Robust clinical trials will ensure that biosimlars are safe and effective for patients

Washington, D.C. – The Alliance for Safe Biologic Medicines (ASBM), a national not-for-profit organization dedicated to ensuring patient safety and access to biologic medicines, welcomes the first steps from the U.S. Food and Drug Administration (FDA) to bring biosimilars on the market here in the United States. Specifically, their proposed user fee program for biosimilars, published in the Federal Register, recognizes the complexity and level of effort required to ensure patient safety.

“One of the FDA’s primary responsibilities is to ensure our nation’s drug supply is safe and effective and this first step to require robust clinical trials of biosimilar medicines demonstrates they’re taking their role seriously,” Alliance Chairman and Phoenix-based endocrinologist Dr. Richard Dolinar said.  “We look forward to working with the FDA as they develop the biosimilars pathway and will urge them to keep patients first, and protect the patient-doctor relationship throughout the process.”

“Over the past decade, biologic medicines have given the gift of hope and time to Americans diagnosed with cancer and other previously untreatable medical conditions.  The patient community welcomes biosimilar versions when we can ensure they are as safe and effective as their innovator counterparts,” stated Andrew Spiegel, the CEO of the Colon Cancer Alliance and Alliance for Safe Biologic Medicines Steering Committee member.  “The FDA’s proposed performance goals and procedures appear to address the unique challenges posed by all biologic medicines.”

In 2010, the U.S. Congress authorized the FDA to develop a pathway to approve biosimilars, which are the nonidentical copies of biologic medicines.  Biologics are advanced medicines made from living organisms that treat serious conditions like cancer.  The FDA’s proposed recommendations for a user fee program for biosimilar biological products for fiscal years (FYs) 2013 through 2017 represent the first step in outlining the biosimilars pathway.  To learn more about the issue, visit or email

About the Alliance for Safe Biologic Medicines
The Alliance for Safe Biologic Medicines (ASBM) is an organization composed of diverse healthcare groups and individuals from patients to physicians, innovative medical biotechnology companies, and others who are working together to ensure patient safety is at the forefront of the biosimilars policy discussion.  We serve as an authoritative resource center of information for the public, medical communities, the FDA and other state and federal policymakers during the implementation of the biosimilars pathway and beyond.


The Alliance for Safe Biologic Medicines provides factual information on biologic medications and advocates for policies that protect patient safety and ensure the accessibility of these products.  More information available at

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