Brand Efforts Seek to Limit Patient Access to Biosimilars

Monday February 4, 2019

Actions by branded companies to undermine proven safe, effective biosimilars hurt patients. U.S. Food & Drug Administration Commissioner Scott Gottlieb shares his concerns in the Washington Post:

“I am worried that there are either deliberate or unintentional efforts by branded companies to create confusion” about the safety and effectiveness of unbranded biologic drugs, FDA Commissioner Scott Gottlieb said in an interview with The Washington Post. The messages “can potentially undermine consumer confidence in biosimilars in ways that are untrue.’’

Gottlieb did not name specific companies or groups. But an alliance of makers of the highly profitable advanced drug therapies issued some of the most glaring warnings about government-approved copies of their products: They could “put you in the emergency room.’’ They may carry “additional risks.’’ The “potential problems involve efficacy, safety.’’

Gottlieb indicated the FDA may take action if it determines a company is deliberately misleading the public about the safety of biologic copies, by issuing warning letters to the drugmakers involved.

Such messages about unbranded biologics “raise public health concerns,’’ he said. “They could negatively impact a patient’s judgment about an otherwise safe and effective product.’’

At stake are savings to the U.S. health-care system that have been estimated at $54 billion to more than $200 billion over 10 years.”


About the Biosimilars Council

The Biosimilars Council, a division of the Association for Accessible Medicines (AAM), works to ensure a positive environment for patient access to biosimilar medicines. The Biosimilars Council is a leading source for information about the safety and efficacy of more affordable alternatives to costly brand biologic medicines. Areas of focus include public and health expert education, strategic partnerships, government affairs, legal affairs and regulatory policy. More information is available on our about page.

About AAM

AAM is driven by the belief that access to safe, quality, effective medicine has a tremendous impact on a person’s life and the world around them. Generic and biosimilar medicines improve people’s lives, improving society and the economy in turn. AAM represents the manufacturers and distributors of finished generic pharmaceuticals and biosimilars, manufacturers and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. Generic pharmaceuticals are 90 percent of prescriptions dispensed in the U.S. but only 23 percent of total drug spending. Additional information is available at

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