Statement by Chip Davis President and CEO GPhA Regarding BsUFA Reauthorization

Article

The Biosimilars Council, a division of the Generic Pharmaceutical Association, is pleased that the Food and Drug Administration is hosting a constructive dialogue on the processes and recommendations for the next Biosimilar User Fee Act.

Press Release

WASHINGTON, DC (Dec. 18, 2015) — "The Biosimilars Council, a division of the Generic Pharmaceutical Association (GPhA), is pleased that the Food and Drug Administration (FDA) is hosting a constructive dialogue on the processes and recommendations for the next Biosimilar User Fee Act (BsUFA).

As the biosimilars market in the United States is in its early stages, it is critical that policies established promote competition and create opportunities to speed patient access to safe, effective alternatives to costly brand biologic drugs.

While the FDA has set a promising foundation, fewer biosimilars are approved today than the agency projected. One important step that can be taken to expedite access to these alternatives to costly brand biologic therapies is to codify the currently outstanding biosimilars regulations. Further, FDA must have the resources it requires to provide timely detailed feedback to manufacturers during the application process.

More collaborative independent public information and education efforts can better inform patients and professionals about biosimilar safety and scientific development. That is why the Biosimilars Council efforts in 2016 will include opportunities for prescribers, providers and others to learn more about these vital medicines.

Moving forward, it is critical for FDA and industry to collaborate and focus negotiations on efforts that promote access to more affordable, high quality biosimiliars for the patients who rely on these essential medicines.”

View the Biosimilars Council presentation slides here.

About GPhA

GPhA represents the manufacturers and distributors of finished generic pharmaceuticals, manufacturers and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. Generic pharmaceuticals fill 88 percent of the prescriptions dispensed in the U.S. but consume just 28 percent of the total drug spending. Additional information is available at gphaonline.org. Follow us on twitter: @gpha.

About the Biosimilars Council

The Biosimilars Council, a division of the Generic Pharmaceutical Association (GPhA), 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 at www.biosimilarscouncil.org.

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