    Pharma Biotech Expo

    Toronto, Canada
    September 23-24, 2025

    10th International Conference on Future Pharma and Innovations

    Amsterdam, Netherlands
    September 24-25, 2025

    5th World Congress on Rare Diseases & Orphan Drugs

    Aix-en-Provence, France
    October 23-24, 2025

    21st Annual Meet on Pharmaceutical Sciences

    Paris, France
    November 11-12, 2025

    6th Annual Congress on Antibiotics and Bacterial Infections

    Amsterdam, Netherlands
    November 13-14, 2025

    21st International Conference on Pharmaceutical Chemistry

    Aix-en-Provence, France
    November 20-21, 2025

    21st Annual Congress on Pharmacology and Toxicology

    Paris, France
    November 27-28, 2025

    4th World Congress on Precision and Personalized Medicine

    Zurich, Switzerland
    November 27-28, 2025

    4th World Conference on Pharma Industry and Medical Devices

    Zurich, Switzerland
    December 01-02, 2025

    13th International Conference on Clinical Trials

    Vancouver, Canada
    February 23-24, 2026

    3rd World Congress on Biologics and Biosimilars

    London, Aland Islands
    March 23-24, 2026

    36th Annual European Pharma Congress

    London, UK
    April 16-17, 2026

    19th European Biosimilars Congress

    Rome, Italy
    April 27-28, 2026

    9th European Biopharma Congress

    Paris, Aland Islands
    May 28-29, 2026

    3rd International Conference on Pharmacognosy

    Madrid, Spain
    July 27-28, 2026

    39th World Congress on Pharmacology

    Rome, Italy

    Legal Issues and BPCI Act Conference Speakers

      Recommended Sessions

      Related Journals

      Are you interested in