White PaperGenerics: Bridging the Regulatory Gap in Pharmerging and ASEAN Markets Exploring trends and policies influencing generics while navigating regulatory challengesWANG XUEYING SHERRY, Principal, Head of Commercial Regulatory Services WANG KAIYE, Consultant, Commercial Regulatory Services FREDERICK SIM, Consultant, Commerical Regulatory ServicesTable of contentsIntroduction 2Generics: Importance and market trends 2Policies and interventions 3Barriers 3Intellectual Property (IP) protection 3Bioequivalence (BE) assessment 5Country-specific considerations 5Conclusion and recommendations 7References 8About the authors 10 iqvia.com | 2The increasing and continued use of generics in both developed and developing economies signifies a global pivot towards more affordable healthcare solutions. Generic drugs are defined by the World Health Organization (WHO) as pharmaceuticals usually intended to be interchangeable with originator brand products, manufactured without a licence from the originator manufacturer, and marketed after the expiry of patents or other exclusive rights.1 Since their inception, generics have significantly contributed to enhancing treatment access and improving global health and patient outcomes while also affording significant cost savings for healthcare systems and patients alike without compromising on efficacy.2 The global generic market was valued at around USD 268 billion dollars in 2022. Generics accounted for more than 71.5% of the global pharmaceutical market share by volume in 2022, gradually rising from 68.7% in 2018.3 Both the total market size and market share of generics are expected to continue growing in view of rising healthcare expenditures and the paradoxical pressure on governments to keep healthcare costs low or affordable. Consequently, most countries have applied or adopted various national policies to improve the use of generic medicines.On the regulatory front, combined efforts by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) through the introduction of a common dossier framework and the harmonisation of technical requirements, as well as the implementation, adoption, or adaptation of said framework and guidelines by National Regulatory Agencies (NRAs), have led to significantly streamlined regulatory pathways and quickened market entry.This white paper endeavours to provide a comprehensive understanding of the generics landscape in developing economies, with a particular focus on pharmerging and Association of Southeast Asian Nations (ASEAN) markets.Generics: Importance and market trendsThe growth trajectory of generics in various markets around the world has been on a consistent upward trend. At present, generic medicines occupy a significant 60%–80% share of all pharmaceutical volume sales in major markets around the world,3 including the pharmerging and ASEAN markets (Figu...
