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Statement by Ralph G. Neas, President and CEO, GPhA, Regarding the FDA Oncologic Drugs Advisory Committee Meeting on Biosimilar Approval for Filgrastim

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Steve Arnoff

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UPDATE January 7, 2014 5:00 p.m.

Statement by Ralph G. Neas, President and CEO, GPhA:

“GPhA is pleased that the FDA ODAC has voted unanimously to recommend that the FDA approve filgrastim, a Sandoz biosimilar under agency review, for each of the five indications in the application. This encouraging step forward means that it is very likely now only a question of when, rather than if, filgrastim will be available for patients in the United States. GPhA will continue to work with our regulatory partners at FDA to ensure the introduction of biosimilars in the United States. Among the next steps is the guidance on biosimilar naming and interchangeability.

Importantly, a departure from the currently accepted international nonproprietary name (INN) system could disrupt experts' ability to track and dispense these medicines, risking provider confusion and elevating the likelihood for mistakes. GPhA and more than 30 health organizations agree that it is critical to preserve the system already proven to be safe and effective in Europe and other markets.

This meeting is yet another significant stride toward ushering in the next frontier of more affordable medicine. We look forward to the day when millions of Americans can choose safe, effective and more affordable biosimilar therapies.”

 

WASHINGTON, DC (January 7, 2015) —  “Today’s Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) meeting features a strong showing of science-based support for biosimilar medicines from patients, pharmacists, generic drug manufacturers and other healthstakeholders, and is an important step forward for cancer patients and all who are awaiting access to more affordable versions of lifesaving biologic medicines here in the United States.

The meeting on filgrastim, a Sandoz biosimilar under agency review, is historic not only for FDA as it considers the first approval of a biosimilar product but also for patients in America awaiting access to safe, affordable versions of biologics. Biologic medicines are often the only lifesaving treatmentsavailable today for cancer, rheumatoid arthritis and some of the most severe diseases suffered by patients. However, the high cost of these treatments frequently keeps them out of reach. To promote competition in the biologics sector and make biosimilars available to patients, several GPhA member companies have developed, manufactured and are marketing biosimilars in Europe, Canada, Japan and other highly-regulated markets for many years. These manufacturers and others look forward to bringing these same life-saving biosimilar medicines to the United States.

By the time a biosimilar reaches a patient it will have undergone rigorous scientific and clinical tests and the FDA will have determined that the medicine is ‘highly similar’ and has ‘no clinically meaningful differences’ from the reference product.Americans can be assured they will receive a biosimilar medicine that is proven as safe and effective as the innovatorbiologic, but at a fraction of the cost.

That is why 10 organizations representing consumers, payers, purchasers, pharmacy benefit managers, pharmacists, managed care pharmacists, retail pharmacies, and others have written the FDA Oncologic Drug Advisory Committee to support the FDA's deep commitment to patient safety and applaud this open, transparent process.

These groups agree that American patients should have access to biosimilars and interchangeable biologics as intended by the Biologics Price Competition and Innovation Act (BPCIA) as have been available to patients in other highly regulated countries for years.

GPhA and its member companies applaud the FDA for advancing this process, bringing us another step closer to having biosimilars in the United States. We look forward to working with members of the supply chain, stakeholders and patients to expedite access to safe, effective and more affordable biosimilars.”

Resources:
January 7, 2014 letter to FDA ODAC

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 86 percent of the prescriptions dispensed in the U.S. but consume just 27 percent of the total drug spending. Additional information is available at gphaonline.org. Follow us on twitter: @gpha.