Global Scans · Pharmaceuticals · Weekly Summary

• [New] Instead of ~8 years, a biosimilar might reach approval in ~5-6 years. Mabion S.A.
• [New] Niazi's biosimilar application for Stelara will be the first filed with the FDA that does not require any clinical testing, marking a precedent-setting regulatory breakthrough. Pharmacy Times
• [New] Pharmaceutical firm Sanofi in Paris suggests that the acne vaccine it is developing could yield more than $2 billion per year in revenue. Scientific American
• [New] Sanofi has 12 new drug candidates, including Amlitelimab and Frexalimab, as next-generation drugs and aims to achieve annual sales of more than €1 billion by 2030. ABITA LLC&MARKETING JAPAN
• [New] If a new blockbuster drug that surpasses Dupixent becomes a reality, it could change the world's medical map by 2030. ABITA LLC&MARKETING JAPAN
• The recently created Strategic API Reserve, in conjunction with Trump administration domestic manufacturing policies and pharmaceutical tariffs, is expected to incentivize domestic manufacturing and spur investments by strategic acquirers and private equity investors. / USA Debevoise
• President Trump recently stated that pharmaceutical tariffs could reach 250%. Debevoise
• Investor interest in domestic pharmaceutical manufacturing is expected to increase based on the Trump administration's recent steps to reduce the United States' reliance on foreign sources of finished drug products and active pharmaceutical ingredients (APIs). Debevoise
• The imposition of pharma-specific tariffs by the US will impact American access to affordable medicines and will cause ripples across global pharmaceutical supply chains. OBSERVER RESEARCH FOUNDATION ( ORF )
• Using machine learning, MIT chemical engineers have created a computational model that can predict how well any given molecule will dissolve in an organic solvent - a key step in the synthesis of nearly any pharmaceutical. MIT News | Massachusetts Institute of Technology

Last updated: 09 September 2025