More than 100 House Democrats this week wrote to US Trade Representative Robert E. Lighthizer to ask him to drop language from the United States-Mexico-Canada Agreement (USMCA) trade agreement that would give 10 years of marketing exclusivity for biologic drugs.
More than 100 House Democrats this week wrote to US Trade Representative Robert E. Lighthizer to ask him to drop language from the United States-Mexico-Canada Agreement (USMCA) trade agreement that would give 10 years of marketing exclusivity for biologic drugs.
The biosimilars industry has been working since earlier this year to convince legislators to join them in opposing a pharmaceutical intellectual property provision in the renegotiated trade agreement with Canada and Mexico, which they say will create higher drug prices in the United States.
In the letter, the legislators say that the proposed language would prevent Congress from having the ability to “adjust the biologics exclusivity period, instead locking the US into policies that keep cancer and other drug prices high while exporting this model to Mexico, which has no additional exclusivity period for biologics, and to Canada, which has an 8-year period.”
In a statement, the Association for Accessible Medicines said it hopes that an agreement is reached in time for a vote in the fall. Innovator biotechnology firms and pharmaceutical industry groups, such as the Biotechnology Innovation Organization, known as BIO, and the Pharmaceutical Research and Manufacturers of America, known as PhRMA, approve the intellectual property language currently in the agreement.
The president had secured agreements with Canada and Mexico last year on the USMCA, an updated version of the North American Free Trade Agreement, but since then, Democrats have taken control the House of Representatives.
In a joint statement, Representatives Jan Schakowsky, D-Illinois and Rosa DeLauro, D-Connecticut, both members of the House Democrats working group tasked with trying to work with Lighthizer, praised the trade representative’s efforts, but added, “unless and until President Trump instructs Ambassador Lighthizer to remove the biologics exclusivity language from the text of the United States-Mexico-Canada trade agreement, as well as other parts of the text that would hinder Congress’ ability to lower prescription drug prices for American families, his talk about wanting to lower drug prices is just that: talk.”
Last month, Schakowsky and DeLauro introduced HR 3379, which would shorten the exclusivity period for brand name biological products from 12 to 5 years.
Separately, in Canada, there are fears that the USMCA language could raise drug prices there, as well. A report in a benefits newsletter cited a Parliamentary Budget Office (PBO) report that says a new agreement, as it currently stands, would cost Canadians millions in higher drug costs. Estimating average annual costs from 2015 to 2023, the PBO said protection for 16 biologics worth CAN $422.4 million of the CAN $1.26 billion in prescription sales in 2015 were set to expire in the shorter 8-year time frame, or an average of CAN $52.8 million per year. Consumers and drug plans would pay an additional $23.8 million per year in that time period because of the longer protections.
Julie Reed: Why 2024 Is Important for Biosimilars
April 17th 2024Julie Reed, executive director of the Biosimilars Forum, showcases how the biosimilar industry is expected to develop throughout 2024, including major policy changes and hope for continued improvement in market share for adalimumab biosimilars.
A New Chapter: How 2023 Will Shape the US Biosimilar Space for 2024 and Beyond
December 31st 2023On this episode of Not So Different, Cencora's Brian Biehn and Corey Ford take a look back at major policy and regulatory advancements in 2023 and how these changes will alter the space going forward.
BioRationality: Removing the Misconceptions Surrounding Interchangeability
April 15th 2024Sarfaraz K. Niazi, PhD, outlines the current state of interchangeable biosimilars in the US and policy changes needed to clear up misconceptions surrounding the meaning behind interchangeability designations.
What AmerisourceBergen's Report Reveals About Payers, Biosimilar Pricing Trends
May 28th 2023On this episode of Not So Different, Tasmina Hydery and Brian Biehn from AmerisourceBergen discussed results from a recent survey, that were also presented at Asembia 2023, diving into the payer perspective on biosimilars and current pricing trends across the US biosimilar industry.
Rising Biosimilar Adoption for an Italian Payer Will Benefit National Health Care System, Patients
April 9th 2024Data from 2021 and 2022 indicates increasing biosimilar use in an Italian health care company, with potential for full adoption in the future, benefiting both the National Health System and citizens through efficient and sustainable health care policies.
Review Highlights Most Popular European Policies to Boost Biosimilar Uptake
April 3rd 2024Although tender systems are a common strategy to encourage biosimilar utilization across Europe, policies like automatic substitution are rarely utilized, according to a systematic review of European policies and biosimilar uptake.