Biosimilars Get a Boost in Senate's Sweeping Healthcare Package

Yesterday, the Senate Committee on Health, Education, Labor, and Pensions (HELP) released bipartisan draft legislation aimed at lowering the cost of healthcare in the United States.

The package was introduced by chairman Lamar Alexander, R-Tennessee, and ranking member Patty Murray, D-Washington. Among the 5 sections of the package, the Lower Health Care Costs Act, is a swath of proposals aimed at reducing the prices of prescription drugs, prominently featuring biosimilars’ role in doing so.

This portion of the legislation would require updates to the FDA’s Purple Book, which provides stakeholders with information on biologics. The legislation would codify the Purple Book as a single, searchable list of information that would include, among other information, materials related to patents on biologics.

This section of the legislation also proposes to make updates to the Orange Book, which addresses small-molecule drugs. The FDA would be required to remove patent information if a patent is found to be invalid.

The House of Representatives recently passed similar legislation that would requires these same changes to the Purple and Orange Books.

The Senate’s package also addresses the abuse of citizen petitions, saying that the FDA can deny a petition that is submitted with the aim of delaying approval of a competitive drug and allowing HHS to refer such petitions to the Federal Trade Commission.

Additionally, the legislation clarifies that transition products cannot receive new marketing exclusivities and prevents first-to-file generic applicants from blocking subsequent entrants beyond a 180-day exclusivity period. It codifies the March 2020 transition of these products—including insulin—into law, and states that marketing applications that are submitted 6 months before the transition will not need to be resubmitted to the FDA.

The proposed legislation also stipulates that the FDA would be required to establish a website for stakeholder education on biologics, including biosimilars and interchangeable products, and allows for the development and improvement of continuing medical education for providers on these topics.

Notably, the bill excludes all biologics from requirements to follow the United States Pharmacopeia’s standards.

In an email to The Center for Biosimilars^®, a representative from the Biosimilars Forum voiced the organization’s support for the bill, saying that “The Biosimilars Forum commends the Senate HELP Committee for including language that would direct the FDA to close the education gap and expel misinformation about biosimilars for both patients and providers. Misinformation and a lack of understanding about lower-cost biosimilars is threatening patients’ access to these life-saving therapies and costing the US billions in untapped savings throughout the health care system.”

The additional 4 sections of the bill include the following objectives:

Ending surprise medical bills

This portion of the legislation proposes to protect patients from out-of-network deductibles when seeking emergency care, and to ensure that patients are held harmless from surprise medical bills. Patients would be required to pay only their in-network cost-sharing amount for out-of-network emergency care.

Improving transparency in healthcare

This component of the package would, among other provisions, create a nonprofit entity to improve transparency of healthcare costs, require health plans to have up-to-date directories of their in-network providers, require healthcare facilities to engage in timely billing, prohibit pharmacy benefit managers (PBMs) from engaging in spread pricing, and require PBMs to pass on all of their rebates to plan sponsors.

Improving public health

This portion of the package includes such provisions as raising awareness of vaccines and combatting vaccine-related misinformation, requiring HHS to disseminate a guide on obesity prevention, and establishing a grant program for improving maternal healthcare quality.

Improving the exchange of health information

Included in this segment of the legislation are provisions that would require the Government Accountability Office to investigate gaps in privacy and security protections for patients’ health information and incentivize strong cybersecurity practices.

In a statement, Alexander said that he expects a vote on the act in July 2019.