Biosimilars Needed For More Competition In High-Cost Drug Marketplace

by Courtney Jay

September 17, 2015

Competition drives value for consumers. That’s why biosimilars, clinically similar but less expensive versions of FDA-approved biologic medications, are an important new tool fostering more bang for consumers’ buck. These tools are especially helpful for patients facing diagnoses with expensive treatment regimens like cancer or various auto-immune diseases.

The FDA is currently in discussions with manufacturers regarding 47 biosimilar products under development. With an increasing number of biosimilars with potential to enter the market, an effort is underway to implement a naming policy and coding systems for the new drugs. The new naming system should reflect the agency’s commitment to patient safety while not discouraging patient access to these cost-saving therapies.

The Centers for Medicare and Medicaid Services proposed a coding and reimbursement system under Medicare that will distinguish the various biosimilars from their brand-name counterparts and group them under the same billing code, setting the sales price of the group of drugs at the weighted average of all drugs under that code. This policy has the potential to provide lower cost biosimilars to Medicare beneficiaries. Another plus – the new coding system better tracks the safety and effectiveness of these biosimilars for patients.

AHIP, as well as the congressional advisory agency MedPAC, view these as steps in the right direction for increasing accessibility to these lower-cost options and promoting long-term price competition in the marketplace.

Today, FDA Director of the Center for Drug Evaluation and Research Janet Woodcock gave a progress report on biosimilar implementation to the Senate Subcommittee on Primary Health and Retirement Security. Check out video of her testimony.