On January 22, Sandoz announced that it acquired the ranibizumab biosimilar Cimerli^® from Coherus Biosciences for upwards of $190 million. First approved on August 2, 2022, Cimerli was performing well. According to its manufacturing partner, Formycon AG, the product had grabbed 38% of the ranibizumab marketshare (based on IQVIA data), with $125 million in 2023 sales and trending upward for 2024. So why sell? And why the seemingly low price?

A couple of factors apparently played a role, based on Coherus CEO Dennis Lanfear’s comments on a webcast. One strong reason for the sale is to provide Coherus cash to pay down its loan debt, said Mr. Lanfear. The Cimerli transaction includes an upfront payment by Sandoz of $170 million in cash and an additional $20 million payment for existing Cimerli doses. The cash may also be needed to fund continuing operations.

Despite the strong start in sales, he noted that the company pays a large royalty on Cimerli sales, “which impacts the profit margin significantly. This was the least profitable of their products,” Mr. Lanfear reported. Sales are expected to increase; we recently reported that CVS Health removed Eylea^® and Lucentis^® from its formulary, leaving Cimerli and Byooviz^® as the only options for the intravitreal injectables.

Most recently, Coherus received FDA approval for its Udenyca^® on-body injector device. This delivery system will compete directly with Neulasta^® OnPro^® for the dominant pegfilgrastim marketshare (about 45% of all pegfilgrastim sales). The company may need additional cash to take advantage of its considerable market opportunity in that sector. According to the latest data from the Samsung Bioepis Biosimilar Trend Report, Coherus’ share of the non-OnPro market was 29% in the third quarter of 2023.

The Cimerli transaction includes transfer of Coherus’ ophthalmology sales and select field reimbursement team to Sandoz. Since the company is leaving the ophthalmology field, Mr. Lanfear stated that it is no longer interested in seeking commercialization of its aflibercept biosimilar (FYB203), and the rights to it have been returned to its manufacturing partner. The FDA filing for FYB203 occurred in June 2023, with a decision expected in the early third quarter of this year.

On the other hand, Sandoz has its own aflibercept biosimilar candidate, and an FDA filing may be imminent. The Cimerli agreement with Coherus may provide Sandoz a ready-made ophthalmology sales infrastructure that could be the basis for the marketing of its aflibercept biosimilar as well.

Mr. Lanfear hinted that Coherus may not be done selling biosimilar assets. He stated that both ranibizumab and adalimumab biosimilars are “noncore assets.” The anemic 2023 performance of Yusimry^® has mirrored that of its adalimumab competitors: At 0.3% marketshare, Coherus may seek a buyer for this product as well, as it narrows its focus to the oncology sector. It will likely keep Udenyca, because of its place in the oncology portfolio.

News of the Cimerli sale does confirm that Coherus will not be seeking to bring any new biosimilars to market. Once hailed as a “pure-play” biosimilar manufacturer, it is now evolving into a standard biotech company. Stay tuned for news of similar developments

Earlier this month, Accord BioPharma announced that it had submitted its 351(k) biosimilar application to the FDA for DMB-3115, a proposed ustekinumab biosimilar. An FDA decision may come as early as late Q4 2024.

The application for DMB-3115 includes study results from a phase 3 clinical trial in patients with plaque psoriasis, in which DMB-3115 was found to be noninferior to the reference product Stelara^®.

Biosimilar Developer	Name	Stage/Status
Accord BioPharma/Intas	DMB-3115	FDA application filed Jan 4, 2024. Q4 2024 decision?
Alvotech/Teva	AVT04	351(k) Application filed Jan 6, 2023; FDA rejected Oct 2023
Amgen	Wezlana	Approved Oct 31 as interchangeable; launch date Jan 2025
Biocon	Bmab1200	Phase 3 study to be completed October 2023
Bio-Thera/Hikma	BAT2206	Phase 3 study completed July 2023; FDA filing expected Q1 ‘24
Formycon/Bioeq	FYB202	Phase 3 study completed, filing expected Q4 2023; launch date April 2025
Neuclone	NeuLara	Phase 1 trial underway
Samsung Bioepis	SB17	Phase 3 study completed Nov 2022

In the company’s press release, Chrys Kokino, U.S. President of Accord, stated, “The ability of [ustekinumab] to treat autoimmune diseases is well established, and we’re excited to take this important step toward providing patients a more accessible avenue to treatment for conditions that present such a significant disease burden.”

