A recent study published in JAMA found that as the acquisition prices of bevacizumab, rituximab, and trastuzumab fell from 2020 to 2024, hospitals’ profits on each biosimilar purchase increased, and the uptake of these oncology biosimilars rose quickly. This could be an important lesson for the upcoming Keytruda and Opdivo biosimilar launches.

Researchers from the University of California, Berkeley and Brown University found that for the oncology therapies bevacizumab, rituximab, and trastuzumab, hospitals profited handsomely from the use of biosimilars over their reference products. Their study was published March 11 in JAMA.

The overall biosimilar uptake of these three products has been a model for the rest of the biosimilar industry in that uptake was rapid (achieving >60% utilization by year 3) and > 60% average sales price (ASP) declines occurred over four years. These biosimilars first entered the market in 2019. According to the Samsung Bioepis Biosimilar Trend Report, ASPs have now dropped below $1,000 for several biosimilars in all three drug categories, with the most extreme drop for Trazimera, a biosimilar of trastuzumab, at an ASP of $112 per 420 mg dose. Biosimilar uptake is over 85% for the bevacizumab and trastuzumab categories and at 78% for rituximab.

Biosimilar Acquisition Prices Dropped, Hospital Profit Rose

The researchers collected data from Blue Cross Blue Shield health insurance plans that contained drug acquisition costs, drug reimbursements by the insurers, hospital eligibility for 340B discounts, and other information from 2020 to 2024. The database covered more than 66,000 patients who received oncology biologics and biosimilars in more than 1500 hospitals.

They found that the biosimilar acquisition prices paid by the hospitals to manufacturers (or intermediaries) declined by 60% for bevacizumab, 72% for trastuzumab, and 63% for rituximab over that period. However, reimbursements from insurers declined only by 32%, 36%, and 34%, respectively, resulting in additional profit for the hospital systems.

With the increased profit from these three oncology biosimilar categories, the hospitals increasingly favored the biosimilars over the reference biologics. From 2020 to 2024, hospital uptake of bevacizumab jumped from 32% to 93%. Similar leaps were seen for trastuzumab biosimilars (from 37% to 87%) and for rituximab biosimilars (from 18% to 84%).

These figures would seem counterintuitive, if one considers the pervasive 340B discounts used by hospital systems for outpatient drugs. The authors assumed a 340B discount of 65% of the ASP price. If that is factored in, it would make most sense for the hospital system to purchase at the low 340B price, and seek reimbursement from insurers at the higher price, further widening their profit on each drug utilized. The researchers found that “Hospitals eligible for federal 340B acquisition price discounts were associated with a lower probability to adopt biosimilars than noneligible hospitals for trastuzumab and rituximab.” They also found that “for-profit hospitals were associated with higher probability of biosimilar use for trastuzumab and rituximab.

The study authors believe that gainsharing or shared-savings payment methodologies by Medicare accounted for the overall preference for biosimilars. These gainsharing payment methods, they assert, have also become popular in the private sector as well.

This experience may well be applied to the new oncology biosimilars that will be introduced for Keytruda, Opdivo, and others over the next two to three years.

In Other Biosimilar News

Celltrion announced that its tocilizumab biosimilar (Avtozma) has been launched in the US, marking the first intravenous and subcutaneous biosimilar interleukin-6 receptor antagonist. It is one of three Actemra biosimilars approved in the US.

This article was written by our Director of Content, Stanton Mehr. Stan has been writing commentary and reporting news about the biosimilar industry since the submission of the first biosimilar 351(k) application to the FDA 13 years ago. Since that time, BR&R has been tracking the US biosimilar marketplace, with the industry’s original, comprehensive and updated database of biosimilar filings with the FDA.

This guest commentary is written by Robert Goria, Chief Trade Strategy Officer, CarePartners Pharmacy. The article addresses a practical approach to navigating biosimilar substitution, as we may soon be seeing significant change in the meaning of interchangeability for biosimilars.

The US biologics market is undergoing a quiet but consequential shift. Years after the Biologics Price Competition and Innovation Act created a pathway for biosimilars, regulators and payers are now expanding how these products are distributed, particularly through pharmacy-level substitutions. Although improving access and lowering costs are worthy goals, policies that enable biosimilar substitution without physician involvement raise important concerns about continuity of care, transparency, and patient trust.

Today, federal and state frameworks require a biosimilar to receive an FDA “interchangeable” designation before a pharmacist may substitute it without prescriber consent. However, recent signals from the Centers for Medicare & Medicaid Services suggest a broader practice may emerge, allowing Part D plans to substitute even non-interchangeable biosimilars mid-year for formulary management. In many instances, this practice already occurs when payer policies or PBM’s force a switch among biosimilars or between reference drugs and biosimilars.

Multiple formulary-based changes, especially when tied to payer contracting cycles rather than clinical decision making, risk disrupting care regimens, confusing patients and physicians and serve to erode trust between patients and their providers. Patients trust that clinical decisions will be made by a trusted physician, not by non-transparent formulary updates.

Supporters of pharmacy-driven biosimilar substitution point to faster adoption and cost savings, noting that pharmacy conversions outpace physician prescribed biosimilars. However, biologics are not small-molecule generics. They are complex therapies with immunogenic and clinical nuances. Although FDA-approved biosimilars are deemed safe and effective, many clinicians remain concerned about repeated switching, therapeutic continuity, and patient perception, particularly the potential for “nocebo” effects. Nocebo effect can be defined as “a negative response or harmful effect that occurs because a person expects an adverse outcome, even when the treatment or substance they receive is inactive. It is the opposite of the placebo effect, instead of improving symptoms through expectation, symptoms worsen because of negative expectations.”

