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.
Targeted Reimbursement Encourages Oncology Biosimilar Use
May 7th 2025Incentivizing physicians with modest financial bonuses may seem like a small step, but in Japan’s outpatient oncology setting, it helped push trastuzumab biosimilars toward broader adoption, demonstrating how even limited reimbursement reforms can reshape prescribing behavior under the right conditions.
Escaping the Void: All Things Biosimilars With Craig & G
May 4th 2025To close out the Festival of Biologics, Craig Burton and Giuseppe Randazzo from the Association for Accessible Medicines and the Biosimilars Council tackle the current biosimilar landscape and how the industry can emerge from the "biosimilar void."
Samsung Bioepis Report Signals Turning Point for US Biosimilars
May 1st 2025A wave of biosimilar approvals, aggressive pricing strategies, and a regulatory sea change are setting the stage for unprecedented momentum in the US biologics market, with 2025 already proving to be a landmark year in reshaping cost, access, and innovation across therapeutic areas.
How AI Can Help Address Cost-Related Nonadherence to Biologic, Biosimilar Treatment
March 9th 2025Despite saving billions, biosimilars still account for only a small share of the biologics market—what's standing in the way of broader adoption and how can artificial intelligence (AI) help change that?
Biosimilar Market Development Requires Strategic Flexibility and Global Partnerships
April 29th 2025Thriving in the evolving biosimilar market demands bold collaboration, early global partnerships, and a fresh approach to development strategies to overcome uncertainty and drive future success.
Eye on Pharma: Sandoz Files Antitrust Suit; Yuflyma Interchangeability; Costco’s Ustekinumab Pick
April 22nd 2025Sandoz's antitrust suit against Amgen, the FDA’s interchangeability designation for Celltrion’s adalimumab biosimilar, and the inclusion of an ustekinumab biosimilar in Costco’s prescription program highlight growing momentum to expand biosimilar access and affordability for patients with chronic inflammatory diseases.