The Association for Accessible Medicines (AAM) published a white paper addressing generic and biosimilar drug shortages and supply chain challenges in the US.
Generic drugs are crucial to the prescription drug market, making up more than 90% of all small molecule prescriptions. Though generics remained stable during the COVID-19 pandemic, shortages affected around 3% of brand-only markets and 4% to 6% of generic/brand and generic-only markets. The paper emphasized distinguishing drug shortages from out-of-stock situations, which have different causes and solutions.
The risk of drug shortages is rising due to challenges in generic manufacturing sustainability, including low return on investment, market consolidation, slow adoption of newer generics, and regulatory complexities. The paper outlined various factors leading to drug shortages and proposed solutions to ensure a sustainable generic drug market. These solutions involve speeding up new generics' market entry, encouraging the use of generics and biosimilars in Medicare drug plans, amending the 340B program, and addressing regulatory challenges.
Full article from AJMC here.