AAM to Congress: Pass key bills considered by the Senate HELP Committee

On the anniversary of the enactment of the Hatch-Waxman Act forty years ago, the Association for Accessible Medicines and its Biosimilars Council on Tuesday commended the slated mark up by the Senate Health, Education, Labor and Pensions Committee of two important pieces of legislation—the Biosimilar Red Tape Elimination Act and the Medication Affordability and Patent Integrity Act. AAM urges Congress to swiftly pass both pieces of legislation.

“Forty years ago today, the Hatch-Waxman Act ushered in trillions in savings for patients through generic medicines,” said David Gaugh, interim president and CEO of AAM. “AAM commends the Senate HELP Committee for continuing work to bring generic medicines and biosimilars to patients. These two bills will help ensure generic and biosimilar savings for the next 40 years.”

The Biosimilar Red Tape Elimination Act is consistent with the FDA’s recommendation to remove the statutory distinction between biosimilars and interchangeable biologics. This distinction, which is not based on any scientific differences between the products, has resulted in brand misinformation, patient and provider confusion and ultimately, hindered biosimilar adoption. Of note, FDA has emphasized that there is no scientific difference between biosimilars and interchangeable biologics through numerous educational offerings for providers and patients, including a recent article published in JAMA. No other country in the world uses this arbitrary designation, AAM said.

[Read more: AAM report: Generics, biosimilars generate $445B in savings]

The Medication Affordability and Patent Integrity Act would require the sponsor of any application, including any drug or biologic application, to certify to both the FDA and PTO that information submitted to each agency is consistent with information submitted to the other. This clarification will help address gaming of the patent system by brand drug manufacturers.