About the Conference
ACI’s Biosimilars & Innovator Biologics Summit connects you with top industry experts, regulators, and litigators to tackle IP disputes, regulatory hurdles, and market access strategies, providing practical solutions for navigating the evolving biosimilar and biologics landscapes.
Prepare to shape the next decade of biosimilars and biologics innovation in Boston, the world’s leading life sciences hub.
Biologics remain the fastest-growing therapeutic class, delivering groundbreaking treatments across immunology, oncology, and rare diseases. Biosimilars were introduced to improve patient access and reduce costs, yet market access hurdles, pricing challenges, and competitive pressures demand innovative commercial and legal strategies to drive broader adoption.
2025 marks a transformational year for both biosimilars and innovator biologics.
- IP and Litigation: The looming patent cliff, intensified BPCIA litigation, and increased use of Section 1782 actions are reshaping market entry and exclusivity strategies.
- Regulatory & Policy: The Supreme Court’s reconsideration of the Chevron Doctrine in Loper Bright Enterprises v. Raimondo could fundamentally alter FDA rulemaking, adding complexity to regulatory compliance.
- Market Access & Pricing: A second Trump administration is expected to bring deregulation, shifts in drug pricing policy, and changes to Medicare reimbursement that will significantly impact commercialization strategies.
- Commercial Strategies & Competition: With record FDA biosimilar approvals in 2024, industry stakeholders must assess evolving payer dynamics, formulary placement, and the ongoing battle over rebate walls, all of which will shape pricing and adoption.
With sweeping changes to policy, regulation, IP, and market access, this year’s summit is more critical than ever. Whether you represent a biosimilar manufacturer, innovator biologic company, law firm, or regulatory body, this is the premier forum to gain actionable insights on patent litigation, exclusivity strategies, pricing and reimbursement, regulatory shifts, and competitive dynamics shaping the industry.
Join us to navigate the future of biosimilars and innovator biologics—where IP, legal, regulatory, and commercial strategies will define the next wave of industry growth.