Biological Products & Biosimilars

The 2025-2028 Draft Action Plan for Addressing Shortages of Medical Products and Critical Foods and Strengthening the Resilience of Medical Product and Critical Food Supply Chains (“Draft Action Plan”) presents coordinated and strategic actions that the Department of Health and Human Services (“HHS,” or “Department”) plans to take from 2025 through 2028.

Biosimilars provide competition for biologics, which account for a significant and growing portion of Medicare Part B drug spending. This report evaluates the current state of biosimilar competition in Medicare Part B and explores opportunities to achieve further savings.

The U.S. supply chain for provider-administered outpatient drugs involves several entities, including drug manufacturers, wholesalers, healthcare providers (e.g., outpatient facilities, hospital pharmacies, doctor’s offices, and standalone clinics), group purchasing organizations (GPOs), payers, and beneficiaries.

The ASPE issue brief examines the research and development cost and duration associated with bringing novel vaccines to the U.S. market. The results indicate that bringing a novel vaccine to the U.S. market costs an estimated $886.8 million on average, and its development process lasts 10 years.

Medical product shortages are an ongoing public health concern, with at least 140 products in shortage as of July 2024.We use the Household Pulse Survey to examine how many adults are affected by shortages of critical medical products in the United States.In fall 2023, shortages of medical products impacted about 38.8 million (18 percent) of individuals in the United Stat

The cornerstone of a well-functioning market is competition. President Biden’s Executive Order 14036, “Promoting Competition in the American Economy” identified a lack of competition as a key driver for problems across economic sectors.

The U.S. Department of Health and Human Services (HHS), Office of the Assistant Secretary for Planning and Evaluation (ASPE) released new research on spending and utilization trends of Medicare Part B drugs, drugs administered in physicians' office or hospital outpatient departments rather than being purchased at the pharmacy counter or by mail order.

High prescription drug costs are a leading concern among Americans. Americans pay higher prices for prescription drugs than any other country in the world, with prescription drug prices in the U.S. more than 2.5 times as high as those in other similar high-income nations.

This study presents the findings of a national survey of physicians about their knowledge of biosimilar biological products as well as the impact of biological product naming conventions on prescriber choice. Related Products