In 2026, the number of EMA-approved and FDA-approved biosimilar drug categories are now even. However, the number of marketed US biosimilars is less than half of that in the EU.
When looking at the approvals by the European Medicines Agency (EMA) of biosimilars since the initial approval back in 2006 for somatropin biosimilar, it becomes clear that the US FDA has caught up in terms of the drug categories for which biosimilars have been approved. However, the total number of approved biosimilars in the UK still far outpaces those in the US, on the order of 168 to 81 (I don’t count each denosumab molecule twice, against the reference products Prolia and Xgeva). That’s in 26 drug categories (compared with 20 in the US).
150 Marketed Biosimilars in the EU
According to the Generics and Biosimilars Initiative (GABI), presently 150 biosimilars are actually available for marketing. Digging into the number of biosimilars available in any one category, such as denosumab, the EMA has approved 14 manufacturers’ products (under 28 different brands), compared with 11 in the US, guaranteeing intense competition.
Several drug categories that the EMA list as biosimilars were not originally considered biologics by the FDA or were converted to the biologic category in 2020; however, this was after pharmaceutical company interest waned in the US for these drugs. This was the case for follitropin, enoxaparin, somatropin, and teriparatide. Basaglar is approved as an insulin glargine biosimilar by the EMA but as an insulin glargine follow-on product (or 505[b]2) by the FDA. And the EMA split epogen biosimilars into two categories, epogen alpha and epogen zeta, for some reason, whereas we only have the former.
There is only one drug category for which the FDA has approved a biosimilar that the EMA hasn’t (at least for now): That is pertuzumab. Partners Henlius and Organon have the sole FDA-approved biosimilar in the category.
Other fascinating areas of difference among the regulatory regions is that there are six ranibizumab biosimilars in the EU as opposed to only two active in the US; there are 14 ustekinumab biosimilars approved by the EMA as opposed to 8 in the US (not including private labels).
Of course, the number of approvals does not foretell the number of launches, especially in the US, where we are still awaiting the first etanercept biosimilar launch, 10 years after Europe’s introduction.
The real question is, who will delve quickly into the biosimilar void?
In Other Biosimilar News
Teva announced on March 30 that it received FDA approval for its Prolia biosimilar Ponlimsi (denosumab-adet). The drug is approved for all of the bone health indications of the reference product Prolia. Originally designated TVB-009, it is also under consideration by the FDA for Xgeva’s oncology bone health indications. It is the 10th denosumab biosimilar approval to date.
In other Teva news, the company also announced that the FDA has accepted its 351(k) application for TEV-45779, its omalizumab biosimilar. An FDA decision is expected in Q1 2027 on this third Xolair biosimilar product.
Five early-stage biosimilar candidates from Samsung Bioepis will be marketed in various parts of the world by Sandoz, including SB36, for which Sandoz will hold marketing rights in the US.
The company specifically announced that its biosimilar for vedolizumab (SB36) will be marketed by Sandoz in the US and in most world markets, excluding Southeast Asia.
Vedolizumab Biosimilars and More in the US?
Beyond this Entyvio biosimilar candidate, Samsung did not suggest that Sandoz would be its US marketing partner for its other biosimilar targets, which include Keytruda, Taltz, Ocrevus, among others. However, Samsung Bioepis did state in its press release that the new agreement covers up to five biosimilar candidates (which may cover various global markets).
“We are very pleased to expand our successful partnership with Sandoz and to secure commercialization agreement for multiple biosimilar assets that are in early-stage development. The agreement is a significant progress in improving access to biologic medicines for patients living with debilitating conditions, who have limited access to life-changing medicines,” said Kyung-Ah Kim, President and Chief Executive Officer, Samsung Bioepis.
This arrangement fortifies Sandoz’s existing partnership with Samsung Bioepis, which already includes marketing agreements for the latter’s ustekinumab (Pyzchiva) and eculizumab (Epysqli) biosimilars. It adds to the roster of biosimilars in Sandoz’s pipeline as well.
Richard Saynor, Chief Executive Officer, Sandoz, stated in a press release, ”This partnership underscores our unwavering commitment to expanding access to affordable, high-quality medicines for patients worldwide. It is another important step toward capitalizing on the unprecedented biosimilar market opportunity over the next decade while also strengthening our partnership with Samsung Bioepis.”
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.
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.
Adapted from Robinson et al. JAMA March 2026
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.
The FDA positions non-US-licensed reference products as adequate for clinical pharmacokinetic investigations and to reduce data redundancy
The FDA on March 10th released new draft guidance for the biosimilar industry that begins to tie together some of the concepts in streamlining biosimilar development that has been discussed for some time now. The new guidance goes beyond the phase 3 comparative efficacy study mandate removal in October 2025 and touches upon the need to test a biosimilar against a US-licensed reference product as well as the need for redundant pharmacokinetic testing requirements.
