Why the Distortion in the Pegfilgrastim Market?

Since the first approval of Fulphila in 2018, the pegfilgrastim market has added competitors and steadily decreased in net price through 2022. The latest Samsung Bioepis Biosimilar Market Report indicates that pegfilgrastim biosimilar marketshare is up to 85% in year 7. And two products account for 73% of that total.

The picture has changed considerably since 2022, when IQVIA data reported a 30% biosimilar share. And this figure may eventually grow with Udenyca on-body injector challenging Amgen’s Neulasta OnPro marketshare.

Despite Coherus’ large pegfilgrastim biosimilar marketshare (39%), the company reached a deal in early December with Intas and its subsidiary Accord Biopharma to sell off its Udenyca’s franchise. Besides being the only biosimilar to have an on-body injector, Udenyca is the only pegfilgrastim product to have an autoinjector.

Falling Pegfilgrastim Prices Over Time, but a Very Wide Range of ASPs Today

Pricing for pegfilgrastim products had fallen substantially until 2023, and the mean average sales price (ASP) discount stands at about 54% today (compared with a low of > 70% reported by Samsung Bioepis in October 2023). In October 2023, we were concerned that the ASP was approaching a “pricing floor” and that one product’s ASP had actually fallen off a cliff.  

Sandoz’s Ziextenzo ASP went missing from CMS’s quarterly ASP report at that time, and it reappeared in the January 2025 release, under the nonproprietary name pegfilgrastim-bmez (interestingly, it is the only pegfilgrastim biosimilar listed not by its brand name; a Sandoz source confirmed that this is Ziextenzo, not an unbranded form). Ziextenzo’s newly listed ASP is $296.50 per 6-mg dose (Table), compared with that last published in 2023 ($360.59).

Brand (ManufacturerASP for 6-mg
Injectable Dose
Ziextenzo* (Sandoz)$296.50
Neulasta (Amgen)$239.76
Nyprevia (Pfizer)$1,404.12
Fulphila (Biocon)$1,503.60
Udenyca (Coherus/Intas†)$1,626.60
Fylnetra (Amneal/Kashiv)$2,202.00
Stimufend (Fresenius Kabi)$3,579.60
ASP = Average sales price, published by CMS Dec 2024.
*Listed only as pegfilgrastim-bmez.
†Purchased by Intas in Dec 2024.

However, even this ASP figure is higher than that for Amgen’s reference product Neulasta today, which, at $296.50 per 6-mg dose, is more than 80% below that of the best-selling biosimilar, Udenyca (at $1,626). So, the obvious question is: Why are Udenyca’s and Fulphila’s shares so high, at 39% and 34%, respectively?

Perhaps the most obvious answer remains the fact that providers can buy-and-bill for the higher priced products, and that they gain significantly higher reimbursements with an ASP + 8% formula. But that does not mean that health plans must cover agents with far-higher prices. They can also move to a reference-pricing formula, to discourage use of the higher-priced agent. In this case, they would specify that they will cover the use of any product but offer a fixed-reimbursement amount, reqardless of which agent is used.

Surprise! Lower Prices Don’t Correlate With Plan Coverage

We did a review of pegfilgrastim coverage from a few selected, larger plans. Remember that the vast majority of pegfilgrastim use is covered under the medical, not pharmacy, benefit. A couple of points were notable. For example, Fulphila is covered on tier 2 or 3 (specialty) by Express Scripts (ESI) commercial and Medicare, and BlueCross BlueShield of Illinois (BCBS IL), but it is not covered by UnitedHealth Care (or its affiliated AARP plan), Humana, or Wellcare. It is covered under the medical benefit of other managed care plans.

BCBS IL, which is a subsidiary of the larger Health Care Services Corporation, states in its medical coverage policy that Fulphila and Nyprevia are the preferred products, and that patients must try one of these two before utilizing a nonpreferred agent. At ASPs over $1,400, they are more than 10 times the cost of Neulasta and Ziextenzo.   

Stimufend is not covered on the pharmacy benefit of seven of the eight plans checked. BCBS IL listed it as a tier 3 specialty medication subject to step edits.

For these eight plans, no one pegfilgrastim dominated coverage. It may be time for plans to take a new, closer look at net pegfilgrastim pricing, and take advantage of the discounts gained through biosimilar competition. Reference pricing may be worth a look for these plans.

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