Читать книгу Biologics, Biosimilars, and Biobetters - Группа авторов - Страница 82

The emerging markets typically have relatively low access to biologic medicines when compared with developed markets. Patients in these markets stand to gain the greatest increase in access as a result of biosimilar competition. This has caused emerging market health authorities to put significant effort into encouraging use of non‐original biologics (NOBs). NOBs are copy‐biologics that have not gone through a biosimilar pathway with strict regulatory scrutiny such as the EMA, FDA, or WHO biosimilar guidelines. They have been preferred in the emerging markets due to their early access and lower price relative to true biosimilars. NOB uptake has been significant, the market was worth US$2.1 billion in 2015 relative to US$1.1 billion globally for true biosimilars (IMS MIDAS, 2016). They equate to 18% of all biologic sales in Pharmerging markets (countries having low positions in the pharmaceutical market but having rapid pace of growth) and are growing at almost twice the speed. However, the biosimilar regulatory environment in the emerging markets is changing rapidly. There has been a marked push for increasing quality of copy biologic medicines but increasing access and affordability will continue be the top priorities for policy makers.²⁴