AAM All Access Podcast - Dan Leonard speaks with Mary Beth Powers, President and CEO of CMMB.

Biosimilars

Generic and Biosimilar Drugs Generate A Record $373 Billion For America’s Patients and Healthcare System in 2021

Despite Savings from Generic Drugs, Many Patients Continue to Pay More than Necessary

WASHINGTON, DC (September 21, 2022) — Today, the Association for Accessible Medicines (AAM), the leading trade association for generic and biosimilar manufacturers, released its 2022 U.S. Generic & Biosimilar Medicines Savings Report highlighting the value of generic and biosimilar medicines.

The Evidence Is Clear: Biosimilar Competition Will Achieve More Savings for Patients Than Build Back Better’s Negotiations

The biosimilars industry is proving that market competition works to drive down drug costs and increase patient access to medicines. According to IQVIA, savings from biosimilars increased over 800% from 2018 to 2020, from under $900M in 2018 to $7.9B in 20201,2. This is the result of new biosimilar launches and robust competition under which multiple biosimilar drug manufacturers win market share based on lower prices.

Proposed BBB Negotiation Framework Discourages Biosimilar Competition, Imposes Higher Costs on Commercially Insured Patients and Their Employers

In 2021, employers experienced a 6.3% jump in health benefit costs.1 Findings such as these, paired with high brand-name drug costs, are why commercial and employer-sponsored health plans have long looked forward to savings from biosimilar competition. Unfortunately, employers soon will be facing higher costs, if provisions in the Build Back Better Act (BBB) that discourage biosimilar development are adopted by Congress.

GDUFA and BsUFA User Fees

What are GDUFA and BsUFA user fees? Watch this this video to learn more about how the Generic Drug User Fee Amendments (GDUFA) and Biosimilar User Fee Act (BsUFA) help to get more generic and biosimilar medicines to patients more quickly. Over ten years, the generic and biosimilar industry has provided the FDA over $4 billion for review and approval of lower-cost treatments for America’s patients. The result is more than $2 trillion in savings to patients and a dramatic increase in patient access to life-saving treatments.

 

HHS OIG Report Demonstrates Need for Changes to Part D to Increase Biosimilar Use

Biosimilars provide more options for care at a lower cost for patients, but due to Medicare’s perverse incentives, many PBMs and health plans have been slow to prioritize biosimilars, leavings savings on the table. Last week, the HHS Inspector General (OIG) released an important analysis that drives home just how poorly Medicare plans are doing when it comes to making FDA-approved biosimilars available to America’s seniors.

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