慧眼识局：进入欧美仿制药市场的成功策略.pdf

Generics API Manufacturing: Successful Market Entry Strategies for US Europe Mike Chace-Ortiz Senior Director, Generics Thomson Reuters Life Sciences June 2016 THOMSON REUTERS GENERICS INTELLIGENCE • 20 years of experience in global generic markets • Unique research that tracks global generic API development and manufacturing activities • Intelligence appears in Newport Premium® used by professionals in: – Strategy, Planning and Product Targeting – Business Development Licensing – Competitive Business Intelligence – API Sourcing Specialists – Patents Intellectual Property • Supports Life Sciences consulting projects • Serves 400+ customers operating in 80 countries • Team based in Portland, Maine, USA © 2016 2 The Keys to Success • Understand the market • Understand the regulations • Target the right products, as early as possible • Understand the competitive environment • Identify the right partners • Continually track progress as conditions change © 2016 3 US GENERIC MARKET 4 Current Environment • Specialty, biosimilar, and orphan drugs will be the fastest growing • $85billion in current sales will be exposed to generics (2016 to 2020) • Fewer exclusivity periods, fewer small molecule opportunities • Generic volume share continues to rise • ANDA backlog has been reduced significantly with the hopes of reducing review times that were once 40 months down to approx 10 months – ANDAs PASs with “first action” are 84% 88% respectively • Growth through acquisition (technology, capacity, portfolio) • Increasing regulatory burdens, supply chain controls • Significant generic user fees • Mutual recognized GMP ins