In the fourth revision of its Q&As on biosimilar development , the FDA specifies that, in certain circumstances, a sponsor can use data from a non-US-licensed reference product for comparison if it can scientifically justify why “such comparative data are relevant to the assessment of biosimilarity to the US-licensed reference product.” This assumes that the non-US product has been approved, licensed, and under the regulatory authority of an organization with similar standards to those of the FDA.
This new guidance could have two significant effects: (1) It would reduce the need for replicative pharmacokinetic investigation (to show the equivalence of the ex-US reference product to the US-licensed reference product and (2) it would remove the need for biosimilar companies to run additional clinical pharmacokinetic studies on a new biosimilar candidate. With reference products costing far less outside the US, not requiring a US-licensed comparator product would save biosimilar manufacturer significant R&D dollars in the purchase of the many doses required for analytic testing.
The FDA also specifies that “Differences in strength or dosage form between the US-licensed reference product and non-US-licensed comparator product do not necessarily preclude use of the non-US-licensed comparator product in a clinical study intended to support a demonstration of biosimilarity.”
This draft guidance does not exactly lead the way to a global comparator product, but it is progress toward that end. Also, one other note, we are still awaiting the final guidance from the FDA, officially removing the clinical efficacy study requirement.
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.
A summary of remarks on PBM reform and the FTC–ESI settlement by speakers at last month’s Association for Accessible Medicines’ Access 2026 conference.
The Association for Accessible Medicines’ (AAM) Access 2026 conference in Miami February 23-25 was perfectly timed to take advantage of perhaps the most important health care—related events of the year: the passage of the Consolidated Appropriation Act’s pharmacy benefit manager (PBM) reforms and the Federal Trade Commission (FTC) settlement with Express Scripts (ESI), which almost certainly will lead to agreements with the other big 3 PBMs. In two sessions at AAM, two main players in shaping PBM reform over several years discuss their reactions and expectations.
On the Long Road to PBM Rebate Changes With Scott Gottlieb
Scott Gottlieb, MD, former FDA Commissioner during the first Trump administration, was part of the effort to enact its Biosimilar Action Plan to nudge biosimilar uptake in the right direction. Another of the pro-biosimilar efforts by he and then Secretary of Health and Human Services Alex Azar was the planned removal of safe harbor protection for drug rebates. Though some of these efforts made it to the finish line, the use of drug rebates to ensure PBM profits and to disadvantage lower-priced pharmaceuticals survived their attempts. At the AAM conference in Miami last week, Dr. Gottlieb restated, “If there was ever PBM actions that can prove their anticompetitiveness, this is it!”
Scott Gottlieb
Dr. Gottlieb believes that “you can take the entire construct we made, tailor it to just these circumstances today. The cost of implementing the rule [to remove the rebate safe harbor] will save money in this narrow biosimilar application.”
Lacking that, he still believes that the settlement between the FTC and ESI “was profound. The issues of the rebates flowing back to consumers, the writing’s on the wall. A lot of the changes are happening absent legislation action.” However, he believes that with the reforms achieved through the Consolidated Appropriations Act of 2026 and the FTC–ESI settlement, “additional PBM reform is unlikely, though we may not have gone far enough,” said Dr. Gottlieb. Still, he believes that CMS can take additional action, in the way it directs companies to design formularies.
ERISA Employers Can Celebrate Freer PBM Markets
A jubilant James Gelfand, JD, President and CEO, The ERISA Industry Committee (ERIC), exclaimed, “We won! We’ve forced transparency on the PBMs, forced pass-through rebates, and we’re ready to celebrate. This will make it very hard for PBMs to make money on arbitrage. We think it’s transformative.”
Mr. Gelfand noted that Congress is still considering additional changes, one of which is to address the request-for-proposal process. This is necessary because of the cozy relationship between the big PBMs and the employer benefit consultants and brokers. “If the PBMs are in cahoots with the brokerage/consulting companies to keep their business, it will make it very hard for these other PBMs to come in with innovative models and to apply fiduciary standards,” he said.
The PBMs have said that employers love rebates, according to Mr. Gelfand, saying they go to the company’s bottom line. ERISA rules prohibit this: “We can’t use the rebates for anything but to reduce healthcare costs.”
James Gelfand
After these reforms are applied, 98% of our employer members still see a role for PBMs, he said. “We don’t want to get into the PBM business.”
