Top 5 Most-Read Policy Articles of 2025

In 2025, policy efforts intensely focused on reducing biosimilar barriers and promoting affordability worldwide, highlighted by a US bipartisan bill protecting skinny labeling to shield biosimilar manufacturers from costly patent litigation and a presidential executive order that emphasized biosimilars as the "clear answer" to sky-high US drug costs.

Here are the most-read biosimilar policy articles from 2025.

Here are the most-read biosimilar policy articles from 2025.

5. The Trump Administration’s Drug Price Actions and Why US Prices Are Already Sky-High

This article explores the complex factors contributing to the high cost of prescription drugs in the US, providing context for the Trump administration's second executive order aimed at lowering drug prices. The administration claimed the order would reduce current prescription drug prices by 59% by aiming to establish "most-favored nation" pricing, which they stated could reduce costs between 30% and 80%. Unlike many countries with price control policies, the US allows pharmaceutical companies to set and change their list prices freely. The resulting US prescription drug prices are nearly 3 times higher than in 33 Organisation for Economic Co-operation and Development countries, with brand-name innovator medications costing four times more. The US drug pricing crisis is rooted in high development costs, profit incentives, and the lack of comprehensive price control measures.

The article also noted that the administration signaled potential tariffs on pharmaceuticals, which could impact imported generics, biosimilars, and active pharmaceutical ingredients.

Read the full article here.

4. BioRationality: What’s Wrong With the Indian CDSCO Biosimilar Guidelines?

This piece submitted recommendations to the Indian Central Drugs Standard Control Organisation (CDSCO) regarding the revision of its 2016 "Guidelines on Similar Biologics." The report argues that rationality must prevail for biosimilars to flourish, advocating for extensive revisions to align the guidelines with current scientific understanding and the requirements of Stringent Regulatory Authorities (SRA). Author Sarfaraz K. Niazi, PhD, proposed removing requirements for preclinical studies, including pharmacodynamic and toxicological assessments in animals, because biological drugs do not necessarily show toxicity in animals and animal models often lack the necessary receptor binding.

The recommendations also called for the removal of requirements for multiple-dose comparative pharmacokinetic studies, noting that animal testing cannot reveal differences in protein products. Furthermore, the article argued that the requirement for "confirmatory phase 3 clinical efficacy studies" is often unnecessary and incorrect terminology for biosimilars, suggesting India adopt the UK’s position that such trials may not be needed if scientifically justified.

Read the full article here.

3. President Trump Signs Executive Order to Bring Down Drug Prices

President Donald Trump signed an executive order directing leaders of HHS, CMS, and the Office of Management and Budget to develop meaningful actions to address high drug costs for Americans. The order emphasized that safe, effective, and lower-cost biosimilars are the clear answer to skyrocketing prescription drug costs. It highlighted the potential for biosimilars to generate substantial savings—$56 billion already, with the potential for $181 billion more in the next 5 years.

The order included 13 directive actions, such as instructing the FDA commissioner to issue a report with recommendations to accelerate the approval of generics and biosimilars. It also mandated that HHS evaluate and propose regulations to prevent Medicare payment policies from incentivizing the use of costlier hospital-based drug administration over physician offices and directed the Secretary of Labor to propose regulations to increase employer health plan transparency into pharmacy benefit manager (PBM) compensation. The Biosimilars Forum applauded the administration for taking decisive action to support biosimilars and streamline their development based on science rather than bureaucracy.

Read the full article here.

2. Cost-Efficiency in Action: Denmark's Transition to Biosimilar Adalimumab

An observational cohort study confirmed the economic feasibility of biosimilar adoption following Denmark's nationwide mandatory switch from originator Humira (adalimumab) to biosimilar adalimumab. The study, utilizing the Danish DANBIO registry, found that the switch did not increase total health care costs over a 9-month period. Hospital costs, which accounted for approximately 90% of total health care costs, remained similar or even decreased after the transition for biosimilar switchers.

Specific analysis showed that health care costs decreased by 15% for patients with psoriatic arthritis and axial spondyloarthritis who switched to the GP2017 biosimilar. These findings were reassuring to the authors, as concerns had been raised about potential additional costs associated with increased health care utilization for patient education and monitoring during the transition.

Read the full article here.

1. Senators Introduce Bipartisan Legislation to Protect Skinny Labeling

In a major policy move to close out the previous year, 4 senators introduced a new bipartisan bill (S 5573), also known as the Skinny Labels, Big Savings Act, designed to accelerate the rollout of biosimilars and generic drugs. "Skinny labeling" is a strategy allowing follow-on drug manufacturers to seek approval only for specific indications of a branded drug, thereby avoiding "new-use" patents that often extend the originator's exclusivity.

The legislation would amend federal patent infringement law to protect biosimilar and generic drug manufacturers from costly patent litigation when they obtain skinny-label FDA approvals. The bill explicitly allows manufacturers to submit, market, and describe their skinny-labeled drug as a generic or therapeutic equivalent to the originator.

Proponents of the bill argued it is imperative for US patients, as it helps to "level the playing field" against the originator pharmaceutical companies' use of endless patent litigation. The estimated savings to Medicare from skinny-label biosimilars between 2015 and 2020 amounted to approximately $1.5 billion, and future savings are anticipated, especially with the expected market entry of adalimumab biosimilars using this strategy.

The bill was reintroduced in the House in December 2025 and is awaiting committee review.

Read the full article here.