There is a compelling need for the US Congress to back new legislation
to create a Food and Drug Administration approval pathway for generic versions of biotechnology drugs (biogenerics), according to Kathleen Jaeger, president of the Generic Pharmaceutical Association.
“Biopharmaceutical products are expensive, and generic versions of brand biopharmaceutical products can, and will, offer consumers billions of dollars in savings,” she told the GPhA’s annual meeting on March 2.
The approval pathway created by the Access to Life-Saving Medicines Act
would give the FDA “the authority and flexibility it needs to ensure safety and efficacy, as well as more timely access to affordable biogenerics,” Ms Jaeger told the meeting. It would apply the most advanced scientific methods and, as with branded products, defer to the FDA’s scientific judgement on appropriate approval requirements on a product-by-product basis, she added.
Next step or lack of evidence?
The Pharmaceutical Care Management Association, which represents
pharmacy benefit managers, calls the bill the “next step” toward increasing access and reducing drug costs for consumers and employers. The PCMA also estimates, “conservatively,” that it could save the Medicare prescription drug programme $14 billion over the next 14 years. However this forecast, and another by leading PBM Express Scripts that biogenerics could save US patients and health plan sponsors $71 billion over 10 years, have been attacked by the Biotechnology Industry Organization as containing “numerous flawed assumptions” and a “lack of credible evidence.”
Both studies’ assumption that follow-on products will be promptly rated as interchangeable by the FDA and that market substitution will therefore occur rapidly, ignores existing regulatory, scientific and market experience, says the BIO, which also points out that, in fact, the FDA has not determined how interchangeability can be established for complex proteins.
“No credible analysis of follow-on biologics suggests that we will see anything close to the savings we’ve seen from generic drugs, nor any savings close to the flawed estimates claimed in these studies,” said Ted Buckley, BIO’s director of economic policy. “As leading health economists have pointed out, the traditional generic drug business model is simply inapplicable when dealing with these complex biological products.”
Moreover, the degree to which regulatory approval is sought is likely to depend on “an intense legislative debate” on reauthorisation of the Prescription Drug User Fee Act, which expires September 30, says a recent paper by attorneys at Washington law firm Alston and Bird. Several of the Act’s sponsors plan to attach it to the PDUFA reauthorisation bill but, say the lawyers, branded drugmakers emphasise that generic biologics will never be the “same” as the already-approved products, in the generic sense.
Meantime, congressional examination of biogenerics is set to continue this week, with a full hearing of the Senate Health, Education, Labor and Pensions Committee, chaired by Democrat Edward Kennedy, on the issue this Thursday (March 8).
– The Access to Life Saving Medicine Act of 2007 is sponsored in the Senate by Democrats Charles Schumer and Hillary Rodham Clinton, and Republicans David Vitter and Susan Collins, and in the House by Representatives Henry Waxman (Democrat) and Jo Ann Emerson (Republican). By Lynne Taylor