Free markets need competition, information, and choice. The rebate pass-through provision is the most important of the reforms. His organization, ERIC, has been advocating for PBMs for many years. Mr. Gelfand remarked, in the Consolidated Appropriations Act of 2021, “we got a provision in place that aimed at revealing the compensation of the vendors that work for employers in employer-sponsored health benefit plans. The Department of Labor interpreted that to mean just brokers and consultants. But from the beginning, we had intended this to also include PBMs. Legislators sent letters to the Department of Labor, telling them they forgot to include PBMs. It took another 5 years to get this changed.”
PBMs and Employer Benefit Consultants: Only a Minor Conflict of Interest?
Employers take advice from consultants and brokers, who help them choose their PBM. They help them decide whether they should be part of a purchasing collaborative, or whether they should contract directly with pharmaceutical companies. “Yet, these third parties are getting paid by the PBM, which makes it not very reliable advice,” asserted Mr. Gelfand. “And we have the same issue with the PBM who tells us, ‘Trust us, you want to go with the AbbVie drug, it’s been out for years, it’s reliable, and the rebate is awesome!’ If I ask them how much of a rebate they receive, they say, ‘We’re not going to tell you that. It’s not important.’”
The Department of Labor will have to unravel the gordian knot of how PBMs profit, opening the employer’s eyes to how PBMs are earning their money. “Employers pay 75 cents out of every health care dollar, so it’s a big deal if we’re being steered towards the higher-priced product. We’ve been ‘trusting’ the PBMs for decades that we’ve been getting the lowest net-cost drugs. But it can’t be explained to us exactly how it’s the lowest net-cost product.”
Instead, the PBM responds, “You have to look across the entire book of business, because having this drug and its bundled rebate is complicated and can’t be easily explained to you.” Mr. Gelfand believes it may be 18 months before a final rule is released by the Department of Labor, but “all that is going to be over.”
We can’t effectively legislate against specific behaviors of the PBM (like spread pricing or rebates) because of the time it takes to pass a Congressional proposal. “The PBMs have very smart people and will always be a step ahead of us, and maybe three steps ahead of Congress because they are so slow to act,” said Mr. Gelfand. “Fundamentally, you can’t just keep going after these rifle shots to legislate their behavior. You must legislate a new business model or paradigm, or they will find ways to get around it. That’s why we think PBMs should be fiduciaries. As a fiduciary, you cannot just invent new ways to cheat your customer. Under ERISA, fiduciaries cannot waste money under the plan, and they must make decisions that are prudent and in the best interests of the beneficiaries of that plan. There’s no way to fit these nasty arbitrage tricks under these two rules. Unfortunately, we’re probably years away from getting this done.”
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.
Takeaways from discussions on the Trump administration’s drug price controls with leaders at last week’s Association for Accessible Medicines’ Access 2026 conference
With all of the chatter on the Web, including in BR&R, on the policy and legislative actions that affect biosimilars, we were eager to hear from some very smart people on the direct-to-patient (DTP) channel as a whole, including TrumpRx; most favored nation (MFN) and Medicare maximum fair price (MFP), among other issues. Although the Blizzard of 2026 prevented us from basking in the sun in Miami, the AAM provided video recordings of the sessions for those who were left in a snow bank. In a two-part post, we’ll relate some of the takeaways from the most compelling discussions.
TrumpRx and DTP: Much Ado About not Too Much?
Brian Reid, Principal, Reid Strategic, and Senior Fellow, Tufts Center for the Evaluation of Value and Risk in Health, reminded the AAM attendees that “direct-to-patient sales were there before TrumpRx.” He believes that perhaps the weight-loss market is viable on these platforms.
Brian Reid
However, in terms of biosimilars and generics, “20 of the 43 drugs listed on TrumpRx have generic alternatives. What are we really talking about here? With generics, you can get a 95% discount,” which is far better than with the TrumpRx price on the brand. Mr. Reid pointed out that “out of a million scripts for pantoprazole written, only 400 are written for the brand Protonix; the rest are generics.”
Mr. Reid mentioned that “Pfizer’s adalimumab biosimilar (Abrilada) is listed on TrumpRx, and it’s the lowest priced adalimumab out there. I know we’re not talking about high-dose or low-dose concentration. It may be a missed opportunity to talk about biosimilars here, beyond the GLP-1s.”
MFN Pricing: Political or Economic Benefit?
Scott Gottlieb, MD, former FDA Commissioner, raised an important MFN pricing issue for biosimilar and originator manufacturers alike: The expected reaction by pharmaceutical manufacturers for a product affected by MFN pricing will be to raise prices in the countries included in the international index on which MFN pricing is based. This then does not directly affect US sales, but it may hinder launches in those countries. Dr. Gottlieb said, “Some launches will be delayed in Europe as a result—there will be harder negotiations for acceptable prices [such as the UK’s NICE]. This will open the market for potential Chinese companies who can launch drugs at lower costs than we can.”
