Drug Fix: State Of The Generics Industry, US FDA Commissioner On Compassionate Use

What It Covers

Recorded February 27, 2026, Drug Fix covers the Association for Accessible Medicines annual conference with Dave Wallace and Matt Hobbs reporting on generics industry momentum, biosimilar regulatory streamlining, US manufacturing reshoring pressures, and FDA Commissioner Martin McCarry's controversial compassionate use comments raising political interference concerns.

Key Questions Answered

• •Generics industry positioning: The generics sector has shifted from defensive advocacy to offensive lobbying by aligning its cost-reduction message directly with the Trump administration's efficiency priorities. AAM CEO John Murphy's strategy includes targeting lawmakers with state-level employment arguments or policy-alignment pitches depending on political affiliation, producing measurable wins including tariff exemptions and PBM legislation.
• •Biosimilar development economics: FDA's October guidance eliminating the default requirement for clinical endpoint studies opens previously unviable biologic targets to biosimilar competition. The prior requirement for Phase III trials made many lower-volume biologics economically unfeasible. Developers should now audit their pipelines against the "biosimilar void" — biologics already off-patent with zero competition in development — identified in AAM's IQVIA study.
• •Biosimilar market consolidation: Expect near-term consolidation among biosimilar developers, per Biocon's Matt Eric at the AAM conference. Markets around adalimumab and ustekinumab already support nine to ten competing developers, which is unsustainable. Fewer developers per molecule may actually improve market viability, though high-value pipeline targets like upcoming blockbuster biologics will continue attracting overcrowded competition.
• •US manufacturing reshoring: Generics and small-cap biosimilar firms cannot match big pharma's multi-billion-dollar US manufacturing pledges, creating a competitive disadvantage in tariff negotiations. The sector's practical strategy involves identifying which APIs and finished dosage forms are feasible to produce domestically and pursuing government incentives for supply chain resilience rather than blanket reshoring commitments.
• •FDA compassionate use politicization: FDA Commissioner McCarry claimed he personally approved 100% of compassionate use requests, a statement HHS later clarified by noting he forwarded requests to appropriate review divisions. Historically, commissioners never handled these approvals — career staff in review divisions do. Sponsors should monitor whether lobbyists now target compassionate use pathways directly, given reports of political pressure influencing review decisions.