In its report, the Congressional Budget Office (CBO) notes that it “expects that the bill’s provisions would allow generic drugs (including biosimilar versions of biologics) to enter the market earlier, on average, than they would under current law.” Additionally, CBO said that enacting the legislation would reduce federal spending on prescription drugs.
Last week, the nonpartisan Congressional Budget Office (CBO) announced its cost estimate of implementing S. 974, the Creating and Restoring Equal Access to Equivalent Samples Act of 2018, otherwise known as the CREATES Act.
If adopted, the CREATES Act would create a legal pathway to allow generic and biosimilar drug developers to bring civil lawsuits against manufacturers of brand-name drugs if “sufficient quantities of reference samples of a branded product are not made available for premarket testing.”
Additionally, the CREATES Act also seeks to remove a statutory requirement that manufacturers of generic or biosimilar versions of certain drugs that carry a significant risk of serious adverse effects would use the same risk management system as the reference product. Instead, it would allow the FDA to enable those manufacturers to use comparable safety systems on a case-by-case basis. In recent months, FDA Commissioner Scott Gottlieb, MD, has spoken out about this issue, and has made it a priority of the agency to tackle Risk Evaluation and Mitigation Strategy (REMS) abuse that stalls competition in the market.
Click here to read more about the CREATES Act.
In its report, CBO notes that it “expects that the bill’s provisions would allow generic drugs (including biosimilar versions of biologics) to enter the market earlier, on average, than they would under current law.” Additionally, CBO said that enacting the legislation would reduce federal spending on prescription drugs.
In total, CBO and the staff of the Joint Committee on Taxation estimated that implementing the bill would reduce spending by $3.3 billion over the 2019 to 2028 period; increase revenues by $600 million over the same period; reduce unified budget deficits by $3.9 billion over the same period; and reduce spending subject to appropriation, on net, by $87 million over the 2019 to 2023 period.
Despite broad bipartisan support, the CREATES Act has faced opposition from pharmaceutical companies and industry trade groups, such as the Pharmaceutical Research and Manufacturers of America (PhRMA), which spent an estimated $10 million on lobbying efforts—including efforts to stall progress of the CREATES Act–in the first quarter of 2018.
The bill is currently up for vote in the Senate, where it has been pending since it was reported on June 14, 2018.
Budget Impact Analysis of Biosimilar Natalizumab in the US
Projected savings from biosimilar natalizumab were $452,611 over 3 years, driven by decreased drug acquisition costs and a utilization shift from reference to biosimilar natalizumab.
Biosimilars in America: Overcoming Barriers and Maximizing Impact
July 21st 2024Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.
Biosimilars Policy Roundup for April 2024—Podcast Edition
May 5th 2024On this episode of Not So Different, The Center for Biosimilars® glances back at all the major biosimilar policy updates from April, including 2 FDA approvals, 1 European approval, and several insights into possible policy changes from the Festival of Biologics USA conference.
Hesitancy in MENA Nations to Adopt WHO Biosimilar Guidelines Hinders Market Development
July 17th 2024The World Health Organization’s (WHO) new guidelines for biosimilar approvals aim to save time and money for manufacturers in the Middle East and North Africa (MENA), but hesitancy among nations to adopt the guidelines is stifling market development of biosimilars.
BioRationality: Time to Get Rid of PBMs if Biosimilars Are to Succeed
July 15th 2024Sarfaraz K. Niazi, PhD, discusses the challenges with pharmacy benefit managers (PBMs) that plague the biosimilar industry and new legislation that attempts to reform their practices and encourage biosimilar adoption.