16th Summit on Biosimilars & Innovator Biologics

Sterne Kessler was pleased to sponsor the 16th Summit on Biosimilars & Innovator Biologics hosted by ACI from June 2 to 3, 2025. Director Chandrika Vira spoke during the “Mastering the BPCIA Landscape: Litigation, Damages, Pricing and Settlement Negotiation Strategies” session on June 2, 2025.

Session Overview

Key decisions at the Federal Circuit, District Court, and PTAB have transformed the BPCIA landscape. As such, a thorough understanding of how courts are interpreting reasonable royalties, lost profits, and post-judgment damages is critical for determining the best course of action to avoid costly litigation and associated penalties. Topics for discussion included:

• Examining lessons learned from the Humira biosimilars and exclusivities afforded under the BPCIA and IRA
• Breaking down the Regeneron litigation and the push to establish a biosimilar MDL
• Coordinating BPCIA litigation with parallel IPR/PGR petitions for maximum advantage
• Analyzing the legislative and regulatory framework
• Navigating anti-competitive agreements and regulatory hurdles impacting biosimilar market access
• Negotiating launch triggers and volume limitations to secure favourable settlements
• Understanding how courts are interpreting reasonable royalties, lost profits, and post judgment damages