16th Summit on Biosimilars & Innovator Biologics

Sterne Kessler is pleased to sponsor the upcoming 16th Summit on Biosimilars & Innovator Biologics hosted by ACI from June 2 to 3, 2025. Director Chandrika Vira will be a speaker 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 include:

• 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