DMB-3155 represents Accord BioPharma’s third 351(k) application. A biologic licensing application was submitted in April 2023 for HLX02, a biosimilar version of trastuzumab. The company mentioned in its current press release that it also has biologic licensing applications under consideration by the FDA for pegfilgrastim and filgrastim; these are not mentioned on the company’s website and were not publicly announced previously (we could not confirm their status).

Accord BioPharma is the specialty division of India-based Intas Pharmaceuticals, which holds commercialization rights to DMB-3115. The new biosimilar would be manufactured through a partnership with Dong-A Socio Holdings and Meiji Seika Pharma (two South Korean manufacturers), according to the press release.

Accord has a scheduled launch date of no later than May 15, 2025, negotiated with Janssen Biotech, maker of the originator product. This would be the fifth announced launch agreement with Janssen, following those previously disclosed with Amgen, Alvotech/Teva, Fresenius Kabi/Formycon, and Celltrion. At least two other ustekinumab biosimilars may be in the running as well.

As I look back on 2023, the frustration and concern on behalf of the biosimilar industry is inescapable. For adalimumab biosimilar manufacturers, it was a lost year. Period.

The adalimumab market represents the greatest opportunity for biosimilar makers since the approval of Zarxio^®, the first biosimilar approved in the United States. It is certainly the greatest opportunity in terms of monetary savings for the US health system (and may prove to be the GOAT based on savings potential). And save money we did: to the tune of 35% to 40%; we’ll need to wait for the fourth-quarter earnings report to confirm exactly how much.

For AbbVie, maker of the reference product Humira^®, sales of the brand and retention of its marketshare have turned out better than they could have hoped. As we reported in 2023, AbbVie executives were expecting low single-digit loss of share by the end of the year, but a 38% drop in net revenues (which is attributable to significantly increased rebates).

They could not have dreamed that they would lose only 1% of prescriptions over nearly the entire year, according to IQVIA data shared graciously with BR&R. In November 2023, the total number of adalimumab prescriptions written in the US was 848,047. The total prescriptions filled with biosimilars was a paltry 8,726. Do the math. In 2023, payers and PBMs largely grabbed the increased rebates (not lower WAC price offerings) provided by AbbVie to hold off competition. 

The only (meager) positive for the 9 adalimumab biosimilar makers is that the number of biosimilar prescriptions have been increasing each month since July (starting at 3,098), when the bulk of competitors entered the market.

When Amgen launches its high-concentration formulation of Amjevita^®, presumably this month, the market will have the first interchangeable adalimumab in the most commonly used concentration. Will this move the needle in 2024, along with other anticipated launches through the second quarter? Based on the very low uptake of the first low-concentration, interchangeable (Cyltezo^®), the best thing I can say is, “it couldn’t hurt.” Automatic substitution has not been a game-changer for any biosimilar to date.

Furthermore, when AbbVie launches its unbranded version of Humira, at a competitive low-WAC price, the biosimilar makers may find it more difficult to gain ground.

Still, there are some reports of progress. First, the news last week that CVS Caremark will exclude Humira from its major formularies on April 1. Sandoz may be the biggest beneficiary, as CVS works with the biosimilar maker through Cordavis to produce yet another product based on Sandoz’s Hyrimoz^®. However, if it also decides to cover AbbVie’s co-branded product with Cordavis, that would negate any progress here. AbbVie’s offering will not offer any additional savings over the biosimilar competition and will support a company that has made more than $100 billion from the product already (in the US alone).

Congress has ramped up public pressure on PBMs to increase their transparency, which may force a move away from rebates over time. Blue Shield of California’s 2023 announcement of its shift from the traditional PBM contracting model may also be a harbinger of change. That change cannot come soon enough for biosimilars of other products covered under the pharmacy benefit, like ustekinumab, which will be launched next January.

It may take moves by important government players, like the Department of Veterans Affairs or the Centers for Medicare and Medicaid Services, to more aggressively support adalimumab biosimilars, because we know that the commercial payers and PBMs will not do it.

The biosimilar industry has been put into an extraordinarily difficult position. Without uptake of their products in the most costly drug categories, where they are priced very competitively, they will cease to develop biosimilars. And without biosimilar competition, forget cost savings on these originator biologics—instead, you’ll see annual price hikes, lower value, and greater access restrictions.

CVS Health announced on January 3 that it will exclude AbbVie’s Humira from its standard national formularies, effective April 1, 2024.

As a result, CVS Caremark has become the first major pharmacy benefit manager (PBM) to exclude of Humira in favor of biosimilars with “a significantly lower list price than the reference product,” according to the press release.

