1 Executive summary
2 Research objectives and methodology
2.1 Objectives
2.2 Methodology
3 What’s been happening in the biosimilars market?
3.1 Key insights
3.2 Overview
3.3 The biosimilars market continues to make good progress, and the remaining issues are focused on a smaller number of uncertainties
3.4 Regulatory issues remain, with much of the debate now focused on interchangeability in the US
3.4.1 The EMA continues to refine a well-established, and highly respected framework
3.4.2 More progress in the US, but no sign of its stance on interchangeability
3.4.3 Events elsewhere suggest regulatory standards are rising, but still have some way to go before catching Europe and the US
3.5 Investment in clinical development activity continues to grow, with many programmes now coming to the end of late-stage testing
3.5.1 Biosimilar landscape by class
3.5.2 Biosimilar landscape by molecule
3.6 National policy continues to evolve, with several countries now openly supporting biosimilar switching
3.7 Litigation remains a key offensive and defensive strategy for companies involved in the biosimilars market, but results have been mixed
3.8 The commercial story is beginning to unfold, with investments in infrastructure, portfolios and partnerships focused on driving biosimilar adoption
4 What are the key issues being debated in the biosimilars market today?
4.1 Key insights
4.2 Attitudes toward biosimilars are improving, but more needs to be done to improve awareness and understanding
4.3 From a regulatory perspective, interchangeability is the key open question
4.4 Views on what drives biosimilar uptake, and what could slow it down, have crystalised in recent months
5 Where are things headed for the biosimilars market?
5.1 Key insights
5.2 Does the FDA have enough resources to review biosimilar applications?
5.3 What’s likely to happen with the FDA’s interchangeability guideline?
5.4 What level of clinical data will be needed to support biosimilar applications in the future?
5.5 How will the markets respond to having multiple biosimilars of the same molecule available?
5.6 What could be the impact of national and local initiatives on biosimilar adoption rates?
5.7 Will the lawyers have the last laugh?
5.8 What are the critical commercialisation levers that need to be pulled?
5.9 What about future target selection?
5.10 Which companies will be present at the end of the biosimilars market’s second decade?
5.11 Is there a sense of optimism about the future of the biosimilars market?
6 Concluding remarks
7 Appendix
7.1 Biologic sales data
7.2 Expert biographies