Mr. Reid emphasized that in DC right now, “the talk is about affordability. Why aren’t we getting the policy solutions we need? It’s acknowledged that generics and biosimilars are part of the solution. Instead, lowering drug prices by fiat seems simple, but ignores the [downstream] effects. Everyone seems in favor of price controls, but what happened to market competition,” engendered by biosimilars?
He believes MFN pricing is creating political benefit for the administration but not clear economic benefit. “If the goal is to lower drug prices, it’s not clear that this has happened. It’s a lot easier to threaten foreign countries than to get drug prices lower in the US. People in other countries are very freaked out.”
Sixty Days into MFP Pricing
In January 2026, the initial negotiated Medicare MFP prices were implemented. Within this group of drugs, Stelara stood out. Biosimilar competition began a year ago. Mr. Reid commented that overall, the “Stelara biosimilar market is incredibly competitive, playing out exactly as any economist would want.”
Interfering in this free-market scenario though is the Inflation Reduction Act mandate that if an originator manufacturer agreed to an MFP-negotiated price, that targeted drug cannot be excluded from Medicare formularies. Mr. Reid stated that as a result, “Stelara is carried on every Medicare part D formulary until 2027, which is a huge disservice to consumers and payers. This is a pivotal year for the ustekinumab market, and who wants to lose this pivotal year of that ability for biosimilars to compete against a full-WAC priced product (not artificially lowered). Now we’re living it.”
He pointed out that ustekinumab biosimilars are priced significantly lower than the MFP-negotiated amount. “Taxpayers lost because we didn’t rely on the biosimilar competition solely? Maybe by the time Xolair is up for MFP implementation, CMS will learn its lesson and pull it back,” he said. “The first round of drugs with MFP price controls are on the cusp of generic use. How does this play in with the IRA? How soon should CMS pull drugs out of the MFP program to allow full generic competition in a free market, not an artificially depressed price market?”
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.
Accord BioPharma received approval for Filkri, a filgrastim biosimilar, and Outlook Therapeutics journey to approval for its ONS-5010 continues after an FDA rejection.
A Filkri Approval for AccordBioPharma
In mid-February, Accord BioPharma announced that it had received FDA approval for Filkri (filgrastim-laha), making it the fifth filgrastim biosimilar to obtain approval (not counting Granix, a 505[b]2 product that launched before the biosimilar approval pathway was established). Accord now has both filgrastim and pegfilgrastim biosimilars in its portfolio. It had acquired the Udenyca franchise from Coherus in 2024.
Biosimilar uptake in the filgrastim category (reference product, Neupogen) is approximately 75%, according to the latest Samsung Bioepis Biosimilar Trend Report. The discount in average sales price (ASP) since the introduction of filgrastim biosimilars in 2015 has been 74%.
Outlook Therapeutics Rejected Again by FDA
The battle to bring a manufactured bevacizumab for ophthalmic use is not yet over in the US. Although approved by the European Medicines Agency, Outlook Therapeutics ONS-5010 has been in a long-term journey to US commercialization.
“The [latest complete response letter] identified a single deficiency based on a purported lack of substantial evidence of effectiveness, and recommended submission of additional confirmatory evidence,” according to a press release from February 17. “Outlook Therapeutics believes this determination is inconsistent with the totality of evidence submitted in the [biologic licensing application], including data from an adequate and well-controlled study and confirmatory evidence of effectiveness.” Outlook indicated that discussions with the FDA since September 2025 seemed to indicate alignment with the agency on the important issues. The company has sought additional meetings with the FDA to understand a path forward.
Indeed, we have been following Outlook Therapeutic’s journey for several years, along with its complete response letters in 2023 and 2024. With the low cost of compounded bevacizumab and its high utilization in retinal disease, it was hoped a manufactured version of this product for intravitreal injection would help address safety and purity concerns with compounding and at well below the cost of ranibizumab and aflibercept. However, with heavy biosimilar competition by later this year for the latter, it may be more difficult to leverage a much lower price point for ONS-5010 if launched in 2027.
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.
National PBM reform does not address private labeling by PBMs and their subsidiaries directly, but it does imply that PBM private labels will not hold up over the long term.
Since the announcement of the Federal Trade Commission (FTC) and Express Scripts (ESI) settlement, there has been some speculation regarding the effect of the settlement and national PBM reform overall on the potential growth of the private-label biosimilar channel. Whereas neither the national PBM reform provisions of the Consolidated Appropriations Act (CAA) nor the FTC settlement directly addresses private labeling, you could make the argument that this relatively new revenue channel will be negatively affected.