“For members transitioning to a biosimilar, CVS Caremark will help ensure a seamless experience, including proactive member and prescriber notification of this change 60 days in advance, in addition to follow-up text message reminders and online education. CVS Caremark will meaningfully engage prescribers to guide them through appropriate next steps to help transition plan members. Because current Humira authorizations will be transitioned to the preferred biosimilar products, members and prescribers will not need to obtain a new prior authorization review with this product transition,” the company stated.

From the biosimilar industry’s standpoint, it is crucial for PBMs and plans alike begin to exclude Humira or prefer biosimilar agents over Humira. Based on the 2023 estimates, biosimilars made almost no inroads into AbbVie’s marketshare dominance, despite offering competitive pricing and comparable formulations.

It is unknown how CVS Health’s announcement aligns with the corporate strategy announced last August: that it would produce its own biosimilar adalimumab with Sandoz plays. According to CVS, the new venture Cordavis would be launched sometime in 2024, and it will produce an unbranded biosimilar based on Sandoz’s Hyrimoz^® at a low list price. The company’s most recent announcement did not name which adalimumab biosimilar(s) would be covered in Humira’s absence.  

The Food and Drug Administration published research late last month that showed greater use of biosimilars by patients covered under Medicare Advantage (MA) plans than traditional or fee-for-service (FFS) Medicare.

Based on claims and encounter data for Medicare recipients from May 2015 through September 2022, the researchers included 20 biosimilars (7 drug categories) typically covered in Medicare parts B (FFS) or C (MA). Thirty-six months of utilization was included for each biosimilar’s calculation of marketshare.

The results, published in JAMA Health Forum, demonstrated that for 6 of the 7 drug categories, biosimilar use was greater in MA compared with FFS Medicare. For example, epoetin alfa biosimilars were utilized 2.3-fold more often in MA than in FFS patients (based on a 5.7-percentage point difference in marketshare). Pegfilgrastim biosimilars had 20% greater marketshare (based on a 3.5-percentage point difference). The increased use in MA for other studied drugs included 80% for infliximab (4.1-point difference), 40% for filgrastim (8.4-point difference), 30% for rituximab (9.4-point difference), and 10% for trastuzumab (6.9-point difference).

On the other hand, bevacizumab biosimilars were used 30% less often by MA members compared with FFS Medicare recipients. The researchers attributed this to a difference in ophthalmic vs. oncologic indications. For ophthalmic prescribing, compounded bevacizumab biosimilars (used as an alternative to ranibizumab) were used 70% less often in MA (based on a <0.1-point difference in marketshare), but for oncologic prescribing, bevacizumab biosimilars were associated with 10% greater use in MA versus FFS (based on 6.9-point difference in marketshare).

These results do raise an interesting point. The pharmaceuticals analyzed in this study are primarily buy-and-bill drugs. It makes sense that given a choice in the FFS reimbursement scheme, providers would favor purchasing the higher-priced originator drug. Medicare Advantage plans, which now cover nearly half of all Medicare beneficiaries, utilize drug formularies to prefer one product over another. In the oncology space in particular, the MA plans (as well commercial health plans) prefer covering biosimilars rather than the reference agents. Since the study was undertaken, the reimbursement rate for biosimilars in Medicare has been increased to the average sales price of the reference product + 8% (from 6%). Has this increased reimbursement offset the buy-and-bill incentive on the part of the physician or provider to purchase the higher cost product in FFS Medicare?

On December 26, 2023, Coherus Biosciences announced the end of its long journey to bring competition to the full pegfilgrastim product line. The FDA has approved its on-body injection formulation to compete with Amgen’s Neulasta OnPro^®.

In Coherus’ press release, Danny Lanfear, CEO, stated, “The on-body injector for Udenyca is the result of years of significant investment in research and development to bring forward a novel and proprietary on-body device that provides patients with an automatic delivery option for their medication. Cancer patients and their physicians will now be able to choose the Udenyca administration presentation that best fits their individual needs: a prefilled syringe, our autoinjector, or this on-body injector.”

Udenyca Onbody uses a proprietary injector; this device is not considered a “biosimilar” of OnPro, even though Udenyca is biosimilar to Neulasta. Coherus believes that its own on-body injector will be as well accepted as OnPro, and is in some ways able to provide a better patient experience.

Coherus said that marketing of the on-body injector will begin in the first quarter of 2024. Despite the approval of the first pegfilgrastim biosimilars in 2018, Neulasta OnPro still retains the greatest marketshare, with slightly less than half of the overall category utilization. With this approval, Coherus has the opportunity to be the first to challenge Amgen for dominance in the category. Udenyca, Fulphila^®, Ziextenzo^®, and Neulasta have approximately equal shares of the prefilled syringe market.