According to an unofficial estimate by the Congressional Budget Office, the Biosimilars Competition Act of 2018 will save about $100 million from 2019 to 2028.
In July, Congressman John Sarbanes, D-Maryland, introduced the Biosimilars Competition Act of 2018 in the United States Congress House of Representatives. Key components of the bipartisan bill authored by Congressman Sarbanes were passed this week by the House.
The bill will require both biologic and biosimilar developers to report agreements to the Federal Trade Commission (FTC) if they keep lower-cost drugs off the market. Such agreements, often referred to as “pay-for-delay” deals, have been coming under more scrutiny this year, as agreements between brand name drug makers and biosimilar developers have garnered more attention.
Click here to read more about pay-for-delay deals.
“We must take every step possible to prevent Big Pharma from continuing to raise drug prices on hardworking American families,” said Sarbanes. “This bill will help lower prescription drug costs by bringing more affordable biosimilar drugs to the market.”
According to a 2013 report from the FTC, pay-for-delay deals have increased yearly. In 2005, 3 such deals were made between brand name and generic manufacturers. In 2012, 40 pay-for-delay deals were made. The report found that these deals cost consumers an estimated $3.5 billion each year.
Drug maker AbbVie has made the news this year by entering into no fewer than 3 agreements with biosimilar developers which have resulted in keeping their respective adalimumab biosimilar products off the market in the United States until 2023. Notably, Senators Chuck Grassley R-Iowa, and Amy Klobuchar, D-Minnesota, urged the FTC to investigate AbbVie’s settlements with these developers to assess whether they were pay-for-delay agreements.
According to an unofficial estimate by the Congressional Budget Office (CBO), the Biosimilars Competition Act of 2018 will save about $100 million from 2019 to 2028. “The Biosimilars Competition Act will not only help bring lower-cost biosimilar drugs to market more quickly, but also help pay for two other fixes that will end pharmacy gag clauses and increase Americans’ access to affordable generic drugs,” said the CBO.
One of these fixes, titled the “Patient Right to Know Drug Prices Act,” was passed in the Senate by a vote of 98 to 2 earlier this month. The bill, introduced in March by Senators Susan Collins, R-Maine; Claire McCaskill, D-Missouri; and Debbie Stabenow, D-Michigan, eliminates pharmacy “gag clauses,” which are contractual agreements between pharmacy benefit managers and pharmacies that prevent pharmacists from telling consumers when they could spend less on their medication by paying out-of-pocket.
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.
Exploring the Biosimilar Horizon: Julie Reed's Predictions for 2024
February 18th 2024On this episode of Not So Different, Julie Reed, executive director of the Biosimilars Forum, returns to discuss her predictions for the biosimilar industry for 2024 and beyond as well as the impact that the Forum's 4 new members will have on the organization's mission.
Alvotech’s Stelara Biosimilar, Selarsdi, Receives FDA Approval
April 16th 2024Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.
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.
Global Biosimilar Market Projected to Reach $1.3 Trillion by 2032
April 11th 2024The global biosimilar market is projected to surge from $25.1 billion in 2022 to approximately $1.3 trillion by 2032, with a compound annual growth rate of 17.6%, driven mainly by the increasing prevalence of cancer and the cost-effectiveness of biosimilars, as outlined in a report by Towards Healthcare.