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2.5.1 Biologics in Nontraditional Biologic Disease Areas

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2015 was the year that two high‐profile classes of biologics had their first launches, the anti‐PCSK9 mAbs for hypercholesterolemia (Repatha® and Praluent®) and an antiIL‐5 mAb for severe asthma (Nucala®). These launches were particularly important because the indications they were approved for have seen either no biologics (hypercholesterolemia) or a single biologic (asthma‐Xolair®). Both diseases are highly prevalent and mainly treated by primary care physicians using widely available generics. Healthcare systems have not been accustomed to restructuring drug administration for these patients with biologics, let alone paying for them.16

However, it is important to consider that biologics entering nontraditional biologic disease areas may take longer to optimally position within the patient pathway. This is because primary care physicians and patients are not accustomed to prescribing and using biologics, respectively, so it may take longer to benefit from such innovation. Historic examples of slow initial uptake for drugs in this category can be seen in the case of Xolair® and Prolia®; however, both drugs have now surpassed US$1 billion in sales (DRG Company & Drugs, April 2016).17

Biologics, Biosimilars, and Biobetters

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