BIO and GPhA support biosimilar and generic user fees

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BIO and GPhA support biosimilar and generic user fees

Biosimilares/General | Posted 06/04/2012 0 Post your comment

Both the Biotechnology Industry Organization (BIO) and the Generic Pharmaceutical Association (GPhA) have expressed their support of user fees for biosimilars and generics.

Ms Sara Radcliffe, Executive Vice President for Health at BIO, testified on 29 March 2012 on the Biosimilar User Fee Act (BsUFA) at the Senate Health, Education, Labor and Pensions Committee Hearing on the 2012 FDA User Fee Agreements.

In her testimony, Ms Radcliffe expressed support for the establishment of a biosimilars user fee programme as part of the FDA’s implementation of a well-constructed, science-based pathway for the approval of biosimilar products that protects patient safety and preserves incentives for innovative new therapies.

‘A transparent, predictable, and balanced regulatory framework for the review and approval of biosimilars, accompanied by reasonable performance goals and a dedicated, independent funding stream, will ensure that FDA can facilitate the development and evaluation of biosimilars products,’ Ms Radcliffe testified.

‘BsUFA will provide FDA with the resources and capacity to facilitate the development and evaluation of biosimilars products, while also continuing to prioritise the review of innovative drugs and biologicals under Prescription Drug User Fee Act (PDUFA) so that safe and effective new therapies–many for currently untreatable and serious diseases–can be made readily available to patients,’ she stated.

BIO believes that a principal goal of the new biosimilar user fee programme must be to ensure that the workload associated with biosimilar applications does not impede the FDA’s ability to efficiently review innovative new drugs and biologicals, and that new treatments continue to have the highest review priority.

‘The generics industry has stepped up to do our part to help ensure US drug safety, establish a more level playing field among all participants in the US pharmaceutical supply chain and significantly reduce the time needed to commercialize a generic drug,’ Mr David Gaugh, GPhA Vice President for Regulatory Sciences, said in his testimony before the Senate Committee; adding that ‘the [user fee] programmes will help assure that American consumers continue to receive the significant cost savings from generics that, over the past dozen years, have provided more than US$1 trillion in savings to the nation’s healthcare system.’

The Generic Drug User Fee Act calls for the generic drug industry to pay US$299 million annually in user fees for the next five years, starting on 1 October 2012. This funding is supplemental to what US Congress appropriates to FDA each year and will enable the FDA’s Office of Generic Drugs to hire the scientific resources needed to provide timely approval of generic medicines. The new fees also will provide increased funding for generics manufacturer facility inspections, which are required before new generics can be approved.

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Source: BIO, GPhA