Spread Pricing Before or After Reaching the Pharmacy
The spread-pricing provisions of the CAA address spread pricing inside the pharmacy but not outside of a pharmacy. That is, a PBM’s distributor, like Cordavis, may purchase the unbranded biosimilar from a manufacturer, like Sandoz, at one price, and relabel it and resell it at a higher price. This is not subject to national PBM reform: Like a drug manufacturer at launch, the distributor can name a list price for its relabeled drug.
A PBM’s Fiduciary Responsibility and Conflict of Interest
The strongest, significant barrier to the private labeling status quo is the fiduciary responsibility imposed on PBMs. A PBM-owned private-label distributor creates a conflict of interest that is hard to reconcile.
Although a PBM’s private-label biosimilar may be amongst the least-expensive drugs available, but for a self-insured employer client, for instance, why would you tolerate this incentive, which allows a PBM to earn more money off the backs of your covered workers?
The PBM’s transparency and reporting mandates would seem to ensure that a potential conflict-of-interest situation is disclosed to its clients. Drug unit sales or at least biosimilar market share must be reported on a regular basis.
Thus, the PBM will have to justify its coverage preference for the private-label brand(s). Again, if pricing of that private-label brand is amongst the best deals around, that might be justification enough.
Take into consideration the costs of a private-label product: A share of the profits must go to the original biosimilar manufacturer as part of this relabeling arrangement. The profits must also pay for any other costs related to the relabeling of the product. This also does not consider any royalties that the biosimilar manufacturer may still be paying to the reference drug maker under any patent or launch settlement. As a result, the private-label product is unlikely to be the least expensive (by net price) biosimilar in a drug category. This is definitely not the case with Quallent’s products, which are more mid-WAC than low-WAC.
Rebate Revenues and the Gap That Must Be Filled
The question thus remains whether the private-label channel will continue to grow in influence or withers away as a result of PBM reform. The mandates for rebate pass-throughs will leave a sizable hole in PBM revenue. As national pressure has ratcheted up the urgency for rebate transparency, the PBMs have been working to shrink their dependence on rebate revenues. This has been achieved mostly by increasing administration and service fees. For the big 3 PBMs, this meant raising new revenues through private labeling. Therefore, PBMs will no doubt be reluctant to drop this relatively new, significant revenue source. It may take several years before the provisions of national PBM reform truly affect the private-label channel. For the biosimilar industry, these are extremely important considerations, as private labeling has, depending on the company and drug, increased and decreased biosimilar market access. For drug categories with heavy competition, every biosimilar company worries about making a private-label deal and the implications for failing to make one.
It should also be noted that private labeling has just entered the realm drugs covered under the medical benefit (e.g., McKesson’s pegfilgrastim private label). The implications of this development in the race for Keytruda and Opdivo biosimilars cannot be overemphasized.
Overall, national PBM reform is a very good thing for the biosimilar industry. If private labels are a casualty of this trend, you won’t find much sympathy on the biosimilar side of the fence.
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.
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.
Amgen’s Pavblu has been the most successful US biosimilar launch by any manufacturer to date, with more than $600 million in net sales in 2025.
The February 3rdearnings report released by Amgen underscore the major success of its Pavblu launch, the first biosimilar competitor to Eylea. For the full year 2025, US net sales were $691 million, the company’s most successful biosimilar launch to date. In the fourth quarter of 2025 alone, Amgen registered $254 million in sales, putting it on a potential path to $1 billion in annual sales, though several other biosimilar competitors will enter the market in 2026.
On a net sales basis—not a prescription volume basis—it would appear that Amgen has a 30% share of the aflibercept non-HD market and a 9% share of the entire aflibercept franchise market. These data support the greater story of this aflibercept biosimilar launch success and the race by Regeneron to move prescriptions to the Eylea HD formulation, before payers prefer the less-expensive biosimilar competition.
The Pavblu launch success was driven by Amgen’s decision to begin marketing the first aflibercept biosimilar at risk, and it will remain the only aflibercept biosimilar on the market until the second half of 2026.
In Other Biosimilar News
Here’s more news on an aflibercept biosimilar launch—this one by Samsung Bioepis. According to a press release, the company and the reference manufacturer Regeneron announced an agreement February 12, allowing the US launch of Samsung Bioepis’ Opuviz in January 2027. At that time, Samsung will have both ranibizumab and aflibercept biosimilars in its ophthalmologic portfolio.
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 14 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.
