Biosimilars & Innovator Biologics

Be sure to join this engaging and interactive session as our panelists assess how landmark policy changes, FDA draft guidance on the use of AI to support regulatory decision-making, shifting IP strategies, global market pressures, and other regulatory updates are shaping the landscape. This session will provide a comprehensive breakdown of the past year’s most critical legal, regulatory, and commercial developments and explore what’s ahead for 2025 and beyond.

Topics of discussion will include:

• Examining the FDA’s plans to apply a risk-based credibility assessment framework to evaluate the use of AI models in support of regulatory decision-making
• Evaluating the impact of Medicare drug pricing negotiations, IRA policies, and the 2025 Trump Administration on biosimilar adoption and market access
• Assessing the Loper Bright Enterprises v. Raimondo decision and its impact on FDA authority, industry compliance, and regulatory interpretations
• Navigating evolving patent litigation and the increasing use of Section 1782 actions
• Exploring global harmonization efforts and the competitive landscape shaping adoption
• Predicting the future of biosimilars, biobetters, and next-gen biologics as competition intensifies post-patent cliff

Innovators that are concerned about biosimilar competition have to navigate even more financial risk under the ongoing price control provisions of the IRA and the possible expansion of march-in rights. This landscape not only challenges the innovator biologics community — but also offers an opportunity for biosimilar makers to strategize and capitalize on these changes. Join us as we discuss these legal, regulatory and commercial challenges, along with strategies to overcome these issues. Topics for discussion include:

• Developing next-generation biologics with improved efficacy or new indications
• Actively managing IP to extend exclusivity
• Engaging in robust clinical trials to solidify the safety and efficacy profile of the original drug
• Exploring new therapeutic areas with high unmet medical needs

The “safe harbor” provision in US patent law (35 U.S.C. § 271(e)(1)) protects certain activities, including those related to biosimilar development, from patent infringement lawsuits. This defense applies to acts that are “solely for uses reasonably related to the development and submission of information” to the FDA under regulations for drugs or biologics. A company’s subjective intent or alleged alternative purposes are irrelevant when determining whether the safe harbor applies. What matters is whether the act was for a use “reasonably related” to the development or submission of information to the FDA.

Join us in this discussion as we discuss recent Safe Harbor case law and critical elements of the Safe Harbor defense, such as:

• Determining what is and is not shielded by the safe harbor following Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. Ltd.
• Analyzing the broad interpretation of the term ‘solely’ for regulatory purposes and the implications for patent enforcement
• Exploring Biosimilars and Biologics perspectives on the scope of conduct covered by the safe harbor
• Examining where safe harbor defenses are sustained – and where they are being defeated
• Allele Biotechnology & Pharm v. Regeneron Pharm
• Protecting third party manufacturing activities for the purpose of filing for approvals

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

As the 2025 patent cliff reshapes the industry, both innovators and biosimilar manufacturers must adapt to evolving litigation, market access strategies, and payer dynamics. With new Medicare policies governing formulary placement for innovator biologics and biosimilars, PBMs playing a decisive role in formulary placement, and lessons from the IRA, companies are navigating an ever-changing and reimbursement landscape. Join us as we discuss:

• Understanding the evolving framework for coverage under Medicare Parts B and D
• Trends in commercial market coverage
• Enrollee uptake of biosimilars versus innovator biologics
• Decoding PBM formulary decisions and their impact on pricing, reimbursement, and market share

Biosimilar pricing, approvals, and regulatory oversight are entering a new era of uncertainty. Will policy shifts accelerate adoption, or will deregulation introduce new market complexities? As the administration rolls out executive orders and potential reforms, the industry must anticipate shifts in pricing, access, and oversight. Changes in the landscape regarding interchangeable biosimilars only compound this uncertainty. Join us for this critical discussion as we examine:

• Assessing the IRA’s future and its impact on pricing and competition
• Evaluating whether FDA will adopt a less-stringent review process under new leadership
• Exploring how the FDA may regulate biobetters and whether clearer pathways will emerge
• Examining recent changes in the FDA’s approach to interchangeable Biosimilars and the impact thereof
• Unpacking recent developments and current trends relating to interchangeable biosimilars and implications for the future