Paramount to the topic of interchangeability is the issue of the physician–patient relationship. Patients expect treatment decisions to be made by clinicians who know their history, not by silent formulary changes. Substitution without prescriber awareness can create confusion and erode trust.

There is a practical middle ground. First, real-time prescriber notification should be a baseline requirement. When a biosimilar substitution occurs, interchangeable or otherwise, an automated alert through electronic prescribing systems should notify the clinician immediately. This ensures accurate medication records and appropriate follow-up.

Second, patient education at the point of dispensing must be strengthened. Patients deserve clear, plain-language explanations about what is being substituted, why it is safe, and how it supports their care. Although many states require some form of notification, standards vary widely. A federal baseline would ensure consistent patient protection.

Specialty pharmacies can play a critical role here. Given their close engagement with patients using complex therapies, specialty pharmacists are uniquely positioned to educate patients, coordinate with clinicians, and reinforce that biosimilar switches are clinically sound, not arbitrary cost decisions.

Biosimilars hold real promise, but their success depends on trust built through communication. As substitution policies evolve, transparency, notification, and patient-centered education must be built into the system. Cost savings should never come at the expense of clinical continuity or patient confidence, which are the foundation of good medicine.

This article was written by Robert Goria, Chief Trade Strategy Officer at CarePartners Pharmacy, a national specialty infusion pharmacy focused on niche therapies and markets.

The House of Representatives passed the long-awaited spending bill, and it was signed by President Trump on February 3rd. From the standpoint of health care, the bill failed to extend Affordable Care Act subsidies, but remarkably, major pharmacy benefit manager (PBM) reforms survived the final version.

Meaningful PBM Reforms, Including Rebate Pass Throughs

The Consolidated Appropriations Act of 2026 seeks to delink PBM compensation from Medicare part D list prices and subsequent rebates, opting instead for flat administrative fees. This action would reduce a PBM’s incentive to favor higher priced drugs over generics and biosimilars.

Second, the bill mandates that PBMs fully pass-through rebates they negotiate from manufacturers to plans and plan sponsors. Failure to comply with the provision may result in financial penalties imposed by the Centers for Medicare and Medicaid Services (CMS).

Third, PBMs will be required to report data to payers and plan sponsors at least every six months. The reporting must include data on rebates, formulary rationale, benefit design, spread pricing, and drug spending, all of which were infrequently shared in the past. This attempt at increasing PBM transparency should shine a significant light on the advantages of biosimilar products.

The Department of Health and Human Services will next have to specify the reporting requirements and timelines for implementation.

Rebates not Eliminated, but no Longer a Direct PBM Revenue Source

These reforms have long been sought by plan sponsors. The Act’s provisions go beyond public health plans, extending into the protected realm of ERISA and self-funded plans. In a press release, Shawn Gremminger, President and CEO of the National Alliance of Healthcare Purchaser Coalitions stated, “Today’s bipartisan passage is not only a policy win—it is a long overdue correction to a system that has lacked transparency for far too long. For years, employers have navigated a healthcare marketplace where critical information about pricing, rebates, and formulary decisions were kept out of view. These reforms finally level the playing field and put employers and working families first.”

Removing the ability of PBMs to retain rebate revenue is an important step to ensuring that the PBM acts in the best interests of their clients (i.e., as a fiduciary). However, this part of the equation is not yet been fully solved.

One interesting aspect of this foundational PBM reform is the extent it might stimulate the growth of PBM’s private-label brands. With the Big 3 PBMs already committing to various degrees the move to a pass-through rebate model, they will no doubt focus their efforts on replacing dwindling rebate revenue. Can anyone else imagine a new service fee charged by the PBMs, for simply negotiating the rebate?

The private-label biosimilar is one tool in their tool box, along with new and innovative service fees. It allows the PBM to use spread pricing, like a drug manufacturer, to pocket profits. The end result is that the PBM still has a conflict of interest, in trying to maximize its own profits by dispensing its private- label biosimilar, instead of another, perhaps less-expensive biosimilar agent.

Will These PBM Reforms Necessarily Increase Biosimilar Adoption?

Unfortunately, the rebate pass-through mandate by itself will not help biosimilar uptake: Payers will not be discouraged from preferring rebate-based pricing. Yes, rebates will still be a line item on a health plan’s or sponsor’s bottom line. Therefore, biosimilars with a low WAC price may still be disadvantaged compared with the originator when formulary decisions are made.

Rebates are not paid immediately to the plans, and I don’t believe that patients will benefit at the point of sale from the delayed savings with reduced co-insurance based on the lower net cost. That is yet to be seen. However, once larger employers see the more-transparent, mandated data reports from their PBM on rebates, lower net prices of biosimilars, and the low rate of biosimilar adoption (for biosimilars covered under the pharmacy benefit), the value biosimilars truly provide will also be transparent. This should be enough to demand formulary change—or a move to a PBM acting in the best interest of their clients and beneficiaries.  

This article was written by our Director of Content, Stanton Mehr. Stan is has been writing commentary and reporting news about the biosimilar industry since the submission of the first biosimilar 351(k) application to the FDA 13 years ago. Since that time, BR&R has been tracking the US biosimilar marketplace, with the industry’s original, comprehensive and updated database of biosimilar filings with the FDA.