Research & DevelopmentBiologics & Biosimilars

Biologics are medicines made from living cells through highly complex manufacturing processes and must be handled and administered under carefully monitored conditions. Biologics are used to prevent, treat, diagnose, or cure a variety of diseases including cancer, chronic kidney disease, autoimmune disorders, and infectious diseases. A biosimilar is exactly what its name implies — it is a biologic that is “similar” to another biologic drug already approved by the FDA. Under U.S. law, a biosimilar is approved based on a showing that it is “highly similar” to an FDA-approved biological product, known as a reference product. It may not have any clinically meaningful differences in terms of safety and effectiveness from the reference product.

In 2010, Congress approved the Biologics Price Competition and Innovation Act (BPCIA), creating an abbreviated approval pathway for biosimilars, while maintaining incentives for continued medical advances. To achieve the balance between increased competition among biologics from biosimilar products with the need for incentives to support future medical innovations, Congress provided biopharmaceutical innovators with 12 years of data protection for biologic medicines. To date, the FDA has issued several draft and final guidance documents to assist biosimilar sponsors in generating data to support biosimilar applications. FDA guidance and regulations provide insight into the agency’s current thinking regarding how it will evaluate biosimilar biological products. The FDA approved in March 2015, the first biosimilar product for marketing in the United States.

Data Protection

Data protection, sometimes referred to as data exclusivity, prohibits third parties, e.g., other manufacturers, from using or relying upon the extensive data generated through clinical trials and other research to obtain FDA approval for their product for a set period of time. Providing innovators with data protection recognizes the substantial time, costs, and scientific and regulatory uncertainty related to the R&D process for medicines and the significant investment required to develop the data needed for FDA approval. Data protection allows a biologic to be on the market for a set period before a biosimilar application can be approved based on the innovator’s data and protects against the uncertainties caused by patent challenges early in a product’s life.

Access to Biosimilars

For Medicare and other health insurance programs to ensure that reimbursement claims are processed in an orderly and consistent manner, standardized coding systems are essential. CMS developed the Healthcare Common Procedure Coding System (HCPCS) to facilitate timely and accurate processing of reimbursement claims. The Affordable Care Act created a novel and carefully balanced formula for reimbursing biosimilars compared to innovator biologics in Medicare Part B. To enable effective pharmacogilivance, support appropriate patient care, and facilitate reimbursement, CMS should provide for a separate HCPCS billing code and reimbursement for each biosimilar biologic product.