Hepatitis Foundation International Biosimilars Issue Brief

Abstract

Biosimilars are biological medical products highly similar to the original products manufactured by different pharmaceutical companies. Biosimilars inherit a critical role that addresses the growing need for mechanism-based drugs needed to treat diseases such as hepatitis, HIV and various cancers. In this issue brief, the developmental background, approval process, regulatory review and safety procedures and naming process will be discussed in detail. Benefits and cost to the patient population will also be examined, contrasting how biosimilars can be interchanged or substituted with other drugs to produce near identical health outcomes at affordable prices. Although biosimilar development appears promising, guidelines to proper labeling and surveillance of adverse effects are still being conducted. Patients tend to respond differently to drug therapies, making biosimilars the patient-specific treatment alternative. The Food and Drug Administration (FDA) continues to expand on its recommendations to improve regulation, safety precautions and transparency across all levels of health care for medical providers and their patients.