New Bill Aims to Remove Barriers to Interchangeable Biosimilars

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A new bill (HR 8877) introduced to the House of Representatives is seeking to remove barriers that prevent the substitution of reference products with interchangeable biosimilars to support utilization of and access to lower-cost therapies.

The Biologics Competition Act of 2022 (HR 8877), a bill aiming to make interchangeable biosimilars more accessible for patients in the United States, was introduced in the House of Representatives.

The bill is sponsored by Representative Mariannette Miller-Meeks, R-Iowa, and it was referred to the House Committee on Energy and Commerce. The legislation has received bipartisan support, including from Representatives Greg Murphy, R-North Carolina; Nanette Barragán, D-California; and Ann (Annie) Kuster, D-New Hampshire.

If passed and signed into law, the bill would task HHS with conducting a study that could assess current challenges to substituting reference biologics with biosimilars and interchangeable biologics. The results would then be shared with Congress. The hope is that the results can help Congressional leaders identify potential policy solutions that can increase public trust in interchangeable products and biosimilars and remove barriers to their utilization.

HHS would also be directed to update the FDA’s Purple Book, a list of licensed biological products and patent disclosures, and adjust it to better align communications related to the interchangeability of reference products and biosimilars.

Changes to the Purple Books should “harmonize the approach for communicating the substitutability of interchangeable biological products with the approach for communicating therapeutics equivalence ratings assigned to drugs, with the goals of minimizing impediments to substitution…and maintaining the distinct pathways by which biological products are licensed under…the Public Health Service Act and drugs are approved under…the Federal Food, Drug, and Cosmetic Act,” according to the bill’s text.

The bill comes after the first provision of the Inflation Reduction Act that impacts biosimilars, a 5-year temporary increase in the add-on payment for qualifying biosimilars to encourage their utilization, went into effect. Additionally, the European Medicines Agency declared all biosimilars interchangeable with their reference products in September.

Recently, Cimerli, the first interchangeable ophthalmology biosimilar, entered the US market, making it the second interchangeable biosimilar to be made available to American patients, following the relaunch of Semglee (insulin glargine biosimilar) with an interchangeable label.

In response to the bill’s introduction in Congress, Vizient, a member-driven health care performance improvement company, issued a response showing its support of HR 8877. Vizient thanked the Congressional leaders who signed onto the legislation and vowed to work with them, other government partners, including the FDA, and Vizient members to improve adoption of biosimilars and interchangeable products.

“Biosimilars have proven to be safe and effective while providing significant cost savings for providers and patients. In fact, biosimilars contributed over $12.6 billion in savings in the U.S. from 2015 through 2022. This effort to improve the substitution process for interchangeable biological products will make affordable and life-saving medications more accessible to those in need while reducing costs,” said Steven Lucio, senior principal of pharmacy solutions at Vizient, in a statement.

Vizient also sent a letter to the bill sponsors alerting them to Vizient’s support and stressing the importance of progressing HR 8877: “Despite the growing number of biosimilar products entering the market and seeking to be designated as interchangeable, confusion persists among clinicians and payers as to the substitution of interchangeable biosimilars with originator biologics. Your important bipartisan legislation offers concrete solutions to minimize obstacles to the substitution of interchangeable biologics.”

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