Top 5 Most-Read Biosimilar News of 2025

The US biosimilar market continues to evolve rapidly, characterized by significant milestones in patient access and persistent challenges related to market acceptance and policy barriers. The following roundup details the key news items from 2025 that reflect the current state and future trajectory of biosimilar adoption, covering everything from landmark approvals and market competition struggles to major regulatory and political efforts aimed at enhancing affordability and sustainability.

Here are the most-read biosimilar news articles of 2025.

Explore the latest developments in the US biosimilar market, highlighting key approvals, challenges, and future trends shaping patient access in 2025.

5. From Amjevita to Zarxio: A Decade of US Biosimilar Approvals

Since the FDA granted its landmark decision to approve the first biosimilar, Sandoz’ filgrastim-sndz (Zarxio), on March 6, 2015, the US biosimilars market has grown substantially, accumulating 67 total approvals across 18 originator products over 10 years. This expansion has delivered significant cost savings, with generics and biosimilars collectively generating $12.4 billion in savings during 2023, bringing the total savings since 2015 to $36 billion.

A major focus of this decade was the adalimumab market, which saw the entry of 10 biosimilars beginning with Amgen’s Amjevita (adalimumab-auub) in January 2023. Despite this growth, biosimilars only account for about 23% of the overall biologics market, with uptake varying drastically across therapeutic areas; for instance, it is higher in oncology and lower in chronic conditions like rheumatology and gastroenterology. Major challenges hindering biosimilar adoption include regulatory barriers requiring extensive studies for approval and interchangeability, low market acceptance driven by payer controls and provider preferences, and high development costs, which can range from $100 million to $250 million.

Reference manufacturers have also utilized the patent legal system to stall competition, notably resulting in delayed launches for the adalimumab biosimilars. However, there is optimism for policy changes, including draft FDA guidance that might remove switching study requirements for interchangeability status, aligning the US more closely with European regulatory agencies.

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4. Skyrizi Overtakes Humira: “Product Hopping” Leaves Biosimilar Market in Limbo

The launch of 10 adalimumab biosimilars, which began with Amgen's Amjevita in January 2023, created hope for robust competition; however, the sustainability of this market is now under threat. AbbVie’s Skyrizi (risankizumab-rzaa) surpassed the originator product, Humira (adalimumab), to become the company's top sales driver for the first time, according to AbbVie’s Q3 2024 financial report.

The shift is a consequence of "product hopping," a strategy used by drug companies to encourage demand to move from an innovator drug facing biosimilar competition to a newer, patented version from the same manufacturer. In Q3 2024, Skyrizi sales increased by 50.8% globally, while Humira’s worldwide revenues fell by 37.2%.

Although the combined market share for the 10 adalimumab biosimilars reached 22% by October 2024, experts noted that biosimilars are gaining share in a diminishing market, as the overall volume of adalimumab is shrinking due to the adoption of replacement products like Skyrizi. The practice of product hopping can hinder fair competition and allow originator companies to maintain near-monopolies. While the Affordable Prescriptions for Patients Act of 2023 was introduced in Congress to prohibit such practices, the bill currently remains stalled in the House.

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

President Donald Trump signed an executive order to address escalating drug costs by promoting faster biosimilar development, increasing transparency, and imposing tougher regulations on pharmacy benefit managers (PBMs). The executive order highlighted the substantial cost-saving potential of biosimilars, which can cost up to 80% less than reference biologics. The order projected the potential to save up to $181 billion over the next 5 years, building on the $56 billion in savings biosimilars had already generated.

Among the 13 directive actions outlined, the order specifically mandates the FDA commissioner to submit a report detailing recommendations to accelerate the approval of generics and biosimilars.

The order directs HHS to propose regulations aimed at increasing employer health plan transparency regarding PBM compensation. The order also sought to improve upon the Inflation Reduction Act by requiring HHS to issue guidance to enhance transparency in Medicare drug price negotiations and prioritize high-cost drugs. Accelerating biosimilar approval and development is a bipartisan objective, reflected by numerous bills introduced in Congress.

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2. The Biosimilar Void: 90% of Biologics Coming Off Patent Will Lack Biosimilars

A report from the IQVIA Institute for Human Data Science identified a significant “biosimilar void,” revealing that 90% of the 118 biologics scheduled to lose exclusivity over the next decade currently lack biosimilars in development. This represents a vast missed opportunity, as the affected biologics account for $234 billion overall in sales that could be exposed to competition through 2034.

The next decade will see an average of 12 biologics lose exclusivity annually, which is more than double the rate of the preceding decade. Biosimilar development remains concentrated on high-sales products, particularly in immunology and oncology, leaving therapeutic areas such as neurology, diabetes, and hematology with limited competition. The primary reason for this void, particularly among lower-sales biologics, is the high development cost, which ranges from $100 million to $250 million, coupled with a low projected return on investment. This is exacerbated in the rare disease space, where 61% of patent expiries through 2034 are orphan indications.

Other deterrents include regulatory burdens, low market acceptance, and reimbursement challenges as PBMs and payers favor originators due to rebate incentives. The report emphasized that addressing these development and market challenges through regulatory streamlining, collaboration, and improving market conditions is crucial for realizing the full affordability benefits of biosimilars.

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1. Welcome Wezlana: The First Stelara Biosimilar to Launch in the US

January 2025 marked a major milestone with the US launch of Amgen’s Wezlana (ustekinumab-auub), the first biosimilar referencing Stelara (ustekinumab), introducing a new category of lower-cost biologics for patients with conditions such as Crohn disease and plaque psoriasis. Wezlana’s approval was supported by phase 3 trial data confirming its comparable safety and efficacy profiles relative to the reference product.

Wezlana received an interchangeability designation, allowing it to be substituted for Stelara at the pharmacy level without requiring prior approval from a health care provider, which is intended to increase patient access and convenience. Amgen had previously settled with Johnson & Johnson, the parent company of the manufacturer of Stelara (Janssen), resulting in a delayed launch date of “no later than January 1, 2025.” Wezlana was the first of 7 ustekinumab biosimilars expected to launch in 2025.

However, following the experience in the adalimumab market, experts expressed concern regarding potential “product hopping” in the ustekinumab space, especially since Janssen, Stelara's manufacturer, also markets Tremfya (gusekumab), which could be used to shift patients away from the new biosimilar competition.

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