AI Summary
→ WHAT IT COVERS Generics Bulletin editors report from two February 2026 industry conferences — AAM's Access meeting in Miami and Medicines for Europe's regulatory conference in Amsterdam — covering biosimilar streamlining, EU pharma legislation reform, tariffs, and PBM accountability across global off-patent markets. → KEY INSIGHTS - **EU Pharma Legislation Timeline:** The EU's first regulatory framework overhaul in 20 years enters formal adoption in Q2 2026, with provisions taking effect summer 2026 but full implementation deferred until summer 2028. Companies should begin auditing internal processes now, as compliance will require significant time and investment. - **FDA Biosimilar Streamlining:** Two recent FDA guidances remove the default requirement for comparative efficacy studies and ease use of non-US reference products, eliminating costly bridging studies. This materially lowers biosimilar development costs and shifts the commercial threshold for which products are viable to pursue. - **PBM Reform Momentum:** The FTC settlement with Express Scripts and emerging US legislative transparency measures signal incremental progress on middleman pricing practices. The high-WAC/high-rebate biosimilar pricing strategy is losing traction, suggesting companies should reassess rebate-based commercial models in favor of net-price approaches. - **Digitalization as Regulatory Priority:** Europe's push for standardized digital data and document sharing across member states is reshaping the regulatory affairs profession. Companies cannot wait for slower member states to catch up — internal IT investment in regulated departments and upskilling RA teams in digital processes is now operationally necessary. → NOTABLE MOMENT Despite being a US-focused conference, multiple AAM attendees proactively asked about European regulatory developments — signaling that biosimilar streamlining and supply chain resilience are now genuinely global strategic priorities, not region-specific concerns. 💼 SPONSORS None detected 🏷️ Biosimilar Regulation, EU Pharma Legislation, FDA Guidance, Generic Drug Policy