NEJM calls for US Obama to encourage Congress to adopt exclusivity periods for biopharmaceuticals similar to those in Hatch-Waxman Act

US President Barack Obama should encourage amendments that would give the Food and Drug Administration the mandate to evaluate and approve 'biosimilar' drugs in a reasonable period, starting, as with small-molecule products, five years after the approval of the original drug. Such a compromise would best balance the need for financial incentives with the need for competition, promoting access and motivating important subsequent innovation, argues the prestigious New England Journal of Medicine, in its October 14 issue.

This past summer, committees in both the Senate and the House approved bills that would authorize the FDA to create an approval pathway for follow-on biologic, or biosimilar, products that would guarantee manufacturers 12 years of market exclusivity for a new biologic agent before any biosimilar product could be approved, even in the absence of a valid patent. Manufacturers could also obtain an additional 12-year exclusivity period by making minor changes to the structure of an approved product, such as those that could lead to changes in administration schedules (eg, from weekly to monthly). Supporters argue that these much longer periods of protection from competition are fair because the development costs for biologic products are higher than they are for other medications. However, the bills fail to recognize the unique characteristics of biologic drugs and upsets the delicate balance between the interests of consumers and those of innovators, the NEJM article argues.

The proposed legislation would also impose additional hurdles before therapeutically similar follow-on biologics could be declared interchangeable, it says.

In reality, it continues, the pharmaceutical industry's demand for a 12-year exclusivity period builds on one of the glaring failures of the Waxman-Hatch Act. The Act allows innovator companies to delay competition from generics for 30 months merely by asserting that their patents were infringed, even if this claim is not borne out.

Manufacturers of brand-name drugs have responded by seeking and obtaining many patents of questionable validity, engaging in frequent and costly patent litigation, and using litigated patents as vehicles for settlements in which they pay the manufacturers of potentially competitive generics to refrain from challenging their patents., it claims Congress is now considering additional legislation to prevent these abuses, which allow questionable patents to extend exclusivity improperly. For biologic products, innovators seek - and Congress seems willing to grant - an iron-clad 12-year exclusivity period that

Argument supported by GPhA

Commenting on the article Kathleen Jaeger, chief executive of the USA's Generic Pharmaceutical Association (GPhA), said that this 'is further evidence of the growing scientific and economic case rejecting the unprecedented and excessive market exclusivity periods currently contained in the House and Senate biogeneric bills.'

She continued: 'The authors go on to say that 'such a compromise would best balance the need for financial incentives with the need for competition, promoting access and motivating important subsequent innovation.' They point to the fact that for the last 25 years, the Hatch-Waxman Act has successfully achieved the goal of fostering innovation while also providing affordable medicines to consumers.'

'As the House Energy and Commerce Committee Chairman Waxman said last month, the 'war is not over' in the fight for affordable biogenerics. This article makes a strong and compelling case against the existing bills, which put brand pharmaceutical company profits ahead of patient needs. There is still time for Congress to get this right. President Obama has already put forth a reasonable compromise of seven years of market exclusivity to help move this debate forward. For the sake of patients searching for affordable life-saving medicines, it is incumbent upon Congress to listen to the President and put patients first,' Ms Jaeger concluded.