Biosimilars

• Discuss the current state of biosimilars as a unique category of therapeutics
• Highlight the gaps in understanding and evaluating biosimilars from an HEOR lens
• Propose solutions to issues pertaining to biosimilar accessibility, adoption, utilization, value, and impact

Biologic drugs, also defined as large molecules (proteins, nucleic acids, and sugars that undergo production through complex and lengthy biotechnological processes), have established themselves as critical therapies that have changed the course of disease for many life-threatening conditions and those impacting patients’ quality of life. Examples include chronic diseases such as inflammatory bowel disease, rheumatoid arthritis, and various forms of cancer.  They also contribute significantly to the overall drug expenditure in most healthcare systems, however. For example, the average daily cost of a biologic in the US is $45 when compared with a chemical drug that costs only $2. Thus, the financial burden of reimbursing patent protected biologics for all eligible patients may not be affordable, especially for low or middle-income countries.

The United States’ Food and Drug Administration (FDA) has defined a biosimilar as “a biologic product that is highly similar to the reference product, notwithstanding minor differences in clinically-inactive components, and for which there are no clinically meaningful differences between the biologic product and the innovator product in terms of safety, purity and efficacy.” Biosimilars offer an opportunity for improving access to high-priced biologic therapies, particularly for patient groups that had limited availability of the originator biologic due to cost constraints. Despite the availability of biosimilars, challenges in their value assessment and barriers in policy and clinical decision making may limit their widespread use.