Under Section 11403 of The Inflation Reduction Act, effective starting on Monday, October 3, 2022, and for the next five years, Medicare Part B will pay healthcare providers an 8% add-on fee for qualifying biosimilars, replacing the previous 6% markup. The add-on fee applies to qualifying biosimilars whose average sales…
On Tuesday, January 25, Senate Health, Education, Labor, and Pensions (HELP) Committee Chair, Senator Patty Murray (D-WA), and Ranking Member, Senator Richard Burr (R-NC) released a discussion draft of the Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act (PREVENT Pandemics Act). According to the Senate…
On July 13, 2021, the Senate Judiciary Committee’s antitrust panel met to discuss biologic and biosimilar competition and its impact on drug prices. A group of senators, led by Senator Amy Klobuchar, are sponsors of a Senate bill which aims to prohibit biological product manufacturers from compensating biosimilar and interchangeable…
On July 1, 2021, twenty-eight patient advocacy groups submitted a letter demonstrating their support for the BIOSIM Act (H.R. 2815). The legislation was introduced on April 22, 2021 with the purpose of increasing Medicare payments for biosimilars for a five-year period. The letter praises the BIOSIM Act as “critical to…
On April 26, Representatives Paul D. Tonko (D-NY) and Bob Gibbs (R-OH) introduced the Star Rating for Biosimilars Act. The proposed legislation would direct the U.S. Department of Health & Human Services (HHS) to evaluate Medicare plans based on whether or not cost-saving biosimilars are available to enrollees and to evaluate…
The Senate passed a bill (S. 164) earlier this month (on March 3, 2021) “[t]o educate health care providers and the public on biosimilar biological products, and for other purposes.” The proposed “Advancing Education on Biosimilars Act of 2021” would add a section to the Public Health Service Act on…
Last Wednesday, State Senator Carla Nelson and State Representative Jennifer Schulz of Minnesota announced the introduction of a bill aimed at reducing the price of certain medications by expanding access to biosimilars. The bill requires that pharmacy benefit managers and health carriers must not require or demonstrate a preference to…
On January 5, 2021, the President signed H.R. 1503 (the Orange Book Transparency Act of 2020). The Orange Book Transparency Act of 2020 clarifies information related to patent listing and the types of patents that should be listed in the Orange Book. The Act also requires that NDA holders notify…
As we close out another calendar year, we look back at the top legal developments of 2020 that could influence the market for biologics and biosimilars. While there were a number of case-specific decisions this past year that, undeniably, impacted the availability of biosimilars in the market, the five legal…
On December 27, the President signed the Consolidated Appropriations Act, which includes two provisions relevant to biosimilars: First, Section 322 of Division BB permits but does not require aBLAs to include information to show that the biosimilar’s conditions of use are the same as conditions of use approved for the…