Asthma is a chronic inflammatory disorder of the airways affecting millions of people across the EU5 countries under study and representing a costly health expense for payers. Symptoms can often be controlled through the use of long-acting inhalers, with long-acting beta2 agonist/inhaled corticosteroid fixed-dose combinations (LABA/ICS FDCs) dominating the EU5 markets. Limited availability of true generic alternatives in the LABA/ICS FDC class, owing to patented delivery systems, has kept drug prices high; however, these agents face growing competition from generic/branded generic LABA/ICS FDCs and additional downward pricing pressure from payers, which together create a challenging market access environment for current and future inhaled therapies. High unmet need exists for severe, refractory asthma patients, for whom Xolair has been the only licensed biologic available since 2005. However, the entry of additional expensive biologics targeting this patient population will be met with increasing reimbursement restrictions and coverage limitations, particularly at a subnational level in some markets; the launch of a less-expensive omalizumab biosimilar could further change the dynamics of this market. Thus, drug makers must carefully navigate the road to reimbursement in order to optimize uptake.