Summary of the Pathway for Biosimilars Act
BIOSIMILAR BIOLOGICAL PRODUCTS APPROVAL PROCESS
Sets forth the requirements for FDA approval of a biological product as biosimilar to a reference product and provides a period of exclusivity for reference products and exclusivity for the initial interchangeable biosimilar.
Find out more about the Pathway for Biosimilars Act
"The Affordable Biologics for Consumers Act of 2007", S. 1505, and the "Patient Protection and Innovative Biologic Medicines Act", H.R. 1956, both would develop a safe and effective process for the approval of follow-on versions of revolutionary biologic medicines. These two bills create pathways for less expensive versions of biologic drugs that maintain the current high patient safety and scientific standards.
Currently, patients can rely on the fact that any generic drug they take is the "same" as the brand name product, which has already been proven safe and effective. The "Patient Protection and Innovative Biologic Medicines Act," sponsored by Representatives Jay Inslee (D-WA), Gene Green (D-TX) and Tammy Baldwin (D-WI), and "The Affordable Biologics for Consumers Act of 2007," sponsored by Senators Judd Gregg (R-NH), Richard Burr (R-NC) and Tom Coburn (R-OK), both reflect the unique nature of ground-breaking biologic drugs and ensure that patients are not subjected to unproven and potentially unsafe products.
Find out more about S. 1505, & H.R. 1956
The "Access to Life-Saving Medicine Act", H.R. 1038, permits approval of prescription drugs that have not been tested and threatens patient safety.
Sponsored by Rep. Henry Waxman (D-CA), Senator Charles Schumer (D-NY) and Senator Hillary Clinton (D-NY), H.R. 1038 would allow the approval of products not independently proven to be safe and effective by allowing generic manufacturers to rely on clinical research originally submitted to the FDA to support approval of different products. Currently, patients can rely on the fact that any generic drug they take is identical to the brand name product, which has already been proven safe and effective.
The Waxman-Schumer-Clinton bill ignores the scientific fact that all biologics are different; one cannot be the same or identical to the other. By not requiring follow-on products to be tested, the Waxman bill effectively subjects patients to unproven and potentially unsafe products deemed only "comparable" to the proven product.
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