Drug Makers And Payers To Blame For Biosimilar Barriers In U.S. Market

Biosimilars are gradually gaining traction in the U.S. outpatient drug market, offering a more cost-effective alternative to expensive branded biologics. However, the path to market access for biosimilars, particularly those referencing popular drugs like Stelara, is fraught with challenges. Payers and pharmacy benefit managers play a crucial role in determining which biosimilars are favored, often opting for more expensive options over the cheapest versions.

Biologics are complex drugs derived from living organisms that are used to treat various conditions such as autoimmune disorders, cancer, and diabetes. Biosimilars are highly similar versions of already approved biologics, offering a more affordable option once the patent for the reference product expires. While biosimilars have the potential to significantly reduce healthcare costs, barriers in the U.S. market, including patent litigation and payer dynamics, hinder their uptake.

The U.S. biosimilar market has been plagued by patent thickets, where branded biopharmaceutical manufacturers use multiple patents to prolong their market exclusivity and prevent biosimilar competition. This has led to lengthy legal battles, as seen in the case of Humira, a popular autoimmune drug. Despite the patent for Humira expiring in 2023, biosimilars faced delays in entering the market due to settlement agreements between the sponsor and biosimilar manufacturers. Consequently, Humira still maintained a dominant market share in early 2025, highlighting the challenges faced by biosimilars in gaining traction in the U.S.

In contrast, European markets have seen greater success with biosimilars, with adalimumab biosimilars quickly capturing market share after the patent expiration of Humira. The difference in market dynamics between the U.S. and Europe underscores the need for a more competitive landscape and greater access to biosimilar alternatives.

Apart from patent issues, pharmacy benefit managers have also been criticized for favoring more expensive products over cheaper biosimilar options. In some cases, PBMs have excluded lower-cost biosimilars from coverage in favor of private-label versions, leading to increased prescriptions for more expensive alternatives. This trend is now being observed in the case of Stelara and referenced biosimilars, highlighting the need for greater transparency and competition in the pharmaceutical supply chain.

Overall, the challenges facing biosimilars in the U.S. market underscore the need for regulatory reforms and greater competition to ensure that patients have access to affordable and effective treatment options. As the demand for biologic drugs continues to grow, addressing these barriers is essential to promoting innovation and improving patient outcomes in the healthcare system. In the realm of autoimmune conditions, medications like Stelara have long been a staple in treatment plans. However, in 2025, the landscape shifted with the introduction of four new biosimilars that entered the market following legal settlements. These biosimilars offer list price discounts ranging from 5% to 95% lower than the original Stelara.

One interesting development is the emergence of private-label versions of these biosimilars. OptumRx, a subsidiary of UnitedHealth Group, launched a private label Stelara biosimilar named Wezlana through its Nuvaila business. This offering includes both a high-list priced version, which is 81% off of Stelara’s wholesale acquisition cost, and a low-list priced version that is just 5% lower. It’s worth noting that even the low-list price version is higher than the unbranded biosimilar offered by the independent PBM MedImpact, which is available at a 95% discount from Stelara.

The two-price approach adopted by OptumRx sheds light on the complex pricing strategies in the pharmaceutical industry and how they can impact patients. This strategy mirrors what we’ve seen with biosimilars of other medications like Humira. For instance, Amjevita, the first biosimilar of Humira, was launched with two different list prices, a 5% and 55% discount respectively. Similarly, Yusimry offers an 85% discount but is excluded from OptumRx’s formulary.

When it comes to choosing between high-list price biosimilars or private-label versions, employers and health plans face a dilemma. They must decide whether to prioritize low net cost or opt for a high wholesale acquisition cost with high rebates. This decision can significantly impact patients, especially those with co-insurance who end up paying more out-of-pocket.

The involvement of PBMs in this pricing structure introduces additional complexities and potential conflicts of interest. PBMs may have a financial stake in biosimilar sales through affiliated companies, leading to concerns about transparency and fairness in the selection and promotion of certain products over others. This lack of transparency can result in biosimilar manufacturers being excluded from coverage or facing restricted access.

In an ideal competitive market, information is readily available, and firms can freely enter or exit the market. However, the pharmaceutical industry, particularly in the realm of biosimilars, often lacks this level of transparency and competition. Both drug makers and payers share responsibility for barriers to entry, information imbalances, and opaque pricing practices.

Overall, the introduction of biosimilars offers promise for cost savings and increased access to essential medications. However, it also underscores the need for greater transparency, fair competition, and patient-centered decision-making in the pharmaceutical industry.