Sanders Bill Would Allow Biosimilar “Pay-For-Data” System

Biosimilar manufacturers could buy access to existing clinical trial data to use in their applications and avoid conducting some clinical trials, if a bill filed by Sen. Bernard Sanders, I-Vt., is approved.

While the bill has been titled to encourage ethical research practices in the licensing of biologics by preventing biosimilar manufacturers from replicating clinical trials, it also would establish a “cost-sharing” model where innovator companies could offset some R&D costs.

Although it doesn't appear to have much chance of being adopted, the Sanders bill, S. 3921, would almost certainly affect how the new biosimilar and interchangeable products pathway is implemented.

Even though its legislative prospects are limited, the legislation may influence FDA's thinking as it develops data requirements for the biosimilars pathway (Also see "Biosimilars May Drift, But What Should FDA Do About It?" - Pink Sheet, 15 Nov, 2010.). Michael Behan, Sanders’ chief counsel and legislative director, presented the concept behind the bill at an open public session during the first afternoon of FDA's Nov. 2-3 biosimilars meeting.

Agency officials appeared to be wrestling with similar issues related to data access and requirements in the run-up to the meeting.

The Federal Register notice announcing the event suggested the agency may consider scenarios where clinical trials would not be needed to submit an application, and wanted input on whether to accept some data from studies comparing the biosimilar to a foreign reference product. Using that data might help avoid duplicative animal and human testing (Also see "Biosimilars On The Horizon: How Much Will FDA Look To The East?" - Pink Sheet, 1 Nov, 2010.).

Brand and generic companies are split on whether clinical trials should be required for all biosimilar applications. During the hearing, the agency tried to determine whether a policy allowing discretion is possible (Also see "FDA Searches For Clinical Trial Middle Ground At Biosimilar Hearing" - Pink Sheet, 8 Nov, 2010.).

Fees Would Be Public

Sander's bill would set up a system where a biosimilar applicant would pay a fee to use existing data and avoid conducting a study that already had been done. Only data required for application approval would be shared.

The applicant and data holder would be encouraged to negotiate a fair fee to use the data, under the system described in the bill.

The fee would be based on five criteria:

• out-of-pocket costs of the clinical trials;

• likelihood that other trials result in applications approved by FDA;

• any federal grants, tax credits or other subsidies that lowered the net cost of the trials;

• the expected net global market share for the applicant’s product; and,

• the length of time the data holders have benefited from market exclusivity and the revenue earned from the data holders’ products.

If the two sides could not reach an agreement, the FDA Commissioner could send the matter to binding arbitration or independently determine a reasonable fee, according to the bill.

The fee amount, clinical trial costs and other information also would be made public. If the data holder does not maintain an exclusive right to rely on it, the disclosure requirements would not apply.

The bill was sent to the Senate Committee on Health, Education, Labor and Pensions on Sept. 29, but has not received any further action.

By Derrick Gingery