Generic medicines are essential to improving patient access to important drug therapies. They account for approximately 90% of prescriptions filled in the United States, contribute to lower prescription drug costs and help save trillions of dollars. For some patients, the availability of generics may determine whether they can access and afford treatment.
Complex generics are a growing category of products that are characterized by complex active ingredients, formulations or routes of delivery. Examples include inhalers, injectables, ophthalmic solutions and suspensions and transdermal patches. Patients rely on complex generic drug products for many indications, including chronic conditions such as diabetes and asthma.
Due to their complexity, generic versions of these drug products can be difficult to develop, so they are less likely to be available than other generics. These products also may be significantly more prone to drug shortages from supply, demand and regulatory issues. For patients, that can mean less access to medicines they need. USP is working with stakeholders across the medicines supply chain to understand the scientific and regulatory issues associated with complex generics to reduce barriers to their development and assessment, making them more accessible to the patients who need them.